Download PDF

Clinical Trial Results:
A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Summary
EudraCT number	2016-004461-47
Trial protocol	DE
Global end of trial date	24 Apr 2020

Results information
Results version number	v1(current)
This version publication date	02 Feb 2022
First version publication date	02 Feb 2022
Other versions
Summary report(s)	SYNERGY-001_Final_Am 1_08Feb2021 - Synopsis

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

DV3-MEL-01[SYNERGY-001]

ISRCTN number

US NCT number

NCT02521870

WHO universal trial number (UTN)

Other trial identifiers

US IND number: 125878

Sponsor organisation name

Dynavax Technologies Corporation

Sponsor organisation address

2100 Powell Street, Suite 900, Emeryville, California, United States, 94608

Public contact

Referat Klinische Prüfung, Paul-Ehrlich-Institut (PEI), +49 6103771811, klinpruefung@pei.de, Paul-Ehrlich-Institut (PEI), klinpruefung@pei.de

Scientific contact

Referat Klinische Prüfung, Paul-Ehrlich-Institut (PEI), +49 6103771811, klinpruefung@pei.de, Paul-Ehrlich-Institut (PEI), klinpruefung@pei.de

Sponsor organisation name

Southwood Research Limited

Sponsor organisation address

Weesperstraat 61, Amsterdam Noord-Holland, Netherlands, 1018 VN

Public contact

Samy Chabri, Southwood Research Limited, +44 (0)7867 645052, samy@southwoodresearch.com

Scientific contact

Samy Chabri, Southwood Research Limited, +44 (0)7867 645052, samy@southwoodresearch.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

08 Feb 2021

Is this the analysis of the primary completion data?

Yes

Primary completion date

24 Apr 2020

Global end of trial reached?

Yes

Global end of trial date

24 Apr 2020

Was the trial ended prematurely?

Yes

Main objective of the trial

Phase 1 (Dose Escalation: Metastatic Melanoma) is closed. • To assess the safety and tolerability of escalating intratumoral doses of SD-101 in combination with intravenous pembrolizumab in patients with metastatic melanoma • To evaluate the expression of IFN-inducible genes in whole blood 24 hours after intratumoral injection of SD-101 given with pembrolizumab in patients with metastatic melanoma as a pharmacodynamic marker of SD-101 activity • To determine an RP2D of SD-101 in combination with pembrolizumab to be evaluated in Phase 2 Phase 2 (Dose Expansion: Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma): •To assess the tumor response both locally and systemically including: -Treatment response of the injected lesion(s) (local response) -Treatment response of the non-injected lesion(s) (systemic response) -Treatment response of all lesions

Protection of trial subjects

This study was conducted in accordance with the protocol, good clinical practice (GCP) as defined in International Council on Harmonisation (ICH) guidelines, and applicable local regulatory requirements. In Phase 1, assessments of injection-site reactions were collected for a minimum of 90 minutes through the first 4 weekly injections and for 30 minutes following the remaining injections of SD-101 at the clinical site. In Phase 2, injection-site reactions that persisted for more than 7 days were recorded as AEs. All other AEs and laboratory safety measurements were graded per NCI CTCAE Version 4.03. All AEs, whether gradable by CTCAE or not, were also to be evaluated for seriousness. AEs were collected through 28 days after the last dose of SD-101. During combination treatment, patients would undergo targeted physical examinations and laboratory assessments, which included a complete blood count (CBC) with differential, platelet assessment, coagulation testing, thyroid function tests, and serum chemistry (including creatinine, liver function tests, and lactate dehydrogenase [LDH]). During monotherapy, safety was evaluated through the careful monitoring of the results of all clinical and laboratory assessments. Injection site reactions were expected to spontaneously subside and adverse reactions could be treated with oral medications. The combination of SD-101 and pembrolizumab was well tolerated in the 4 patient populations evaluated here. The typical adverse reaction to SD-101 is an injection-site reaction or flu-like illness starting the evening of an injection that may include pyrexia, headache, myalgia, malaise, or chills and is treatable with over-the-counter medication. Adding SD-101, an innate immune stimulant, to pembrolizumab, an immune checkpoint blocker, did not lead to an increased rate of irAEs over pembrolizumab monotherapy.

Background therapy

Evidence for comparator

Actual start date of recruitment

01 Sep 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 33

Country: Number of subjects enrolled

New Zealand: 10

Country: Number of subjects enrolled

United States: 186

Country: Number of subjects enrolled

Germany: 12

Worldwide total number of subjects

241

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

116

From 65 to 84 years

116

85 years and over

Subject disposition

Top of page

Recruitment details

Number of Subjects Planned was 24 subjects in Phase 1 Dose Escalation and 260 subjects in Phase 2 Dose Expansion. In final, 241 subjects were enrolled: 22 subjects in Phase 1 Dose Escalation (1 mg n = 6; 2 mg n = 5; 4 mg n = 5; 8 mg n = 6); 219 subjects in Phase 2 Dose Expansion.

Screening details

Routine laboratory tests (serum chemistry, hematology) for screening should be performed within 28 days prior to enrollment or can be obtained from a standard of care visit within 28 days of first dose of pembrolizumab. Laboratories obtained within 7 days of Day 1 visit, with the exception of a CBC with ANC, do not need to be repeated on Day 1.

Period 1 title

Dose expansion study phase 2 (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Blinding implementation details

This is an open-label trial.

Are arms mutually exclusive

Yes

Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg

Arm description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 1 and Cohort 5. Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions.

Arm type

Experimental

Investigational medicinal product name

SD-101

Investigational medicinal product code

SD-101

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intratumoral use

Dosage and administration details

SD-101 drug product was administered by intratumoral injection into a single target lesion. Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions.

Investigational medicinal product name

Pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Pembrolizumab 200 mg was administered intravenously every 3 weeks (Q3W) for two years for up to 35 treatments (35 doses) or until disease progression.

Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg

Arm description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1. Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion if 1 lesion is selected or 2.0 mg per lesion if 2 to 4 lesions are selected for injection

Arm type

Experimental

Investigational medicinal product name

SD-101

Investigational medicinal product code

SD-101

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intratumoral use

Dosage and administration details

SD-101 drug product was administered by intratumoral injection into a single target lesion. Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression.

Investigational medicinal product name

Pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Pembrolizumab 200 mg was administered intravenously every 3 weeks (Q3W) for two years for up to 35 treatments (35 doses) or until disease progression.

Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg

Arm description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8. Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions

Arm type

Experimental

Investigational medicinal product name

SD-101

Investigational medicinal product code

SD-101

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intratumoral use

Dosage and administration details

SD-101 drug product was administered by intratumoral injection into a single target lesion. Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions.

Investigational medicinal product name

Pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Pembrolizumab 200 mg was administered intravenously every 3 weeks (Q3W) for two years for up to 35 treatments (35 doses) or until disease progression.

Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg

Arm description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2. Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion.

Arm type

Experimental

Investigational medicinal product name

SD-101

Investigational medicinal product code

SD-101

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intratumoral use

Dosage and administration details

SD-101 drug product was administered by intratumoral injection into a single target lesion. Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion.

Investigational medicinal product name

Pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Pembrolizumab 200 mg was administered intravenously every 3 weeks (Q3W) for two years for up to 35 treatments (35 doses) or until disease progression.

HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg

Arm description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6. Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions

Arm type

Experimental

Investigational medicinal product name

SD-101

Investigational medicinal product code

SD-101

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intratumoral use

Dosage and administration details

SD-101 drug product was administered by intratumoral injection into a single target lesion. Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions.

Investigational medicinal product name

Pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Pembrolizumab 200 mg was administered intravenously every 3 weeks (Q3W) for two years for up to 35 treatments (35 doses) or until disease progression.

HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg

Arm description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3. Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion

Arm type

Experimental

Investigational medicinal product name

SD-101

Investigational medicinal product code

SD-101

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intratumoral use

Dosage and administration details

SD-101 drug product was administered by intratumoral injection into a single target lesion. Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion.

Investigational medicinal product name

Pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Pembrolizumab 200 mg was administered intravenously every 3 weeks (Q3W) for two years for up to 35 treatments (35 doses) or until disease progression.

HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg

Arm description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7. Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions.

Arm type

Experimental

Investigational medicinal product name

SD-101

Investigational medicinal product code

SD-101

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intratumoral use

Dosage and administration details

SD-101 drug product was administered by intratumoral injection into a single target lesion. Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions.

Investigational medicinal product name

Pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Pembrolizumab 200 mg was administered intravenously every 3 weeks (Q3W) for two years for up to 35 treatments (35 doses) or until disease progression.

HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg

Arm description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4. Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion

Arm type

Experimental

Investigational medicinal product name

SD-101

Investigational medicinal product code

SD-101

Other name

Pharmaceutical forms

Solution for injection in vial

Routes of administration

Intratumoral use

Dosage and administration details

SD-101 drug product was administered by intratumoral injection into a single target lesion. Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion.

Investigational medicinal product name

Pembrolizumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for concentrate for solution for injection/infusion

Routes of administration

Intravenous use

Dosage and administration details

Pembrolizumab 200 mg was administered intravenously every 3 weeks (Q3W) for two years for up to 35 treatments (35 doses) or until disease progression.

Number of subjects in period 1 ^[1]	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Started	45	41	31	30	28	23	23	9
Completed	5	3	0	0	0	0	0	0
Not completed	40	38	31	30	28	23	23	9
Consent withdrawn by subject	3	4	-	1	1	1	2	-
Adverse Event	9	8	-	2	-	-	1	-
Non-Compliance with Study Drug	1	1	-	-	-	-	-	-
Death	1	1	2	1	5	3	2	1
Other	14	6	7	3	5	2	1	1
Lost to follow-up	1	-	-	-	-	-	-	-
Progressive disease	11	18	22	23	17	17	17	7

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: This study was conducted in 2 Phases. Phase 1 enrolled 22 patients for the Dose Escalation to determine an RP2D of SD-101 in combination with pembrolizumab to be evaluated in Phase 2 Dose Expansion. The dose cohorts for SD-101 were 1 mg, 2 mg, 4 mg, and 8 mg. Two RP2Ds were selected (2 mg and 8 mg). Patients who received 1 mg (n=6) or 4 mg (n=5) of SD-101 in the Dose Escalation Phase are not included in phase 2 of the study (n=241 (enrolled for phase 2) - 11 = 230 patients for the analysis set).

Baseline characteristics

Top of page

Reporting group title

Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg

Reporting group description

Reporting group title

Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1. Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion if 1 lesion is selected or 2.0 mg per lesion if 2 to 4 lesions are selected for injection

Reporting group title

Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8. Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions

Reporting group title

Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2. Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion.

Reporting group title

HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6. Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions

Reporting group title

HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3. Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion

Reporting group title

HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7. Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions.

Reporting group title

HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4. Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion

Reporting group values	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg	Total
Number of subjects	45	41	31	30	28	23	23	9	230
Age categorical
Units: Subjects
≤ 18 years	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	16	18	13	17	16	10	15	4	109
≥ 65 years	29	23	18	13	12	13	8	5	121
Age continuous
Age were summarized with descriptive statistics such as mean, standard deviation, median, minimum, and maximum. Age was calculated between a subject's birth date and the date of his/her consent.
Units: years
arithmetic mean (standard deviation)	66.2 ± 13.34	65.3 ± 12.44	65.6 ± 12.99	62.4 ± 15.25	62.6 ± 10.66	67.2 ± 9.59	61.0 ± 12.94	65.2 ± 12.35	-
Gender categorical
Units: Subjects
Female	13	14	10	7	9	2	8	1	64
Male	32	27	21	23	19	21	15	8	166
Race
Count and percentage are reported for categorical variables such as sex, race, and ethnicity.
Units: Subjects
White	44	41	30	25	24	20	19	9	212
Black or African American	1	0	0	0	0	2	2	0	5
Asian	0	0	1	1	2	1	2	0	7
Other	0	0	0	4	2	0	0	0	6
Ethnicity
Count and percentage are reported for categorical variables such as sex, race, and ethnicity.
Units: Subjects
Hispanic or Latino	0	2	1	4	0	0	2	1	10
Not Hispanic or Latino	43	37	28	26	28	22	20	8	212
Unknown or Not Reported	2	2	2	0	0	1	1	0	8

End points

Top of page

Reporting group title

Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg

Reporting group description

Reporting group title

Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 1. Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion if 1 lesion is selected or 2.0 mg per lesion if 2 to 4 lesions are selected for injection

Reporting group title

Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 1 (SD-101 2 mg) and participants in Phase 2 Dose Expansion Cohort 2 and Cohort 8. Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions

Reporting group title

Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 1 Dose Escalation Cohort 3 (SD-101 8 mg) and participants in Phase 2 Dose Expansion Cohort 2. Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion.

Reporting group title

HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3 and Cohort 6. Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions

Reporting group title

HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 3. Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion

Reporting group title

HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4 and Cohort 7. Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions.

Reporting group title

HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg

Reporting group description

Phase 1 Dose Escalation cohorts and Phase 2 Dose Expansion cohorts were rearranged as analysis groups for analyses to assess study objectives, based on tumor indications, anti-PD-1/L1 experience, and dose of SD-101. The participants in this analysis group include participants in Phase 2 Dose Expansion Cohort 4. Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion

Primary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group

Top of page

End point title

Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group ^[1]

End point description

Overall response rate (ORR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS). The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. The objective response rate is defined by the total of CR plus PR of the each relevant subject analysis set. As of Protocol Amendment 9, efficacy and exploratory endpoints were no longer collected. The collection of safety endpoints was simplified.

End point type

Primary

End point timeframe

Day 1 through Day 743

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis: all analysis were descriptive.

End point values	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Number of subjects analysed	45	41	31	30	28	23	23	9
Units: Count of Participants
Complete Response	9	4	0	1	2	0	0	1
Partial Response	25	16	7	3	4	6	2	0
Stable Disease	2	8	8	8	7	5	3	2
Progressive Disease	5	8	12	11	10	9	10	4
Not Evaluable	4	5	4	7	5	3	8	2

No statistical analyses for this end point

Primary: Objective Response Rate

Top of page

End point title

Objective Response Rate ^[2]

End point description

The objective response rate is defined by the total of CR and PR. As of Protocol Amendment 9, efficacy and exploratory endpoints were no longer collected. The collection of safety endpoints was simplified.

End point type

Primary

End point timeframe

Day 1 Through Day 743

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analysis: all analysis were descriptive.

End point values	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Number of subjects analysed	45	41	31	30	28	23	23	9
Units: Counts of participants	34	20	7	4	6	6	2	1

No statistical analyses for this end point

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group

Top of page

End point title

Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group

End point description

Time to objective response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS). The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. This subset of participants analyzed comprises of participants with objective response. As of Protocol Amendment 9, efficacy and exploratory endpoints were no longer collected. The collection of safety endpoints was simplified.

End point type

Secondary

End point timeframe

Day 1 through Day 743

End point values	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Number of subjects analysed	34	20	7	4	6	6	2	1
Units: month
arithmetic mean (standard deviation)	3.2 ± 1.6	4.1 ± 2.96	5.1 ± 3.06	4.3 ± 2.98	2.3 ± 0.92	2.4 ± 0.87	2.7 ± 1.09	2.1 ± 0

No statistical analyses for this end point

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group

Top of page

End point title

Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group

End point description

Duration of response by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS). The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. This subset of participants analyzed comprises of participants with objective response. As of Protocol Amendment 9, efficacy and exploratory endpoints were no longer collected. The collection of safety endpoints was simplified.

End point type

Secondary

End point timeframe

Day 1 through Day 743

End point values	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Number of subjects analysed	34	20	7	4	6	6	2	1
Units: month
arithmetic mean (standard deviation)	11.1 ± 6.42	11.7 ± 5.96	4.6 ± 6.57	7.6 ± 7.28	5.9 ± 4.93	6.3 ± 3.96	2.1 ± 0.07	8.1 ± 0

No statistical analyses for this end point

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group

Top of page

End point title

Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group

End point description

Disease Control Rate (DCR) by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS). The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. As of Protocol Amendment 9, efficacy and exploratory endpoints were no longer collected. The collection of safety endpoints was simplified.

End point type

Secondary

End point timeframe

Day 1 through Day 743

End point values	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Number of subjects analysed	45	41	31	30	28	23	23	9
Units: Participants	36	28	15	12	13	11	5	3

No statistical analyses for this end point

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group

Top of page

End point title

Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group

End point description

Progression-Free Survival (PFS) rate by analysis group based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 was evaluated from Baseline (Day 1) through Day 743 or End of Study (EOS). The intent-to-treat (ITT) population comprises of all participants who were enrolled in the study. As of Protocol Amendment 9, efficacy and exploratory endpoints were no longer collected. The collection of safety endpoints was simplified.

End point type

Secondary

End point timeframe

Day 1 through Day 743

End point values	Melanoma Anti-PD-1/L1 Naïve SD-101 2 mg	Melanoma Anti-PD-1/L1 Naïve SD-101 8 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 2 mg	Melanoma Anti-PD-1/L1 Experienced SD-101 8 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 2 mg	HNSCC Anti-PD-1/L1 Naïve SD-101 8 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 2 mg	HNSCC Anti-PD-1/L1 Experienced SD-101 8 mg
Number of subjects analysed	45	41	31	30	28	23	23	9
Units: Month rate
arithmetic mean (confidence interval 95%)
3-month rate	85.7 (70.9 to 93.3)	71.9 (54 to 83.8)	46.7 (28.4 to 63)	48 (27.8 to 65.6)	46.4 (26.6 to 64.1)	43.5 (23.3 to 62.1)	31.6 (12.9 to 52.2)	37.5 (8.7 to 67.4)
6-month rate	78.4 (62.6 to 88.1)	63.3 (45.2 to 76.8)	33 (17.2 to 49.8)	24 (9.8 to 41.7)	26.5 (10.5 to 45.7)	17.4 (5.4 to 35)	0 (0 to 0)	25 (3.7 to 55.8)
9-month rate	70.8 (54.3 to 82.3)	60.4 (42.4 to 74.4)	21.4 (8.6 to 37.9)	14.4 (3.9 to 31.4)	21.2 (7.1 to 40.3)	17.4 (5.4 to 35)	0 (0 to 0)	12.5 (0.7 to 42.3)
12-month rate	70.8 (54.3 to 82.3)	53.7 (35.7 to 68.7)	21.4 (8.6 to 37.9)	9.6 (1.7 to 25.7)	15.9 (4.2 to 34.4)	8.7 (1.5 to 24.2)	0 (0 to 0)	0 (0 to 0)
15-month rate	65.1 (48.2 to 77.8)	49.9 (31.9 to 65.5)	0 (0 to 0)	9.6 (1.7 to 25.7)	15.9 (4.2 to 34.4)	4.3 (0.3 to 18.2)	0 (0 to 0)	0 (0 to 0)
18-month rate	61.5 (44 to 75)	40.3 (22.3 to 57.7)	0 (0 to 0)	9.6 (1.7 to 25.7)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
21-month rate	61.5 (44 to 75)	40.3 (22.3 to 57.7)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Day 1 through Day 743 For Dose Escalation purposes, a DLT would be defined as any selected AEs as per protocol occurring from the time of the first injection (Day 1) through Study Day 29.

Adverse event reporting additional description

The safety population included all enrolled patients who received at least 1 dose of SD-101. The measures of safety in the trial were routine clinical and laboratory procedures. AEs, SAEs, and abnormal laboratory values were summarized by the proportion of subjects who experienced them.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.1

Reporting group title

SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma

Reporting group description

Dose Expansion Cohort 1: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion if 1 lesion is selected or 2.0 mg per lesion if 2 to 4 lesions are selected for injection Objective: determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma.

Reporting group title

SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma

Reporting group description

Dose Expansion Cohort 2: Participants with melanoma who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion. Determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent or metastatic melanoma.

Reporting group title

SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC

Reporting group description

Dose Expansion Cohort 3: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 8 mg intratumorally starting on Day 22 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion Objective: determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma.

Reporting group title

SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC

Reporting group description

Dose Expansion Cohort 4: Participants with HNSCC who are anti-PD-1/L1-experienced were administered SD-101 8 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 7 doses, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 doses (up to 22 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 8.0 mg in a single lesion Objective: determine the safety and efficacy of SD-101(2) and pembrolizumab in anti-PD-1/L1 therapy progressing patients with recurrent head and neck squamous cell carcinoma.

Reporting group title

SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma

Reporting group description

Dose Expansion Cohort 5: Participants with melanoma who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions. Objective: determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent or metastatic melanoma.

Reporting group title

SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC

Reporting group description

Dose Expansion Cohort 6: Participants with HNSCC who are anti-PD-1/L1-naïve were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions Objective: determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy naïve patients with recurrent head and neck squamous cell carcinoma.

Reporting group title

SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC

Reporting group description

Dose Expansion Cohort 7: Participants with HNSCC who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions. Objective: determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent head and neck squamous cell carcinoma.

Reporting group title

SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma

Reporting group description

Dose Expansion Cohort 8: Participants with melanoma who are anti-PD-1/L1 refractory or resistant were administered SD-101 2 mg intratumorally starting on Day 1 dose Q1W for 4 weeks followed by dose Q3W for 16 doses (up to 20 total doses). Participants were also administered Pembrolizumab 200 mg intravenously Q3W starting on Day 1 for up to 35 treatments or until disease progression. Dose: 2.0 mg per lesion in 1 to 4 lesions Objective: determine the safety and efficacy of SD-101(3) and pembrolizumab in anti-PD-1/L1 therapy refractory or resistant patients with recurrent or metastatic melanoma.

Serious adverse events	SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma	SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma	SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC	SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC	SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma	SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC	SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC	SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Total subjects affected by serious adverse events
subjects affected / exposed	17 / 39 (43.59%)	9 / 30 (30.00%)	5 / 23 (21.74%)	4 / 9 (44.44%)	15 / 44 (34.09%)	8 / 27 (29.63%)	10 / 23 (43.48%)	6 / 31 (19.35%)
number of deaths (all causes)	3	7	13	3	2	6	7	5
number of deaths resulting from adverse events	1	0	0	1	1	3	0	0
Vascular disorders
Hypotension
subjects affected / exposed	2 / 39 (5.13%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Arterial rupture
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	1 / 27 (3.70%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
General disorders and administration site conditions
Influenza like illness
subjects affected / exposed	1 / 39 (2.56%)	1 / 30 (3.33%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Localised oedema
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	1 / 23 (4.35%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	1 / 39 (2.56%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 39 (0.00%)	1 / 30 (3.33%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 44 (2.27%)	0 / 27 (0.00%)	0 / 23 (0.00%)	2 / 31 (6.45%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	2 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Asthenia
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	0 / 39 (0.00%)	1 / 30 (3.33%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	1 / 27 (3.70%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pneumonitis
subjects affected / exposed	1 / 39 (2.56%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	1 / 23 (4.35%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
Respiratory failure
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
Alanine Aminotransferase Increased
subjects affected / exposed	1 / 39 (2.56%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Aspartate Aminotransferase Increased
subjects affected / exposed	1 / 39 (2.56%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Infusion Related Reaction
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	1 / 23 (4.35%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Autoimmune Myocarditis
subjects affected / exposed	1 / 39 (2.56%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Angina Pectoris
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	0 / 39 (0.00%)	1 / 30 (3.33%)	1 / 23 (4.35%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pulseless electrical activity
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	1 / 27 (3.70%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Nervous system disorders
Headache
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 44 (2.27%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolic encephalopathy
subjects affected / exposed	1 / 39 (2.56%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myasthenia gravis
subjects affected / exposed	1 / 39 (2.56%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	1 / 23 (4.35%)	0 / 9 (0.00%)	1 / 44 (2.27%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Embolic stroke
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 44 (2.27%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Eosinophilia
subjects affected / exposed	1 / 39 (2.56%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Febrile Neutropenia
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 44 (2.27%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
Autoimmune retinopathy
subjects affected / exposed	1 / 39 (2.56%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Vomiting
subjects affected / exposed	0 / 39 (0.00%)	2 / 30 (6.67%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 0	3 / 3	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 39 (0.00%)	1 / 30 (3.33%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 44 (2.27%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	2 / 2	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 39 (0.00%)	1 / 30 (3.33%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	0 / 39 (0.00%)	1 / 30 (3.33%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 44 (2.27%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Autoimmune Hepatitis
subjects affected / exposed	1 / 39 (2.56%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Angioedema
subjects affected / exposed	0 / 39 (0.00%)	1 / 30 (3.33%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
Hypophysitis
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 44 (2.27%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Muscular Weakness
subjects affected / exposed	1 / 39 (2.56%)	1 / 30 (3.33%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myositis
subjects affected / exposed	1 / 39 (2.56%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Cellulitis
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	1 / 9 (11.11%)	2 / 44 (4.55%)	1 / 27 (3.70%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	1 / 3	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Meningitis aseptic
subjects affected / exposed	1 / 39 (2.56%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 39 (2.56%)	3 / 30 (10.00%)	1 / 23 (4.35%)	0 / 9 (0.00%)	0 / 44 (0.00%)	2 / 27 (7.41%)	1 / 23 (4.35%)	1 / 31 (3.23%)
occurrences causally related to treatment / all	0 / 1	0 / 3	0 / 1	0 / 0	0 / 0	0 / 2	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Septic Shock
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	0 / 27 (0.00%)	1 / 23 (4.35%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abscess
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	0 / 44 (0.00%)	1 / 27 (3.70%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	3 / 39 (7.69%)	1 / 30 (3.33%)	1 / 23 (4.35%)	0 / 9 (0.00%)	0 / 44 (0.00%)	1 / 27 (3.70%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 1	1 / 1	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 2%

Non-serious adverse events	SD-101 8 mg in Anti-PD-1/L1-Naïve Melanoma	SD-101 8 mg in Anti-PD-1/L1-Experienced Melanoma	SD-101 8 mg in Anti-PD-1/L1-Naïve HNSCC	SD-101 8 mg in Anti-PD-1/L1-Experienced HNSCC	SD-101 2 mg in Anti-PD-1/L1-Naïve Melanoma	SD-101 2 mg in Anti-PD-1/L1-Naïve HNSCC	SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant HNSCC	SD-101 2 mg in Anti-PD-1/L1 Refractory or Resistant Melanoma
Total subjects affected by non serious adverse events
subjects affected / exposed	39 / 39 (100.00%)	30 / 30 (100.00%)	23 / 23 (100.00%)	9 / 9 (100.00%)	44 / 44 (100.00%)	25 / 27 (92.59%)	22 / 23 (95.65%)	31 / 31 (100.00%)
Vascular disorders
Hypertension
subjects affected / exposed	13 / 39 (33.33%)	2 / 30 (6.67%)	2 / 23 (8.70%)	0 / 9 (0.00%)	4 / 44 (9.09%)	1 / 27 (3.70%)	0 / 23 (0.00%)	1 / 31 (3.23%)
occurrences all number	13	2	2	0	4	1	0	1
Nervous system disorders
Headache
subjects affected / exposed	25 / 39 (64.10%)	14 / 30 (46.67%)	10 / 23 (43.48%)	4 / 9 (44.44%)	23 / 44 (52.27%)	3 / 27 (11.11%)	2 / 23 (8.70%)	9 / 31 (29.03%)
occurrences all number	25	14	10	4	23	3	2	9
General disorders and administration site conditions
Fatigue
subjects affected / exposed	31 / 39 (79.49%)	22 / 30 (73.33%)	17 / 23 (73.91%)	5 / 9 (55.56%)	33 / 44 (75.00%)	15 / 27 (55.56%)	7 / 23 (30.43%)	13 / 31 (41.94%)
occurrences all number	31	22	17	5	33	15	7	13
Chills
subjects affected / exposed	20 / 39 (51.28%)	16 / 30 (53.33%)	10 / 23 (43.48%)	1 / 9 (11.11%)	19 / 44 (43.18%)	3 / 27 (11.11%)	2 / 23 (8.70%)	6 / 31 (19.35%)
occurrences all number	20	16	10	1	19	3	2	6
Malaise
subjects affected / exposed	20 / 39 (51.28%)	11 / 30 (36.67%)	0 / 23 (0.00%)	2 / 9 (22.22%)	14 / 44 (31.82%)	0 / 27 (0.00%)	2 / 23 (8.70%)	4 / 31 (12.90%)
occurrences all number	20	11	0	2	14	0	2	4
Injection site erythema
subjects affected / exposed	9 / 39 (23.08%)	13 / 30 (43.33%)	4 / 23 (17.39%)	2 / 9 (22.22%)	17 / 44 (38.64%)	1 / 27 (3.70%)	1 / 23 (4.35%)	4 / 31 (12.90%)
occurrences all number	9	13	4	2	17	1	1	4
Pyrexia
subjects affected / exposed	15 / 39 (38.46%)	7 / 30 (23.33%)	6 / 23 (26.09%)	4 / 9 (44.44%)	10 / 44 (22.73%)	6 / 27 (22.22%)	6 / 23 (26.09%)	7 / 31 (22.58%)
occurrences all number	15	7	6	4	10	6	6	7
Influenza Like Illness
subjects affected / exposed	7 / 39 (17.95%)	4 / 30 (13.33%)	2 / 23 (8.70%)	0 / 9 (0.00%)	13 / 44 (29.55%)	2 / 27 (7.41%)	0 / 23 (0.00%)	10 / 31 (32.26%)
occurrences all number	7	4	2	0	13	2	0	10
Injection Site Pain
subjects affected / exposed	6 / 39 (15.38%)	8 / 30 (26.67%)	0 / 23 (0.00%)	1 / 9 (11.11%)	11 / 44 (25.00%)	0 / 27 (0.00%)	2 / 23 (8.70%)	4 / 31 (12.90%)
occurrences all number	6	8	0	1	11	0	2	4
Injection Site Swelling
subjects affected / exposed	5 / 39 (12.82%)	0 / 30 (0.00%)	3 / 23 (13.04%)	1 / 9 (11.11%)	9 / 44 (20.45%)	2 / 27 (7.41%)	1 / 23 (4.35%)	0 / 31 (0.00%)
occurrences all number	5	0	3	1	9	2	1	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	10 / 39 (25.64%)	4 / 30 (13.33%)	5 / 23 (21.74%)	2 / 9 (22.22%)	7 / 44 (15.91%)	4 / 27 (14.81%)	3 / 23 (13.04%)	4 / 31 (12.90%)
occurrences all number	10	4	5	2	7	4	3	4
Neutropenia
subjects affected / exposed	2 / 39 (5.13%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	1 / 44 (2.27%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences all number	2	0	0	0	1	0	0	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	11 / 39 (28.21%)	7 / 30 (23.33%)	7 / 23 (30.43%)	0 / 9 (0.00%)	21 / 44 (47.73%)	2 / 27 (7.41%)	0 / 23 (0.00%)	6 / 31 (19.35%)
occurrences all number	11	7	7	0	21	2	0	6
Nausea
subjects affected / exposed	15 / 39 (38.46%)	10 / 30 (33.33%)	8 / 23 (34.78%)	0 / 9 (0.00%)	13 / 44 (29.55%)	8 / 27 (29.63%)	0 / 23 (0.00%)	9 / 31 (29.03%)
occurrences all number	15	10	8	0	13	8	0	9
Vomiting
subjects affected / exposed	6 / 39 (15.38%)	6 / 30 (20.00%)	3 / 23 (13.04%)	0 / 9 (0.00%)	6 / 44 (13.64%)	5 / 27 (18.52%)	0 / 23 (0.00%)	6 / 31 (19.35%)
occurrences all number	6	6	3	0	3	5	0	6
Constipation
subjects affected / exposed	3 / 39 (7.69%)	6 / 30 (20.00%)	4 / 23 (17.39%)	0 / 9 (0.00%)	8 / 44 (18.18%)	4 / 27 (14.81%)	0 / 23 (0.00%)	2 / 31 (6.45%)
occurrences all number	3	6	4	0	8	4	0	2
Dysphagia
subjects affected / exposed	2 / 39 (5.13%)	0 / 30 (0.00%)	6 / 23 (26.09%)	0 / 9 (0.00%)	1 / 44 (2.27%)	5 / 27 (18.52%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences all number	2	0	6	0	1	5	0	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	9 / 39 (23.08%)	4 / 30 (13.33%)	0 / 23 (0.00%)	1 / 9 (11.11%)	5 / 44 (11.36%)	0 / 27 (0.00%)	2 / 23 (8.70%)	6 / 31 (19.35%)
occurrences all number	9	4	0	1	5	0	2	6
Cough
subjects affected / exposed	4 / 39 (10.26%)	6 / 30 (20.00%)	2 / 23 (8.70%)	2 / 9 (22.22%)	8 / 44 (18.18%)	3 / 27 (11.11%)	1 / 23 (4.35%)	3 / 31 (9.68%)
occurrences all number	4	6	2	2	8	3	1	3
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	6 / 39 (15.38%)	7 / 30 (23.33%)	4 / 23 (17.39%)	0 / 9 (0.00%)	14 / 44 (31.82%)	2 / 27 (7.41%)	0 / 23 (0.00%)	3 / 31 (9.68%)
occurrences all number	6	7	4	0	14	2	0	3
Rash
subjects affected / exposed	7 / 39 (17.95%)	1 / 30 (3.33%)	1 / 23 (4.35%)	0 / 9 (0.00%)	11 / 44 (25.00%)	2 / 27 (7.41%)	0 / 23 (0.00%)	1 / 31 (3.23%)
occurrences all number	7	1	1	0	11	2	0	1
Psychiatric disorders
Anxiety
subjects affected / exposed	0 / 39 (0.00%)	0 / 30 (0.00%)	3 / 23 (13.04%)	2 / 9 (22.22%)	0 / 44 (0.00%)	1 / 27 (3.70%)	1 / 23 (4.35%)	0 / 31 (0.00%)
occurrences all number	0	0	3	2	0	1	1	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	3 / 39 (7.69%)	1 / 30 (3.33%)	2 / 23 (8.70%)	0 / 9 (0.00%)	11 / 44 (25.00%)	2 / 27 (7.41%)	0 / 23 (0.00%)	1 / 31 (3.23%)
occurrences all number	3	1	2	0	11	2	0	1
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	17 / 39 (43.59%)	16 / 30 (53.33%)	9 / 23 (39.13%)	2 / 9 (22.22%)	18 / 44 (40.91%)	1 / 27 (3.70%)	1 / 23 (4.35%)	2 / 31 (6.45%)
occurrences all number	17	16	9	2	18	1	1	2
Arthralgia
subjects affected / exposed	8 / 39 (20.51%)	4 / 30 (13.33%)	0 / 23 (0.00%)	0 / 9 (0.00%)	16 / 44 (36.36%)	0 / 27 (0.00%)	0 / 23 (0.00%)	3 / 31 (9.68%)
occurrences all number	8	4	0	0	16	0	0	3
Neck Pain
subjects affected / exposed	2 / 39 (5.13%)	0 / 30 (0.00%)	0 / 23 (0.00%)	2 / 9 (22.22%)	1 / 44 (2.27%)	0 / 27 (0.00%)	2 / 23 (8.70%)	0 / 31 (0.00%)
occurrences all number	2	0	0	2	1	0	2	0
Infections and infestations
Cellulitis
subjects affected / exposed	3 / 39 (7.69%)	0 / 30 (0.00%)	0 / 23 (0.00%)	0 / 9 (0.00%)	5 / 44 (11.36%)	0 / 27 (0.00%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences all number	3	0	0	0	5	0	0	0
Metabolism and nutrition disorders
Decreased Appetite
subjects affected / exposed	11 / 39 (28.21%)	9 / 30 (30.00%)	3 / 23 (13.04%)	0 / 9 (0.00%)	11 / 44 (25.00%)	3 / 27 (11.11%)	0 / 23 (0.00%)	3 / 31 (9.68%)
occurrences all number	11	9	3	0	11	3	0	3
Blood Creatinine Increased
subjects affected / exposed	8 / 39 (20.51%)	0 / 30 (0.00%)	2 / 23 (8.70%)	0 / 9 (0.00%)	7 / 44 (15.91%)	1 / 27 (3.70%)	0 / 23 (0.00%)	0 / 31 (0.00%)
occurrences all number	8	0	2	0	7	1	0	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

07 May 2015

Amendment 1

18 Dec 2015

Amendment 2

30 Mar 2016

Amendment 3

23 Sep 2016

Amendment 4

02 Jun 2017

Amendment 5

02 Apr 2018

Amendment 6

22 Jun 2018

Amendment 7

08 Feb 2019

Amendment 8

20 Nov 2019

Amendment 9: the original protocol was amended 9 times. For Protocol Amendment 9 and based on available data from the trial (including efficacy, safety, and pharmacodynamics biomarkers), Cohorts 5 and 6 were CLOSED. Additionally, Cohort 8 (melanoma anti-PD- 1/L1–refractory or resistant) was expanded to approximately 50 patients. Note: As of Protocol Amendment 9, enrollment was closed for all cohorts. Enrolled patients continued to receive their assigned trial treatments as per the protocol. As of Protocol Amendment 9, efficacy and exploratory endpoints were no longer collected. The collection of safety endpoints was simplified.

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
24 Apr 2020	A strategic restructuring including the planned conclusion of clinical oncology development programs and no further sponsoring of the development of SD-101.	-

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

The sponsor terminated the trial early due to strategic restructuring, including the planned conclusion of clinical oncology development programs and no further sponsoring of the development of SD-101.

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group

Primary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group

Primary: Objective Response Rate

Primary: Objective Response Rate

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group

Primary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Overall Response Rate (ORR) by Analysis Group

Primary: Objective Response Rate

Primary: Objective Response Rate

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Time to Objective Response by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Duration of Response by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Disease Control Rate (DCR) by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group

Secondary: Phase 1 Dose Escalation and Phase 2 Dose Expansion - Progression-Free Survival Rate by Analysis Group

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 1b/2, Open-label, Multicenter, Dose-escalation and Expansion Trial of Intratumoral SD-101 in Combination With Pembrolizumab in Patients With Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma