Clinical Trials Register

Summary
EudraCT Number:	2020-005407-38
Sponsor's Protocol Code Number:	MK-3475-B49
National Competent Authority:	Romania - National Agency for Medicines and Medical Devices
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2024-10-11
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Romania - National Agency for Medicines and Medical Devices

A.2

EudraCT number

2020-005407-38

A.3

Full title of the trial

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

This trial is testing pembrolizumab (pembro) + chemotherapy (chemo) in people with certain types of breast cancer called hormone receptor positive/ human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced inoperable or metastatic breast cancer (MBC).

A.3.2

Name or abbreviated title of the trial where available

MK-3475-Pembrolizumab Plus Chemotherapy in HR+/HER2- Metastatic Breast Cancer

A.4.1

Sponsor's protocol code number

MK-3475-B49

A.5.4

Other Identifiers

Name:

IND

Number:

124442

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Merck Sharp & Dohme LLC
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Merck Sharp & Dohme LLC
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck Sharp & Dohme Romania SRL
B.5.2	Functional name of contact point	Clinical Research Director
B.5.3	Address:
B.5.3.1	Street Address	Bulevardul Poligrafiei, Nr. 1A, Etaj 5, Sectorul 1
B.5.3.2	Town/ city	Bucuresti
B.5.3.3	Post code	013704
B.5.3.4	Country	Romania
B.5.4	Telephone number	+40215292900
B.5.5	Fax number	+40213185236
B.5.6	E-mail	elena.aldea@merck.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	KEYTRUDA® (Pembrolizumab, MK-3475)
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme B.V.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pembrolizumab
D.3.9.1	CAS number	1374853-91-4
D.3.9.2	Current sponsor code	MK-3475
D.3.9.4	EV Substance Code	SUB167136
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Treatment of patients with HR+/HER2- locally recurrent inoperable or MBC whose tumors express PD-L1

E.1.1.1

Medical condition in easily understood language

Hormone receptor positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced inoperable or metastatic breast cancer.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	27.0
E.1.2	Level	LLT
E.1.2	Classification code	10027475
E.1.2	Term	Metastatic breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10072740
E.1.2	Term	Locally advanced breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	PT
E.1.2	Classification code	10083232
E.1.2	Term	HER2 negative breast cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

1. To compare pembrolizumab+chemotherapy (CT) to placebo+CT with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥10 and ≥1 tumors, separately.
2. To compare pembrolizumab+CT to placebo+CT with respect to overall survival (OS) in participants with PD-L1 CPS ≥10 and ≥1 tumors, separately.

E.2.2

Secondary objectives of the trial

1. To compare pembrolizumab+CT to placebo+CT with respect to PFS per RECIST 1.1 by investigator in participants with CPS ≥10 and ≥1 tumors, separately.
2. To compare pembrolizumab+CT to placebo+CT with respect to objective response rate (ORR) per RECIST 1.1 by BICR in participants with CPS ≥10 and ≥1 tumors, separately.
3. To compare pembrolizumab+CT to placebo+CT with respect to disease control rate (DCR) per RECIST 1.1 by BICR in participants with CPS ≥10 and ≥1 tumors, separately.
4. To evaluate duration of response (DOR) per RECIST 1.1 by BICR in participants with CPS ≥10 and ≥1 tumors, separately.
5. To evaluate health-related quality of life (HRQoL) assessments using European Organization for Research and Treatment of Cancer QoL
Questionnaire Core 30 (EORTC QLQ-C30) in participants with PD-L1 CPS ≥10 and ≥1 tumors, separately .
6. To evaluate safety and tolerability of pembrolizumab+CT.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting.
2. Has progressed on prior endocrine therapy and is now a chemotherapy candidate, meeting the characteristics in regard to previous treatments of one of the following 4 groups:
GROUP 1: Has progressed on 2 or more lines of endocrine therapy for advanced/metastatic HR+/HER2-disease, with at least 1 given in combination with a CDK4/6 inhibitor. Prior treatment with mTOR and/or PI3-K inhibitors is allowed.
OR
GROUP 2a: Has progressed on 1 line of previous endocrine therapy for advanced/metastatic disease AND had a disease recurrence within 24 months of definitive surgery for the primary tumor and while on adjuvant endocrine therapy. Prior use of CDK4/6 inhibitors is required, either in the adjuvant and/or metastatic setting. Prior treatment with mTOR and/or PI3-K inhibitors is allowed.
OR
GROUP 2b: Has progressed within 12 months of starting 1 line of endocrine therapy with a CDK4/6 inhibitor for advanced/metastatic HR+/HER2- disease.
OR
GROUP 3: If no prior treatment with a CDK4/6 inhibitor for advanced/metastatic disease and/or early stage disease (adjuvant), participants must have progressed within 6 months of starting 1 line of endocrine therapy with or without an mTOR or PI3-K inhibitor for metastatic disease AND had a relapse within 24 months of definitive surgery for primary tumor and while receiving adjuvant endocrine therapy.
3. Has presented a documented radiographic disease progression as assessed by the investigator and/or histology [biopsy or cytology] for participants presenting with new metastatic lesions) during or after the last administered endocrine therapy prior to entering the study.
o There is evidence of radiographic disease progression based on investigator review of at least 2 scans following initiation of the last endocrine therapy (or combination) for metastatic disease.
o A laboratory report indicating tumor marker elevation cannot be used as documentation of local or distant disease recurrence.
4. Is a chemotherapy candidate that meets the following criteria:
o Participants who received taxane and/or anthracyclines (or capecitabine) in the neoadjuvant/adjuvant setting can be treated with same class of chemotherapy (taxane or anthracycline or capecitabine) if ≥12 months have elapsed between the completion of treatment with curative intent and first documented local or distant disease recurrence.
o Participants who will be selected to receive liposomal doxorubicin must have a LVEF of at least 50% or above the institution limit of normal, as assessed by ECHO or MUGA scan performed prior to the first dose administration.
5. Provides a new or the last obtained core biopsy, preferably consisting of multiple cores, taken from a locally recurrent or a distant (metastatic) lesion not previously irradiated for central determination of hormone receptor status (ER and PgR), HER2, and PD-L1 status.
6. Has centrally confirmed PD-L1 CPS ≥1 and HR+ (ER and/or PgR) /HER2– breast cancer as defined by the most recent ASCO/CAP guidelines on most recent tumor biopsy.
7. Has an ECOG Performance Status of 0 or 1, as assessed within 7 days prior to the first dose of study treatment.
8. Demonstrates adequate organ function, within 10 days prior to the start of study treatment.
9. Participants are at least 18 years of age.
10. Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 6 months after the last dose of chemotherapy:
• Refrain from donating sperm
PLUS either:
• Be abstinent from heterosexual intercourse
OR
• Must agree to use contraception unless confirmed to be azoospermic
11. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
• Is not a WOCBP
OR
• Is a WOCBP and using a contraceptive method that is highly effective
12. The participant (or legally acceptable representative if applicable) provides documented informed consent for the study.
13. Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiologist.
14. If receiving bisphosphonates or RANK ligand inhibitors, with stable doses for ≥4 weeks prior to the date of randomization, the participant may continue receiving this therapy during the study treatment. If participant needs to initiate these agents during the screening period, a bone scan to evaluate bone disease should be performed prior to randomization.
15. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization.
16. Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.

E.4

Principal exclusion criteria

1. Has breast cancer amenable to treatment with curative intent.
2. Has a history or current evidence of any condition, therapy, or laboratory abnormality that is specifically contraindicated per the current locally-approved labeling, that might confound the results of the study, interfere with the participant’s involvement for the full duration of the study, or is not in the best interest of the participant to be involved, in the opinion of the treating investigator.
3. Has significant cardiac disease.
4. Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, shortness of breath requiring supplemental oxygen, symptomatic pleural effusion requiring supplemental oxygen, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control.
5. Has skin only disease. Participants who have metastatic disease fulfilling the previous criteria in addition to skin disease can be enrolled.
6. Has a known germline BRCA mutation and has not received previous treatment with PARP inhibition either in the adjuvant or metastatic setting (where available and not medically contraindicated). Single-agent PARP inhibitor therapy does not count as a line of endocrine therapy.
7. Has received prior chemotherapy for locally recurrent inoperable or metastatic breast cancer.
8. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
9. Has received prior systemic anticancer therapy with other investigational agents within 4 weeks prior to randomization.
10. Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
11. Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention.
12. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
13. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
14. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
15. Has known active CNS metastases. Participants with known brain metastases may participate provided that the brain metastases have been previously treated (except with chemotherapy) and are radiographically stable per local radiology/investigator review. To demonstrate radiographic stability of previously treated brain metastases, a minimum of 2 posttreatment brain scan assessments are required:
1) The first brain scan must be acquired after treatment of brain metastases has been completed;
2) The second brain scan must be obtained during screening and ≥4 weeks after the previous posttreatment brain scan.
16. Has diagnosed carcinomatous meningitis.
17. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. Or has any hypersensitivity to the planned chemotherapy agent and/or any of their excipients.
18. Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
19. Has a history of pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
20. Has an active infection requiring systemic therapy.
21. Has a known history of HIV infection.
22. Has a known COVID-19 infection.
23. Has a known history of active TB.
24. Has a known psychiatric or substance abuse disorder including alcohol or drug dependency that would interfere with the participant’s ability to cooperate with the requirements of the study.
25. Is breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days (or longer as specified by local institutional guidelines) after the last dose of study treatment.
26. Has had an allogenic tissue/solid organ transplant.

E.5 End points

E.5.1

Primary end point(s)

1. Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded independent Central Review (BICR) in Participants With CPS ≥10
2. PFS per RECIST 1.1 by BICR in Participants With CPS ≥1
3. Overall Survival (OS) in Participants With CPS ≥10
4. OS in Participants With CPS ≥1

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Up to ~33 months
2. Up to ~33 months
3. Up to ~75 months
4. Up to ~75 months

E.5.2

Secondary end point(s)

1. PFS per RECIST 1.1 by Investigator in Participants With CPS ≥10
2. PFS per RECIST 1.1 by Investigator in Participants With CPS ≥1
3. Objective Response Rate (ORR) per RECIST 1.1 by BICR in Participants With CPS ≥10
4. ORR per RECIST 1.1 by BICR in Participants With CPS ≥1
5. Disease Control Rate (DCR) per RECIST 1.1 by BICR in Participants With CPS ≥10
6. DCR per RECIST 1.1 by BICR in Participants With CPS ≥1
7. Duration of Response (DOR) per RECIST 1.1 by BICR in Participants With CPS ≥10
8. DOR per RECIST 1.1 by BICR in Participants With CPS ≥1
9. Change From Baseline to end of Study in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10
10. Change From Baseline to end of Study in Global Health Status/Quality of Life Score on the EORTC QLQ-C30 in Participants with CPS ≥1
11. Change From Baseline to end of Study in Physical Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥10
12. Change From Baseline to end of Study in Physical Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥1
13. Change From Baseline to end of Study in Emotional Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥10
14. Change From Baseline to end of Study in Emotional Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥1
15. Change From Baseline to end of Study in Fatigue Score on the EORTC QLQ-C30 in Participants with CPS ≥10
16. Change From Baseline in Fatigue Score on the EORTC QLQ-C30 in Participants with CPS ≥1
17. Change From Baseline in Diarrhea Score on the EORTC QLQ-C30 in Participants with CPS ≥10
18. Change From Baseline in Diarrhea Score on the EORTC QLQ-C30 in Participants with CPS ≥1
19. Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the EORTC QLQ-C30 in Participants with CPS ≥10
20. TTD in Global Health Status/Quality of Life Score on the EORTC QLQC30 in Participants with CPS ≥1
21. TTD in Physical Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥10
22. TTD in Physical Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥1
23. TTD in Emotional Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥10
24. TTD in Emotional Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥1
25. TTD in Fatigue Score on the EORTC QLQ-C30 in Participants with CPS≥10
26. TTD in Fatigue Score on the EORTC QLQ-C30 in Participants with CPS ≥1
27. TTD in Diarrhea Score on the EORTC QLQ-C30 in Participants with CPS ≥10
28. TTD in Diarrhea Score on the EORTC QLQ-C30 in Participants with CPS ≥1
29. Percentage of Participants who Experience an Adverse Event (AE)
30. Percentage of Participants who Discontinue Study Drug due to an AE

E.5.2.1

Timepoint(s) of evaluation of this end point

1.Up to ~75 months
2.Up to ~75 months
3. Up to ~75 months
4. Up to ~75 months
5. Up to ~75 months
6. Up to ~75 months
7. Up to ~75 months
8. Up to ~75 months
9. Baseline and up to ~75 months
10. Baseline and up to ~75 months
11. Baseline and up to ~75 months
12. Baseline and up to ~75 months
13. Baseline and up to ~75 months
14. Baseline and up to ~75 months
15. Baseline and up to ~75 months
16. Baseline and up to ~75 months
17. Baseline and up to ~75 months
18. Baseline and up to ~75 months
19. Up to ~75 months
20. Up to ~75 months
21. Up to ~75 months
22. Up to ~75 months
23. Up to ~75 months
24. Up to ~75 months
25. Up to ~75 months
26. Up to ~75 months
27. Up to ~75 months
28. Up to ~75 months
29. Up to ~75 months
30. Up to ~75 months

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Chile

Guatemala

Malaysia

Philippines

Australia

Canada

China

Israel

Japan

Korea, Republic of

Mexico

Russian Federation

United Kingdom

United States

Austria

France

Germany

Greece

Hungary

Ireland

Italy

Netherlands

Poland

Portugal

Romania

Spain

Sweden

Türkiye

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

400

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

311

F.4.2.2

In the whole clinical trial

800

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2023-02-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-02-27

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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Select Trial Status:	Select Trial Phase:
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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
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