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    Clinical Trial Results:
    A Phase 1b/2 Study to Evaluate Safety and Clinical Activity of Avelumab in Combination with Bempegaldesleukin (NKTR-214) with or without Talazoparib or Enzalutamide in Participants with Locally Advanced or Metastatic Solid Tumors

    Summary
    EudraCT number
    2019-001358-24
    Trial protocol
    PL   IT   ES   BE  
    Global end of trial date
    29 Sep 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Sep 2021
    First version publication date
    08 Sep 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    B9991040
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04052204
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 East 42nd Street, New York, NY, United States, 10017-5755
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., Pfizer Inc., +1 8007181021, ClinicalTrails.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., Pfizer Inc., +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary object of this trial was to assess the dose-limiting toxicity (DLT) rate of avelumab in combination with bempegaldesleukin (NKTR-214) (Combination A) to determine the recommended Phase 2 dose (RP2D) for the combinations.
    Protection of trial subjects
    This study was conducted in compliance with the ethical principles originated or derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All local regulatory requirements were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Dec 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Spain: 1
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    4 subjects screened for this study, 1 of the 4 subjects was a screen failure, 3 subjects were enrolled and received study treatment in Combination A.

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Arm description
    NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).
    Arm type
    Experimental

    Investigational medicinal product name
    Bempegaldesleukin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Each subject’s NKTR-214 dose was determined based on the subject’s weight in kilograms on Day 1 of each cycle. NKTR-214 was administered prior to avelumab. NKTR-214 was administered IV over 30 (± 5) minutes every 2 weeks (+/- 2 days).

    Investigational medicinal product name
    Avelumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Avelumab was administered at 800 mg as a 1-hour (-10/+20 minutes) IV infusion starting after the NKTR-214 and talazoparib or enzalutamide (where applicable) was administered, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle.

    Number of subjects in period 1
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Started
    3
    Completed
    0
    Not completed
    3
         Death
    1
         Other
    1
         Progressive disease
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Reporting group description
    NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).

    Reporting group values
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) Total
    Number of subjects
    3 3
    Age Categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    2 2
        From 65-84 years
    1 1
        85 years and over
    0 0
    Age Continuous
    Units: years
        median (full range (min-max))
    64.00 (56.0 to 65.0) -
    Gender Categorical
    Units: Subjects
        Female
    1 1
        Male
    2 2
    Race
    Units: Subjects
        Black or African American
    0 0
        American Indian or Alaska Native
    0 0
        Asian
    0 0
        Native Hawaiian or Other Pacific Islander
    0 0
        White
    3 3
        Multiracial
    0 0
        Not reported
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Reporting group description
    NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25).

    Primary: Number of Subjects with Dose Limiting Toxicities (DLT)

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    End point title
    Number of Subjects with Dose Limiting Toxicities (DLT) [1]
    End point description
    DLTs were graded according to NCI- CTCAE version 4.03 and coded using the latest version of Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT) as event category and MedDRA primary system organ class (SOC) body term as Body System category. The DLT-evaluable analysis set was a subset of the safety analysis set and included all enrolled subjects in Phase 1b who received at least one dose of the combination treatment and either experienced DLT during the first cycle (28 days) of treatment, or completed the DLT observation period for the first cycle of treatment without a DLT.
    End point type
    Primary
    End point timeframe
    Cycle 1 of the treatment period (28 days)
    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 was planned for this endpoint
    End point values
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Number of subjects analysed
    3
    Units: Subjects
        Number of Subjects Reported:
    1
    No statistical analyses for this end point

    Secondary: Duration of Response (DR)

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    End point title
    Duration of Response (DR)
    End point description
    DR was defined, for subjects with a confirmed Objective Response (OR), as the time from the first documentation of OR to the date of first documentation of progressive disease (PD) or death due to any cause. The documentation of PD was defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. If a subject had not had an event (PD or death), DR was censored at the date of last adequate tumor assessment. All subjects treated in combination A who achieved an OR were analyzed.
    End point type
    Secondary
    End point timeframe
    Approximately 8 months (246 days).
    End point values
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Number of subjects analysed
    0 [2]
    Units: months
        median (confidence interval 95%)
    ( to )
    Notes
    [2] - As there were no ORs in the study, no participant met the definition of analysis population.
    No statistical analyses for this end point

    Secondary: Time to Tumor Response (TTR)

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    End point title
    Time to Tumor Response (TTR)
    End point description
    TTR was defined, for subjects with OR, as the time from the date of first dose of study treatment to the first documentation of objective response (Complete Response or Partial Response) which was subsequently confirmed. All subjects treated in combination A who achieved an OR were analyzed. 99999 indicates that TTR was not analyzed due to no objective responses in the study.
    End point type
    Secondary
    End point timeframe
    Approximately 8 months (246 days).
    End point values
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Number of subjects analysed
    0 [3]
    Units: months
        median (full range (min-max))
    ( to )
    Notes
    [3] - As there were no ORs in the study, no participant met the definition of analysis population.
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

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    End point title
    Progression-Free Survival (PFS)
    End point description
    Progression-Free Survival (PFS): the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first. PFS data were censored on the date of the last adequate tumor assessment for subjects who did not have an event (PD or death), for subjects who started new anti-cancer therapy prior to an event, or for subjects with an event after two or more missing tumor assessments. Subjects who did not have an adequate baseline tumor assessment or who did not have any adequate post-baseline tumor assessments were censored on the date of first dose of study treatment unless death occurred on or before the time of the second planned tumor assessment, in which case death was considered an event. Two subjects had best overall response of PD and 1 was not evaluable due to early death. One subject died on days 18, another died on day 77. 99999 indicates no summaries of PFS endpoints, because N<= 3.
    End point type
    Secondary
    End point timeframe
    Approximately 8 months (246 days).
    End point values
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Number of subjects analysed
    3
    Units: months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    Overall Survival (OS)
    End point description
    OS was defined as the time from the first dose of study treatment to the date of death due to any cause. Patients last known to be alive were censored at date of last contact. All subjected treated in combination A were analyzed. one subject died 18 after the first dose of treatment, 1 patient did 77 days after first dose of treatment. the 3 subject was censored 191 days after first dose (first dose date 23Mar2020, end of study 29Sep2020). 99999 indicates that there were no summaries of OS endpoints, because N<= 3.
    End point type
    Secondary
    End point timeframe
    Approximately 8 months (246 days)
    End point values
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Number of subjects analysed
    3
    Units: months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Pharmacokinetic (PK) parameters - Cmax and Ctrough for Avelumab and NKTR-214

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    End point title
    Pharmacokinetic (PK) parameters - Cmax and Ctrough for Avelumab and NKTR-214
    End point description
    Cmax was defined as the maximum observed plasma concentration at the end of infusion. Ctrough was defined as the predose concentration at the end of dosing interval. The PK parameter analysis set was a subset of the safety analysis set and included subjects who had at least one of the PK parameters of interest for avelumab, NKTR-214, IL-2, talazoparib, enzalutamide, or N-desmethyl-enzalutamide. 99999 indicates that there were no summaries and interpretations of PK results available, because N<=3 in the PK analysis set.
    End point type
    Secondary
    End point timeframe
    Blood samples were collected on Day 1 and Day 15 in Cycle 1 and Cycle 2 for avelumab. Blood samples were collected on Day 1, Day 3, Day 4 and Day 8 in Cycle 1, Day1 and Day 8 in Cycle 2 for NKTR-214.
    End point values
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Number of subjects analysed
    3
    Units: ug/mL
        median (confidence interval 95%)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Positive Anti-Drug Antibody (ADA) Results

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    End point title
    Number of Subjects with Positive Anti-Drug Antibody (ADA) Results
    End point description
    ADA against avelumab and NKTR-214 in serum samples was determined and reported separately for ADA never-positive, ADA ever-positive, baseline ADA positive, treatment-boosted ADA, treatment-induced ADA, transient ADA response, Persistent ADA response. For all subjects, blood for ADA samples will be drawn from the contralateral arm of the avelumab and NKTR-214 infusion. The immunogenicity analysis set was a subset of the safety analysis set and included subjects who had at least one ADA/nAb sample collected for avelumab, NKTR-214, or IL-2. 99999 indicates that ADA results were not analyzed for this study due to study termination.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1, Cycle 2 and end of treatment (EOT).
    End point values
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Number of subjects analysed
    3
    Units: Subjects
    99999
    No statistical analyses for this end point

    Secondary: Number of Subjects with Positive Neutralizing Antibody (nAb) Results

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    End point title
    Number of Subjects with Positive Neutralizing Antibody (nAb) Results
    End point description
    Samples positive for ADA were analyzed for nAb, nAb in serum samples was determined and reported separately for nAb never-positive, nAb ever-positive, baseline nAb positive, treatment-induced nAb, transient nAb response, persistent nAb response. The immunogenicity analysis set was a subset of the safety analysis set and included subjects who had at least one ADA/nAb sample collected for avelumab, NKTR-214, or IL-2. 99999 indicates that nAb results were not analyzed for this study due to study termination.
    End point type
    Secondary
    End point timeframe
    Day 1 of Cycle 1, Cycle 2, and EOT.
    End point values
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Number of subjects analysed
    3
    Units: Subjects
    99999
    No statistical analyses for this end point

    Secondary: PD-L1 Expression Level in Baseline and On-treatment Tumor Tissue

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    End point title
    PD-L1 Expression Level in Baseline and On-treatment Tumor Tissue
    End point description
    PD-L1 expression level in baseline tumor tissue, and in on-treatment tumor tissue was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and/or inflammatory cells in regions of interest. PD-L1 expression level in baseline tumor tissue and in on-treatment tumor tissue were under pathological analyses, assisted by image analysis. Subjects were classified as positive or negative according to scoring algorithms and cut-offs established from internal or external sources. The biomarker analysis set for biomarkers that were only measured at screening was a subset of the safety analysis set and included subjects who had at least one baseline biomarker assessment. 99999 indicates that no biomarker data (PD-L1) were analyzed for this study due to early study termination.
    End point type
    Secondary
    End point timeframe
    On-treatment biopsy was required to be collected on Cycle 1 between Days 9 and 14 for subjects in Combination A.
    End point values
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Number of subjects analysed
    3
    Units: Subjects
    99999
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period

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    End point title
    Number of Subjects with Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period
    End point description
    Adverse events (AEs) were any untoward medical occurrences in a subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse events (TEAEs) were those events with onset dates occurring during the on-treatment period, which was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment). A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that, at any dose: a. Results in death, b. Was life-threatening, c. Required inpatient hospitalization or prolongation of existing hospitalization, d. Resulted in persistent disability/incapacity, e. Was a congenital anomaly/birth defect. Causality to study treatment was determined by the investigator. The safety analysis set included all subjects who received at least one dose of study drug. "Treatment-Related" is abbreviated as "TR" “All-Causality” is abbreviated as “AC”
    End point type
    Secondary
    End point timeframe
    Approximately 6 months (190 days)
    End point values
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Number of subjects analysed
    3
    Units: Subjects
        Subjects with AC TEAEs
    3
        Subjects with grade ≥ 3 AC TEAEs
    2
        Subjects with TR TEAEs
    3
        Subjects with grade ≥ 3 TR TEAEs
    1
        Subjects with serious AC TEAEs
    1
        Subjects with serious TR TEAEs
    1
        Subjects with AC TEAEs leading to death
    1
        Subjects with TR TEAEs leading to death
    1
        Subjects with IRRs
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Laboratory Abnormalities

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    End point title
    Number of Subjects with Laboratory Abnormalities
    End point description
    Liver Function Tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) were used to assess possible drug induced liver toxicity. The number of subjects with at least one of the following laboratory results were summarized below: 1. (ALT ≥3 × ULN or AST ≥3 × ULN) post-baseline. 2. TBILI ≥2 × ULN post-baseline. 3. (ALP ≤2 × ULN or missing) post-baseline.
    End point type
    Secondary
    End point timeframe
    Day 1, Day 15 of each treatment cycle
    End point values
    Avelumab + Bempegaldesleukin (NKTR-214) (Combination A)
    Number of subjects analysed
    3
    Units: Subjects
        Subjects with at least one NCI-CTCAE Grade ≥3
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the subject provided informed consent to a minimum of 90 calendar days after the last administration of the investigational product.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Dose-Finding for Combination A
    Reporting group description
    Subjects were administrated 800mg avelumab plus 0.006mg/kg bempegaldesleukin(NKTR-214) intravenous(IV) every 2 weeks (Q2W)

    Serious adverse events
    Dose-Finding for Combination A
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Dose-Finding for Combination A
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Platelet count increased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Weight decrease
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fal
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    7
    Asthenia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    4
    Influenza like illness
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    General physical health deterioration
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    5
    Musculoskeletal pain
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    6
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jun 2019
    This amendment is to expand the Dose Limiting Toxicity(DLT) criteria following the feedback received from the FDA during the IND application review.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Only Phase 1b of Combination A was conducted as company terminated this study on 21 May 2020. Termination was not due to a regulatory request or new emerging safety signals. Combination B, C and Phase 2 expansion for Combination A were not tested.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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