Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-005407-38
    Sponsor's Protocol Code Number:MK-3475-B49
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-04-01
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-005407-38
    A.3Full 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.3.1Title 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.3.2Name or abbreviated title of the trial where available
    MK-3475-Pembrolizumab Plus Chemotherapy in HR+/HER2- Metastatic Breast Cancer
    A.4.1Sponsor's protocol code numberMK-3475-B49
    A.5.4Other Identifiers
    Name:INDNumber:124442
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, New Jersey
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number0017325945684
    B.5.6E-mailcarlos.baccan@merck.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name KEYTRUDA® (Pembrolizumab, MK-3475)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of patients with HR+/HER2- locally recurrent inoperable or MBC whose tumors express PD-L1
    E.1.1.1Medical 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.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10072740
    E.1.2Term Locally advanced breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10083232
    E.1.2Term HER2 negative breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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
    E.2.2Secondary objectives of the trial
    1. To compare pembrolizumab + CT to placebo + CT with respect to overall survival (OS) in participants with PD-L1 CPS ≥10 and ≥1
    2. To compare pembrolizumab + CT to placebo + CT with respect to PFS per RECIST 1.1 by investigator in participants with CPS ≥10 and ≥1
    3. 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
    4. 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
    5. To evaluate duration of response (DOR) per RECIST 1.1 by BICR in participants with CPS ≥10 and ≥1
    6. 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
    7. To evaluate safety and tolerability of pembrolizumab + CT
    E.2.3Trial contains a sub-study No
    E.3Principal 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 2 or more lines of endocrine therapy for metastatic HR+/HER2-disease, with at least 1 given in combination with a CDK4/6 inhibitor.
    OR
    Has progressed on 1 line of endocrine therapy for metastatic HR+/HER2- disease and had a relapse within 24 months of definitive surgery for primary tumor while on adjuvant endocrine therapy. Prior treatment with a CDK4/6 inhibitor (in the metastatic and/or adjuvant setting) is required.
    OR
    If no prior treatment with a CDK 4/6 inhibitor, participants must have progressed within 6 months of starting 1 line of endocrine therapy for metastatic disease and had a relapse within 24 months of definitive surgery for primary tumor and while on adjuvant endocrine therapy.
    3. Has presented a documented progression (confirmed by scans per RECIST 1.1 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 PD based on investigator review of at least 2 scans per
    RECIST 1.1 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 in the neoadjuvant/adjuvant setting can be treated with same class of chemotherapy (taxane or anthracycline) 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.
    o Participants who presented with de novo metastatic disease at initial breast cancer diagnosis, are eligible for the study, if they have progressed on 2 or more lines of endocrine therapy for metastatic HR+/HER2- disease, with at least 1 given in combination with a CDK4/6 inhibitor and they present a documented progression during the last administered endocrine therapy prior to entering the study.
    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 90 days 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 written informed consent for the study.
    13. Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiologist.
    14. If receiving bone resorptive therapy, including but not limited to bisphosphonates or denosumab, has been receiving stable doses for ≥4 weeks prior to the date of 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.4Principal 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.
    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 palliative radiotherapy prior to start of study intervention and has not recovered from all radiation-related toxicities and/or requires corticosteroids, and/or has radiation pneumonitis. At least a 1-week washout is required for palliative radiation. Participants who received prior radiotherapy to ≥25% of bone marrow are not eligible regardless of when it was received.
    11. Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention.
    12. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
    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 drug.
    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 to pembrolizumab and/or any of its excipients.
    Or has severe 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. Replacement therapy is not considered a form of systemic treatment and is allowed.
    19. Has a history of pneumonitis that required steroids or has current pneumonitis.
    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 tuberculosis.
    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.5.1Primary 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
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to ~33 months
    2. Up to ~33 months
    E.5.2Secondary end point(s)
    1. Overall Survival (OS) per RECIST 1.1 by BICR in Participants With CPS ≥10
    2. OS per RECIST 1.1 by BICR in Participants With CPS ≥1
    3. PFS per RECIST 1.1 by Investigator in Participants With CPS ≥10
    4. PFS per RECIST 1.1 by Investigator in Participants With CPS ≥1
    5. Objective Response Rate (ORR) per RECIST 1.1 by BICR in Participants With CPS ≥10
    6. ORR per RECIST 1.1 by BICR in Participants With CPS ≥1
    7. Disease Control Rate (DCR) per RECIST 1.1 by BICR in Participants With CPS ≥10
    8. DCR per RECIST 1.1 by BICR in Participants With CPS ≥1
    9. Duration of Response (DOR) per RECIST 1.1 by BICR in Participants With CPS ≥10
    10. DOR per RECIST 1.1 by BICR in Participants With CPS ≥1
    11. 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
    12. 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
    13. Change From Baseline to end of Study in Physical Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥10
    14. Change From Baseline to end of Study in Physical Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥1
    15. Change From Baseline to end of Study in Emotional Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥10
    16. Change From Baseline to end of Study in Emotional Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥1
    17. Change From Baseline to end of Study in Fatigue Score on the EORTC QLQ-C30 in Participants with CPS ≥10
    E.5.2.1Timepoint(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. Up to ~75 months
    10. 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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Chile
    China
    Guatemala
    Israel
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Philippines
    Russian Federation
    Turkey
    United States
    Austria
    France
    Germany
    Greece
    Ireland
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    Sweden
    United Kingdom
    Argentina
    E.8.7Trial 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.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 301
    F.4.2.2In 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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    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.

    European Medicines Agency © 1995-Fri May 02 18:40:29 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA