Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

April 19, 2024 updated by: Merck Sharp & Dohme LLC

A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02B

Substudy 02B is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study.

The goal of substudy 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy.

Arm 1: Pembrolizumab + Vibostolimab was added in the base protocol on 13-Nov-2019, and enrollment into this arm has been completed. Arm 2: Pembrolizumab was added in the base protocol on 13-Nov-2019, and enrollment stopped prematurely on 15-Aug-2022. Arm 3: Coformulation Pembrolizumab/Quavonlimab was added in Amendment 01 on 20-Oct-2020, and enrollment stopped prematurely on 15-Aug-2022. Arm 4: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib was added in Amendment 01 on 20-Oct-2020, and enrollment is ongoing. Arm 5: Coformulation Favezelimab/Pembrolizumab, Arm 6: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA), and Arm 7: Coformulation Favezelimab/Pembrolizumab + Vibostolimab were added in Amendment 04 on 10-May-2023, and enrollment for these arms will be initiated in July 2023.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

315

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Recruiting
        • Calvary Mater Newcastle-Medical Oncology ( Site 2404)
        • Contact:
          • Study Coordinator
          • Phone Number: +61249211561
      • Wollstonecraft, New South Wales, Australia, 2065
        • Recruiting
        • Melanoma Institute Australia ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +61299117321
    • Queensland
      • Southport, Queensland, Australia, 4120
        • Recruiting
        • Tasman Oncology Research Pty Ltd ( Site 2403)
        • Contact:
          • Study Coordinator
          • Phone Number: +61 7 5613 2480
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +61861522222
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4810218
        • Recruiting
        • CIDO SpA-Oncology ( Site 2256)
        • Contact:
          • Study Coordinator
          • Phone Number: 569 5 798 31 73
    • Coquimbo
      • La Serena, Coquimbo, Chile, 1720430
        • Recruiting
        • IC La Serena Research ( Site 2254)
        • Contact:
          • Study Coordinator
          • Phone Number: 56953360057
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 2251)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224457254
      • Santiago, Region M. De Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 2252)
        • Contact:
          • Study Coordinator
          • Phone Number: +56998744662
      • Santiago, Region M. De Santiago, Chile, 7510032
        • Recruiting
        • Oncovida ( Site 2257)
        • Contact:
          • Study Coordinator
          • Phone Number: 5624205100
  • Colombia
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 111321
        • Recruiting
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2261)
        • Contact:
          • Study Coordinator
          • Phone Number: 573103469453
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Recruiting
        • Fundación Valle del Lili ( Site 2265)
        • Contact:
          • Study Coordinator
          • Phone Number: 6023319090
  • France
      • Paris, France, 75010
        • Recruiting
        • A.P.H. Paris, Hopital Saint Louis ( Site 2107)
        • Contact:
          • Study Coordinator
          • Phone Number: +33142499595
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13005
        • Recruiting
        • Hopital La Timone ( Site 2103)
        • Contact:
          • Study Coordinator
          • Phone Number: +33491388591
    • Gironde
      • Bordeaux, Gironde, France, 33075
        • Recruiting
        • CHU de Bordeaux- Hopital Saint Andre ( Site 2108)
        • Contact:
          • Study Coordinator
          • Phone Number: +33556794705
    • Haute-Garonne
      • Toulouse cedex 9, Haute-Garonne, France, 31059
        • Recruiting
        • Institut Claudius Regaud ( Site 2105)
        • Contact:
          • Study Coordinator
          • Phone Number: 33531155675
    • Ile-de-France
      • Villejuif, Ile-de-France, France, 94800
        • Recruiting
        • Gustave Roussy ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: +33142114210
    • Rhone
      • Pierre Benite, Rhone, France, 69495
        • Recruiting
        • C.H. Lyon Sud ( Site 2102)
        • Contact:
          • Study Coordinator
          • Phone Number: +33478861628
  • Greece
      • Thessaloniki, Greece, 57001
        • Recruiting
        • European Interbalkan Medical Center-Oncology Department ( Site 2211)
        • Contact:
          • Study Coordinator
          • Phone Number: 306942608228
    • Attiki
      • Athens, Attiki, Greece, 115 26
        • Recruiting
        • General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 2212)
        • Contact:
          • Study Coordinator
          • Phone Number: 00306944681159
  • Hungary
    • Csongrad
      • Szeged, Csongrad, Hungary, 6720
        • Recruiting
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 2221)
        • Contact:
          • Study Coordinator
          • Phone Number: +36704399976
  • Israel
      • Afula, Israel, 1834111
        • Recruiting
        • HaEmek Medical Center ( Site 2703)
        • Contact:
          • Study Coordinator
          • Phone Number: +97246495723
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Oncology ( Site 2704)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247776700
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Ein Karem Jerusalem ( Site 2702)
        • Contact:
          • Study Coordinator
          • Phone Number: +97226776781
      • Petah-Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center-Oncology ( Site 2705)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-3-9378077
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Chaim Sheba Medical Center ( Site 2701)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235304907
  • Italy
      • Milano, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2399)
        • Contact:
          • Study Coordinator
          • Phone Number: +390223902557
      • Milano, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: +390294372158
      • Napoli, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori Fondazione Pascale ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +390815903431
      • Padova, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS ( Site 2355)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390498215938
      • Siena, Italy, 53100
        • Recruiting
        • Policlinico Le Scotte - A.O. Senese ( Site 2377)
        • Contact:
          • Study Coordinator
          • Phone Number: +390577586335
  • Poland
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
        • Contact:
          • Study Coordinator
          • Phone Number: 48225462031
    • Pomorskie
      • Gdańsk, Pomorskie, Poland, 80-952
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2231)
        • Contact:
          • Study Coordinator
          • Phone Number: 48585844571
  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6055
        • Recruiting
        • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2865)
        • Contact:
          • Study Coordinator
          • Phone Number: +27413630581
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0181
        • Recruiting
        • LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2861)
        • Contact:
          • Study Coordinator
          • Phone Number: +27123466701
      • Sandton, Gauteng, South Africa, 2196
        • Recruiting
        • Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2863)
        • Contact:
          • Study Coordinator
          • Phone Number: +27118830900
      • Tshwane, Gauteng, South Africa, 0002
        • Recruiting
        • Steve Biko Academic Hospital-Medical Oncology ( Site 2862)
        • Contact:
          • Study Coordinator
          • Phone Number: +27123541771
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7570
        • Recruiting
        • Cape Town Oncology Trials ( Site 2864)
        • Contact:
          • Study Coordinator
          • Phone Number: 27219443832
  • Spain
    • Cataluna
      • Barcelona, Cataluna, Spain, 08036
        • Recruiting
        • HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit
        • Contact:
          • Study Coordinator
          • Phone Number: +34932275402
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal ( Site 2802)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913368263
  • Switzerland
    • Geneve
      • Genève, Geneve, Switzerland, 1211
        • Recruiting
        • Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: +41223729862
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Completed
        • CHUV Centre Hospitalier Universitaire Vaudois ( Site 2602)
    • Zurich
      • Zuerich Flughafen, Zurich, Switzerland, 8058
        • Recruiting
        • Universitaetsspital Zuerich ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: +41442552588
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The Angeles Clinic and Research Institute ( Site 2009)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-231-2121
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Hematology & Oncology ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-794-6892
      • Santa Monica, California, United States, 90404
        • Completed
        • Providence Saint John's Health Center ( Site 2010)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado, Anschutz Cancer Pavilion ( Site 2012)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-0442
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022)
        • Contact:
          • Study Coordinator
          • Phone Number: 410-583-2970
    • New York
      • New York, New York, United States, 10016
        • Completed
        • NYU Clinical Cancer Center ( Site 2002)
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Completed
        • Duke Cancer Institute ( Site 2005)
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • Martha Morehouse Tower ( Site 2020)
        • Contact:
          • Study Coordinator
          • Phone Number: 614-293-4320
    • Oregon
      • Portland, Oregon, United States, 97239
        • Completed
        • Oregon Health & Science University ( Site 2013)
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania Abramson Cancer Center ( Site 2008)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-316-5151
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • West Cancer Center - East Campus ( Site 2014)
        • Contact:
          • Study Coordinator
          • Phone Number: 901-683-0055
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Mays Cancer Center ( Site 2025)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-450-5798
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute ( Site 2011)
        • Contact:
          • Study Coordinator
          • Phone Number: 571-472-0631

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has histologically or cytologically confirmed melanoma
  • Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
  • Has been untreated for advanced disease.
  • Has provided a tumor biopsy

  • If capable of producing sperm, male participants agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (7 days):

    • Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR
    • Uses contraception unless confirmed to be azoospermic

  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

    • Is not a WOCBP OR
    • Is a WOCBP and Uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:
    • MK-4280A: 120 days
    • MK-1308A: 120 days
    • MK-7684: 50 days
    • MK-3475: 120 days
    • Lenvatinib: 30 days
    • ATRA: 30 days
  • Has adequate organ function
  • Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia and Grade 2 neuropathy)

Exclusion Criteria:

  • Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days before the first dose of study intervention
  • Has a known additional malignancy that is progressing or requires active treatment within the past 2 years
  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has ocular or mucosal melanoma
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years
  • Has an active infection requiring systemic therapy
  • Has known history of human immunodeficiency virus (HIV)
  • Has history of Hepatitis B or known Hepatitis C virus infection
  • Has a history of (noninfectious) pneumonitis
  • Has a history of active tuberculosis (TB)
  • Has received prior systemic anticancer therapy within 4 weeks prior to randomization
  • Has received prior radiotherapy within 2 weeks of first dose of study intervention
  • Has had major surgery <3 weeks prior to first dose of study intervention
  • Has received a live vaccine within 30 days before the first dose of study intervention
  • Has participated in a study of an investigational agent within 4 weeks prior to the first dose of study intervention
  • Has had an allogeneic tissue/solid organ transplant
  • Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study

  • Participants who receive lenvatinib have the following additional exclusion criteria:

    • Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula
    • Has radiographic evidence of encasement of invasion of a major blood vessel, or of intratumoral cavitation
    • Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study intervention
    • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
    • Has urine protein ≥1 g/24-hour.
    • Has presence of gastrointestinal condition including malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pembrolizumab + Vibostolimab
Participants will receive pembrolizumab intravenously (IV) plus vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Biological: Pembrolizumab
Administered via IV infusion at a specified dose on specified days
Other Names:
  • MK-3475
  • KEYTRUDA®
Biological: Vibostolimab
Administered via IV infusion at a specified dose on specified days
Other Names:
  • MK-7684
Active Comparator: Pembrolizumab
Participants will receive pembrolizumab IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years.
Biological: Pembrolizumab
Administered via IV infusion at a specified dose on specified days
Other Names:
  • MK-3475
  • KEYTRUDA®
Experimental: Coformulation Pembrolizumab/Quavonlimab
Participants will receive coformulation of pembrolizumab and quavonlimab (MK-1308A) IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years.
Biological: Pembrolizumab
Administered via IV infusion at a specified dose on specified days
Other Names:
  • MK-3475
  • KEYTRUDA®
Biological: Pembrolizumab/Quavonlimab
Administered via IV infusion at a specified dose on specified days
Other Names:
  • MK-1308A
Experimental: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib
Participants will receive coformulation of pembrolizumab and quavonlimab IV plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Biological: Pembrolizumab
Administered via IV infusion at a specified dose on specified days
Other Names:
  • MK-3475
  • KEYTRUDA®
Biological: Pembrolizumab/Quavonlimab
Administered via IV infusion at a specified dose on specified days
Other Names:
  • MK-1308A
Drug: Lenvatinib
Administered via oral capsule at a specified dose on specified days
Other Names:
  • E7080
  • MK-7902
  • LENVIMA®
Experimental: Coformulation Favezelimab/Pembrolizumab
Participants will receive cofomulation of favezelimab + pembrolizumab (MK-4280A) IV at specified dose on specified days every 3 weeks (Q3W) for up to approximately 2 years
Biological: Favezelimab/Pembrolizumab
Administered via IV infusion at a specified dose on specified days
Other Names:
  • MK-4280A
Experimental: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA)
Participants will receive coformulation of favezelimab and pembrolizumab IV Q3W for up to 35 cycles, plus ATRA orally (for 3 days surrounding each infusion of MK-4280A, including Days 1, 2, and 3 of Cycle 1 and on Days -1, 1, and 2 of all subsequent cycles).
Drug: ATRA
Administered via oral capsule at a specified dose on specified days
Experimental: Coformulation Favezelimab/Pembrolizumab + Vibostolimab
Participants will receive coformulation of favezelimab and pembrolizumab (MK-4280A) IV and vibostolimab IV at specified doses on specified days for a total treatment duration of up to approximately 2 years.
Biological: Vibostolimab
Administered via IV infusion at a specified dose on specified days
Other Names:
  • MK-7684
Biological: Favezelimab/Pembrolizumab
Administered via IV infusion at a specified dose on specified days
Other Names:
  • MK-4280A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who experience an adverse event (AE)
Time Frame: Up to ~28 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience an AE will be reported.
Up to ~28 months
Percentage of participants who discontinue study treatment due to an AE
Time Frame: Up to ~24 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Up to ~24 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
Time Frame: Up to ~30 months
ORR is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR). RECIST 1.1 has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Up to ~30 months
Percentage of participants who experience a dose-limiting toxicity (DLT): Safety lead-in phase
Time Frame: Up to ~3 weeks
The percentage of participants who experience 1 or more protocol-defined DLTs during the safety lead-in period will be reported.
Up to ~3 weeks
Percentage of participants who experience an adverse event (AE): Safety lead-in
Time Frame: Up to ~3 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience an AE during the safety lead-in period will be reported.
Up to ~3 weeks
Percentage of participants who discontinue study treatment due to an AE: Safety lead-in
Time Frame: Up to ~3 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study treatment due to an AE during the safety lead-in will be reported.
Up to ~3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) per RECIST 1.1
Time Frame: Up to ~30 months
For participants in the analysis population who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by BICR. RECIST 1.1 has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Up to ~30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Estimated)

April 3, 2030

Study Completion (Estimated)

April 3, 2030

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-02B
  • KEYMAKER-U02 (Other Identifier: Merck)
  • MK-3475-02B (Other Identifier: Merck)
  • 2019-003977-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Melanoma

Clinical Trials on Pembrolizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe