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)

Description

Substudy 02B is part of a larger research study where researchers are looking for new ways to treat advanced melanoma that has not been treated before. The larger study is the umbrella study. Researchers want to know if adding other treatments to pembrolizumab can treat advanced melanoma. The goals of this study are to learn: * About the safety and how well people tolerate pembrolizumab given with other treatments * How many people have melanoma that responds (gets smaller or goes away) to treatment 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 was added in Amendment 03 on 01-DEC-2022 and has paused enrollment, Arm 6: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA) was added in Amendment 03 on 01-DEC-2022 and has paused enrollment, and Arm 7: Coformulation Favezelimab/Pembrolizumab + Vibostolimab was added in Amendment 03 on 01-DEC-2022 and enrollment was stopped prematurely on 22-SEP-2023.

Conditions

Melanoma

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Study Overview

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Study Details

Study overview

Substudy 02B is part of a larger research study where researchers are looking for new ways to treat advanced melanoma that has not been treated before. The larger study is the umbrella study. Researchers want to know if adding other treatments to pembrolizumab can treat advanced melanoma. The goals of this study are to learn: * About the safety and how well people tolerate pembrolizumab given with other treatments * How many people have melanoma that responds (gets smaller or goes away) to treatment 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 was added in Amendment 03 on 01-DEC-2022 and has paused enrollment, Arm 6: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA) was added in Amendment 03 on 01-DEC-2022 and has paused enrollment, and Arm 7: Coformulation Favezelimab/Pembrolizumab + Vibostolimab was added in Amendment 03 on 01-DEC-2022 and enrollment was stopped prematurely on 22-SEP-2023.

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: 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)

Condition
Melanoma
Intervention / Treatment

-

Contacts and Locations

Los Angeles

The Angeles Clinic and Research Institute ( Site 2009), Los Angeles, California, United States, 90025

Los Angeles

UCLA Hematology & Oncology ( Site 2004), Los Angeles, California, United States, 90095

Santa Monica

Providence Saint John's Health Center ( Site 2010), Santa Monica, California, United States, 90404

Aurora

University of Colorado, Anschutz Cancer Pavilion ( Site 2012), Aurora, Colorado, United States, 80045

Gainesville

University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 2026, Gainesville, Florida, United States, 32610

Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022), Baltimore, Maryland, United States, 21287

Lake Success

R.J. Zuckerberg Cancer Center ( Site 2032), Lake Success, New York, United States, 11042

New York

NYU Clinical Cancer Center ( Site 2002), New York, New York, United States, 10016

Durham

Duke Cancer Institute ( Site 2005), Durham, North Carolina, United States, 27710

Columbus

Martha Morehouse Tower ( Site 2020), Columbus, Ohio, United States, 43221

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 120 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2030-04-03