ACTIVE_NOT_RECRUITING

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)

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Conditions

Melanomaprogrammed cell death 1 (PD-1, PD1)programmed cell death ligand 1 (PD-L1, PDL1)T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine receptor motif domains (TIGIT)Cytotoxic T lymphocyte associated protein 4 (CTLA4)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2020-07-01
Study Completion:2030-04-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04305054

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.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has histologically or cytologically confirmed melanoma
  2. * Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
  3. * Has been untreated for advanced disease.
  4. * Has provided a tumor biopsy
  5. * 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):
  6. * 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
  7. * Uses contraception unless confirmed to be azoospermic
  8. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
  9. * Is not a WOCBP OR
  10. * 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:
  11. * MK-4280A: 120 days
  12. * MK-1308A: 120 days
  13. * MK-7684: 50 days
  14. * MK-3475: 120 days
  15. * Lenvatinib: 30 days
  16. * ATRA: 30 days
  17. * Has adequate organ function
  18. * Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia and Grade 2 neuropathy)
  1. * Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days before the first dose of study intervention
  2. * Has a known additional malignancy that is progressing or requires active treatment within the past 2 years
  3. * Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
  4. * Has ocular or mucosal melanoma
  5. * Has an active autoimmune disease that has required systemic treatment in the past 2 years
  6. * Has an active infection requiring systemic therapy
  7. * Has known history of human immunodeficiency virus (HIV)
  8. * Has history of Hepatitis B or known Hepatitis C virus infection
  9. * Has a history of (noninfectious) pneumonitis
  10. * Has a history of active tuberculosis (TB)
  11. * Has received prior systemic anticancer therapy within 4 weeks prior to randomization
  12. * Has received prior radiotherapy within 2 weeks of first dose of study intervention
  13. * Has had major surgery \<3 weeks prior to first dose of study intervention
  14. * Has received a live vaccine within 30 days before the first dose of study intervention
  15. * Has participated in a study of an investigational agent within 4 weeks prior to the first dose of study intervention
  16. * Has had an allogeneic tissue/solid organ transplant
  17. * Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study
  18. * Participants who receive lenvatinib have the following additional

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

The Angeles Clinic and Research Institute ( Site 2009)
Los Angeles, California, 90025
United States
UCLA Hematology & Oncology ( Site 2004)
Los Angeles, California, 90095
United States
Providence Saint John's Health Center ( Site 2010)
Santa Monica, California, 90404
United States
University of Colorado, Anschutz Cancer Pavilion ( Site 2012)
Aurora, Colorado, 80045
United States
University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 2026)
Gainesville, Florida, 32608
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022)
Baltimore, Maryland, 21287
United States
R.J. Zuckerberg Cancer Center ( Site 2032)
Lake Success, New York, 11042
United States
NYU Clinical Cancer Center ( Site 2002)
New York, New York, 10016
United States
Duke Cancer Institute ( Site 2005)
Durham, North Carolina, 27710
United States
Martha Morehouse Tower ( Site 2020)
Columbus, Ohio, 43221
United States
Oregon Health & Science University ( Site 2013)
Portland, Oregon, 97239
United States
University of Pennsylvania Abramson Cancer Center ( Site 2008)
Philadelphia, Pennsylvania, 19104
United States
West Cancer Center - East Campus ( Site 2014)
Germantown, Tennessee, 38138
United States
Mays Cancer Center ( Site 2025)
San Antonio, Texas, 78229
United States
Inova Schar Cancer Institute ( Site 2011)
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

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 Registration Dates

Study Start Date2020-07-01
Study Completion Date2030-04-03

Study Record Updates

Study Start Date2020-07-01
Study Completion Date2030-04-03

Terms related to this study

Keywords Provided by Researchers

  • programmed cell death 1 (PD-1, PD1)
  • programmed cell death ligand 1 (PD-L1, PDL1)
  • T cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine receptor motif domains (TIGIT)
  • Cytotoxic T lymphocyte associated protein 4 (CTLA4)

Additional Relevant MeSH Terms

  • Melanoma