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NCT04303169CompletedPhase 1/2

Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)

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 02C

Source: ClinicalTrials.gov · Last updated 27 Aug 2026

Brief summary (registry, in English)

Substudy 02C 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 02C is to evaluate the safety and efficacy of investigational treatment arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. Arm 1: Pembrolizumab + Vibostolimab, Arm 2: Pembrolizumab + Gebasaxturev, and Arm 3: Pembrolizumab were added in the base protocol on 13-Nov-2019, and enrollment into those arms has been completed. Arm 4: Pembrolizumab + MK-4830 was added in Amendment 04 on 20-Dec-2021, and enrollment into that arm has been completed. Arm 5: Favezelimab + Pembrolizumab and Arm 6: Pembrolizumab + all-trans retinoic acid (ATRA) were added in Amendment 06 on 25-Jun-2022, and enrollment is ongoing.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
146 (actual)
First submitted
9 Mar 2020
Start date
26 Jun 2020
Primary completion date
24 Sept 2025
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
Melanoma
NCT number
NCT04303169
EU CT number
2023-506314-51-00
EudraCT number
2019-003978-22

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 146
  • From 26 Jun 2020 to the primary completion date, 24 Sept 2025
  • 29 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days before the first dose of study intervention
  • Has known hypersensitivity including previous clinically significant hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
  • 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 or live-attenuated 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

Other illness

  • Has a known additional malignancy that is progressing or requires active treatment within the past 2 years
  • 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 known history of hepatitis B
  • Has a history of (noninfectious) pneumonitis
  • Has a history of active tuberculosis (TB)

Other

  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has ocular or mucosal melanoma
  • Has only mucosal lesions
  • Is not naïve to Talimogene laherparepvec (TVEC) and other oncolytic viruses

Who the study is looking for

  • Has histologically or cytologically confirmed melanoma
  • Has clinically detectable and resectable Stage IIIB or IIIC or IIID melanoma amenable to surgery
  • Has been untreated for Stage IIIB, IIIC or IIID melanoma
    • Surgical resection and re-resection of primary melanoma is allowed
    • Prior radiotherapy to the primary melanoma is allowed
  • Has provided a baseline tumor biopsy
  • Male participants who receive gebasaxturev are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 120 days after the last dose of gebasaxturev
  • Male participants who receive all-trans retinoic acid (ATRA) are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of ATRA
  • Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) OR use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after the last dose of pembrolizumab, vibostolimab, gebasaxturev, or MK-4830, favezelimab + pembrolizumab, or 30 days after the last dose of ATRA, whichever occurs last
  • Has adequate organ function
  • Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia)

Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fiona Stanley Hospital ( Site 3401)
Coordinator of this site? Confirm its status
MurdochAustraliaUnknown status
Tasman Oncology Research Pty Ltd ( Site 3403)
Coordinator of this site? Confirm its status
SouthportAustraliaUnknown status
Melanoma Institute Australia ( Site 3402)
Coordinator of this site? Confirm its status
WollstonecraftAustraliaUnknown status
Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 3603)
Coordinator of this site? Confirm its status
GenevaSwitzerlandUnknown status
CHUV Centre Hospitalier Universitaire Vaudois ( Site 3602)
Coordinator of this site? Confirm its status
LausanneSwitzerlandUnknown status
Universitaetsspital Zuerich ( Site 3601)
Coordinator of this site? Confirm its status
Zuerich FlughafenSwitzerlandUnknown status
Assistance Publique Hôpitaux de Marseille
Coordinator of this site? Confirm its status
MarseilleFranceCompleted
Assistance Publique Hopitaux de Paris
Coordinator of this site? Confirm its status
ParisFranceCompleted
Centre Hospitalier Lyon-Sud
Coordinator of this site? Confirm its status
Pierre-BéniteFranceCompleted
Institut Universitaire Du Cancer Toulouse-Oncopole
Coordinator of this site? Confirm its status
Toulouse Cedex 9FranceCompleted
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceCompleted
HaEmek Medical Center ( Site 3703)
Coordinator of this site? Confirm its status
AfulaIsraelUnknown status
Rambam Health Care Campus-Oncology ( Site 3704)
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Hadassah Ein Karem Jerusalem ( Site 3702)
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
Rabin Medical Center-Oncology ( Site 3705)
Coordinator of this site? Confirm its status
Petah TikvaIsraelUnknown status
Chaim Sheba Medical Center ( Site 3701)
Coordinator of this site? Confirm its status
Ramat GanIsraelUnknown status
European Institute Of Oncology S.r.l.
Coordinator of this site? Confirm its status
MilanItalyCompleted
Azienda Ospedaliera Universitaria Senese
Coordinator of this site? Confirm its status
SienaItalyCompleted
University of Colorado, Anschutz Cancer Pavilion ( Site 3012)
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 3022)
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Martha Morehouse Tower ( Site 3020)
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Duke Cancer Institute ( Site 3005)
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
Inova Schar Cancer Institute ( Site 3011)
Coordinator of this site? Confirm its status
FairfaxUnited StatesUnknown status
West Cancer Center - East Campus ( Site 3014)
Coordinator of this site? Confirm its status
GermantownUnited StatesUnknown status
The Angeles Clinic and Research Institute ( Site 3009)
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Los AngelesUnited StatesUnknown status
NYU Clinical Cancer Center ( Site 3002)
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
University of Pennsylvania Abramson Cancer Center ( Site 3008)
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Oregon Health & Science University ( Site 3013)
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
Providence Saint John's Health Center ( Site 3010)
Coordinator of this site? Confirm its status
Santa MonicaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.