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
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fiona Stanley Hospital ( Site 3401) Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Tasman Oncology Research Pty Ltd ( Site 3403) Coordinator of this site? Confirm its status | Southport | Australia | Unknown status |
| Melanoma Institute Australia ( Site 3402) Coordinator of this site? Confirm its status | Wollstonecraft | Australia | Unknown status |
| Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 3603) Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
| CHUV Centre Hospitalier Universitaire Vaudois ( Site 3602) Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Universitaetsspital Zuerich ( Site 3601) Coordinator of this site? Confirm its status | Zuerich Flughafen | Switzerland | Unknown status |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Completed |
| Institut Universitaire Du Cancer Toulouse-Oncopole Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| HaEmek Medical Center ( Site 3703) Coordinator of this site? Confirm its status | Afula | Israel | Unknown status |
| Rambam Health Care Campus-Oncology ( Site 3704) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Ein Karem Jerusalem ( Site 3702) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Rabin Medical Center-Oncology ( Site 3705) Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Chaim Sheba Medical Center ( Site 3701) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| European Institute Of Oncology S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliera Universitaria Senese Coordinator of this site? Confirm its status | Siena | Italy | Completed |
| University of Colorado, Anschutz Cancer Pavilion ( Site 3012) Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 3022) Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Martha Morehouse Tower ( Site 3020) Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Duke Cancer Institute ( Site 3005) Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Inova Schar Cancer Institute ( Site 3011) Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| West Cancer Center - East Campus ( Site 3014) Coordinator of this site? Confirm its status | Germantown | United States | Unknown status |
| The Angeles Clinic and Research Institute ( Site 3009) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| NYU Clinical Cancer Center ( Site 3002) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pennsylvania Abramson Cancer Center ( Site 3008) Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Oregon Health & Science University ( Site 3013) Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Providence Saint John's Health Center ( Site 3010) Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.