MelanomaPhase 1/2NCT04305054
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)
A Phase 1/2 study testing Pembrolizumab, Vibostolimab and Pembrolizumab/Quavonlimab in people with Melanoma, run by Merck Sharp & Dohme LLC at 60 sites in 14 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Melanoma
- What is being tested?
- Pembrolizumab, Vibostolimab and Pembrolizumab/Quavonlimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 60 sitesin 14 countries
- Study dates
- 1 Jul 2020to 18 May 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
60 sites in 14 countries.
60 sites in 14 countries
United States15 sites
University of Colorado, Anschutz Cancer Pavilion ( Site 2012)
Aurora, Colorado, 80045
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 2022)
Baltimore, Maryland, 21287
Martha Morehouse Tower ( Site 2020)
Columbus, Ohio, 43221
Duke Cancer Institute ( Site 2005)
Durham, North Carolina, 27710
Inova Schar Cancer Institute ( Site 2011)
Fairfax, Virginia, 22031
University of Florida College of Medicine-UF Health Cancer Center/Clinical Trials Office ( Site 2026)
Gainesville, Florida, 32608
West Cancer Center - East Campus ( Site 2014)
Germantown, Tennessee, 38138
R.J. Zuckerberg Cancer Center ( Site 2032)
Lake Success, New York, 11042
The Angeles Clinic and Research Institute ( Site 2009)
Los Angeles, California, 90025
UCLA Hematology & Oncology ( Site 2004)
Los Angeles, California, 90095
NYU Clinical Cancer Center ( Site 2002)
New York, New York, 10016
University of Pennsylvania Abramson Cancer Center ( Site 2008)
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University ( Site 2013)
Portland, Oregon, 97239
Mays Cancer Center ( Site 2025)
San Antonio, Texas, 78229
Providence Saint John's Health Center ( Site 2010)
Santa Monica, California, 90404
France6 sites
CHU de Bordeaux- Hopital Saint Andre ( Site 2108)
Bordeaux, Gironde, 33075
Hopital La Timone ( Site 2103)
Marseille, Bouches-du-Rhone, 13005
A.P.H. Paris, Hopital Saint Louis ( Site 2107)
Paris, 75010
C.H. Lyon Sud ( Site 2102)
Pierre-Bénite, Rhone, 69495
Institut Claudius Regaud ( Site 2105)
Toulouse, Haute-Garonne, 31059
Gustave Roussy ( Site 2101)
Villejuif, Île-de-France Region, 94805
Chile5 sites
IC La Serena Research ( Site 2254)
La Serena, Coquimbo Region, 1720430
FALP-UIDO ( Site 2251)
Santiago, Region M. de Santiago, 7500921
Oncovida ( Site 2257)
Santiago, Region M. de Santiago, 7500994
Bradfordhill ( Site 2252)
Santiago, Region M. de Santiago, 8420383
CIDO SpA-Oncology ( Site 2256)
Temuco, Araucania, 4810218
Israel5 sites
HaEmek Medical Center ( Site 2703)
Afula, 1834111
Rambam Health Care Campus-Oncology ( Site 2704)
Haifa, 3109601
Hadassah Ein Karem Jerusalem ( Site 2702)
Jerusalem, 9112001
Rabin Medical Center-Oncology ( Site 2705)
Petah Tikva, 4941492
Chaim Sheba Medical Center ( Site 2701)
Ramat Gan, 5265601
Italy5 sites
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2399)
Milan, 20133
Istituto Europeo di Oncologia ( Site 2301)
Milan, 20141
Istituto Nazionale Tumori Fondazione Pascale ( Site 2302)
Naples, 80131
Istituto Oncologico Veneto IRCCS ( Site 2355)
Padova, 35128
Policlinico Le Scotte - A.O. Senese ( Site 2377)
Siena, 53100
South Africa5 sites
Cape Town Oncology Trials ( Site 2864)
Cape Town, Western Cape, 7570
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2865)
Port Elizabeth, Eastern Cape, 6055
Steve Biko Academic Hospital-Medical Oncology ( Site 2862)
Pretoria, Gauteng, 0002
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 2861)
Pretoria, Gauteng, 0181
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2863)
Sandton, Gauteng, 2196
Australia4 sites
Fiona Stanley Hospital ( Site 2401)
Murdoch, Western Australia, 6150
Tasman Oncology Research Pty Ltd ( Site 2403)
Southport, Queensland, 4120
Calvary Mater Newcastle-Medical Oncology ( Site 2404)
Waratah, New South Wales, 2298
Melanoma Institute Australia ( Site 2402)
Wollstonecraft, New South Wales, 2065
Argentina3 sites
Instituto Alexander Fleming-Alexander Fleming ( Site 2243)
Buenos Aires, Buenos Aires F.D., 1426ANZ
Sanatorio Finochietto ( Site 2245)
Buenos Aires, C1187AAN
Clinica Adventista Belgrano-Oncology ( Site 2242)
Caba., Buenos Aires, C1430EGF
Switzerland3 sites
Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 2603)
Geneva, Canton of Geneva, 1211
CHUV Centre Hospitalier Universitaire Vaudois ( Site 2602)
Lausanne, Canton of Vaud, 1011
Universitaetsspital Zuerich ( Site 2601)
Zuerich Flughafen, Canton of Zurich, 8058
Colombia2 sites
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 2261)
Bogotá, Bogota D.C., 111321
Fundación Valle del Lili ( Site 2265)
Cali, Valle del Cauca Department, 760032
Greece2 sites
General Hospital of Athens "Laiko"-First Department of Internal Medicine ( Site 2212)
Athens, Attica, 115 26
European Interbalkan Medical Center-Oncology Department ( Site 2211)
Thessaloniki, 570 01
Poland2 sites
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2231)
Gdansk, Pomeranian Voivodeship, 80-952
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2233)
Warsaw, Masovian Voivodeship, 02-781
Spain2 sites
HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 2801)
Barcelona, Catalonia, 08036
Hospital Universitario Ramón y Cajal ( Site 2802)
Madrid, Madrid, Comunidad de, 28034
Hungary1 site
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 2221)
Szeged, Csongrád megye, 6720
About this study
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
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
Read the detailed description
With Amendment 6, all arms are closed to enrollment. Participants in arms 2 (pembrolizumab), 3 (coformulation pembrolizumab/quavonlimab), and 4 (coformulation pembrolizumab/quavonlimab + lenvatinib) who complete study treatment or otherwise meet end of treatment (EOT) criteria will be discontinued from the study after completing the EOT visit and any required safety follow-up visits. Participants in arm 6 (coformulation favezelimab/pembrolizumab + All-trans Retinoic Acid [ATRA]) will discontinue ATRA and participants in arms 5 and 6 can continue on coformulation favezelimab/pembrolizumab or pembrolizumab.
- Conditions
- Melanoma
- Being tested
- Pembrolizumab, Vibostolimab, Pembrolizumab/Quavonlimab, Lenvatinib, Favezelimab/Pembrolizumab
- Keywords
- 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)
- Medical subject headings
- Melanoma, Parkinson Disease 4, Autosomal Dominant Lewy Body, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabBiological
Also called MK-3475, KEYTRUDA®
Administered via IV infusion at a specified dose on specified days
VibostolimabBiological
Also called MK-7684
Administered via IV infusion at a specified dose on specified days
Pembrolizumab/QuavonlimabBiological
Also called MK-1308A
Administered via IV infusion at a specified dose on specified days
LenvatinibDrug
Also called MK-7902, E7080, LENVIMA®
Administered via oral capsule at a specified dose on specified days
Favezelimab/PembrolizumabBiological
Also called MK-4280A
Administered via IV infusion at a specified dose on specified days
ATRADrug
Administered via oral capsule at a specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Vibostolimab | Experimental | 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. Receives: Biological: Pembrolizumab; Biological: Vibostolimab |
| Pembrolizumab | Active comparator | Participants will receive pembrolizumab IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years. Receives: Biological: Pembrolizumab |
| Coformulation Pembrolizumab/Quavonlimab | Experimental | 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. Receives: Biological: Pembrolizumab; Biological: Pembrolizumab/Quavonlimab |
| Coformulation Pembrolizumab/Quavonlimab + Lenvatinib | Experimental | 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. Receives: Biological: Pembrolizumab; Biological: Pembrolizumab/Quavonlimab; Drug: Lenvatinib |
| Coformulation Favezelimab/Pembrolizumab | Experimental | 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 Receives: Biological: Favezelimab/Pembrolizumab |
| Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA) | Experimental | 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). Receives: Drug: ATRA |
| Coformulation Favezelimab/Pembrolizumab + Vibostolimab | Experimental | 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. Receives: Biological: Vibostolimab; Biological: Favezelimab/Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who experience a dose-limiting toxicity (DLT): Safety lead-in phase
The percentage of participants who experience 1 or more protocol-defined DLTs during the safety lead-in period will be reported.
Measured: Up to ~3 weeks
Percentage of participants who experience an adverse event (AE): Safety lead-in
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.
Measured: Up to ~3 weeks
Percentage of participants who discontinue study treatment due to an AE: Safety lead-in
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.
Measured: Up to ~3 weeks
Percentage of participants who experience an adverse event (AE)
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.
Measured: Up to ~28 months
Percentage of participants who discontinue study treatment due to an AE
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.
Measured: Up to ~24 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
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.
Measured: Up to ~30 months
Secondary outcomes (1)
Duration of Response (DOR) per RECIST 1.1
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.
Measured: Up to ~30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Jul 2020
- Primary completion18 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305054
- Sponsor's protocol ID
- 3475-02B
- Other IDs
- MK-3475-02B, KEYMAKER-U02, 2023-506313-21-00, U1111-1293-5644, 2019-003977-24, 2019, 2023
- Status last verified
- May 2026
- First submitted
- 9 Mar 2020
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04305054
- Acronym / sponsor ID
- 3475-02B
- Conditions
- Melanoma
- Keywords
- 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)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
With Amendment 6, all arms are closed to enrollment. Participants in arms 2 (pembrolizumab), 3 (coformulation pembrolizumab/quavonlimab), and 4 (coformulation pembrolizumab/quavonlimab + lenvatinib) who complete study treatment or otherwise meet end of treatment (EOT) criteria will be discontinued from the study after completing the EOT visit and any required safety follow-up visits. Participants in arm 6 (coformulation favezelimab/pembrolizumab + All-trans Retinoic Acid [ATRA]) will discontinue ATRA and participants in arms 5 and 6 can continue on coformulation favezelimab/pembrolizumab or pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + Vibostolimab | Experimental | Biological: Pembrolizumab, Biological: VibostolimabParticipants 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. |
| Pembrolizumab | Active comparator | Biological: PembrolizumabParticipants will receive pembrolizumab IV at a specified dose on specified days for a total treatment duration of up to approximately 2 years. |
| Coformulation Pembrolizumab/Quavonlimab | Experimental | Biological: Pembrolizumab, Biological: Pembrolizumab/QuavonlimabParticipants 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. |
| Coformulation Pembrolizumab/Quavonlimab + Lenvatinib | Experimental | Biological: Pembrolizumab, Biological: Pembrolizumab/Quavonlimab, Drug: LenvatinibParticipants 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. |
| Coformulation Favezelimab/Pembrolizumab | Experimental | Biological: Favezelimab/PembrolizumabParticipants 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 |
| Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA) | Experimental | Drug: ATRAParticipants 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). |
| Coformulation Favezelimab/Pembrolizumab + Vibostolimab | Experimental | Biological: Vibostolimab, Biological: Favezelimab/PembrolizumabParticipants 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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):
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: MK-3475, KEYTRUDA®Administered via IV infusion at a specified dose on specified days | Biological | Coformulation Pembrolizumab/Quavonlimab, Coformulation Pembrolizumab/Quavonlimab + Lenvatinib, Pembrolizumab, Pembrolizumab + Vibostolimab |
| VibostolimabAlso: MK-7684Administered via IV infusion at a specified dose on specified days | Biological | Coformulation Favezelimab/Pembrolizumab + Vibostolimab, Pembrolizumab + Vibostolimab |
| Pembrolizumab/QuavonlimabAlso: MK-1308AAdministered via IV infusion at a specified dose on specified days | Biological | Coformulation Pembrolizumab/Quavonlimab, Coformulation Pembrolizumab/Quavonlimab + Lenvatinib |
| LenvatinibAlso: MK-7902, E7080, LENVIMA®Administered via oral capsule at a specified dose on specified days | Drug | Coformulation Pembrolizumab/Quavonlimab + Lenvatinib |
| Favezelimab/PembrolizumabAlso: MK-4280AAdministered via IV infusion at a specified dose on specified days | Biological | Coformulation Favezelimab/Pembrolizumab, Coformulation Favezelimab/Pembrolizumab + Vibostolimab |
| ATRAAdministered via oral capsule at a specified dose on specified days | Drug | Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA) |
Primary outcome
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.
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.
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.
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.
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.
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.
1 secondary outcome
Duration of Response (DOR) per RECIST 1.1
Time frame: Up to ~30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
60 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pembrolizumab, Vibostolimab and Pembrolizumab/Quavonlimab in people with Melanoma, run by Merck Sharp & Dohme LLC at 60 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, France, Chile, Israel, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who experience a dose-limiting toxicity (DLT): Safety lead-in phase (time frame: Up to ~3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.