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Can new drug cocktails reawaken the immune system against melanoma?

NCT ID NCT04305041

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Sep 02, 2026 · Updated 3 times

Summary

This trial is testing whether combining the immunotherapy drug pembrolizumab with other experimental agents can help people with advanced melanoma whose cancer has stopped responding to standard anti-PD-1 treatment. The study includes several treatment arms, each pairing pembrolizumab with a different drug, such as quavonlimab, vibostolimab, lenvatinib, or ATRA. The goal is to see if any of these combinations can shrink tumors and improve outcomes, while also monitoring safety and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Combinations of pembrolizumab with quavonlimab, vibostolimab, lenvatinib, or ATRA
What this could lead to
If successful, these combinations could offer new treatment options for people with advanced melanoma that no longer responds to current immunotherapies.
What could go wrong
This is an early-phase trial, so the combinations may not prove more effective than existing treatments and could cause additional side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

100 people

The number who actually took part.

Started

Jun 2020

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 120 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has histologically or cytologically confirmed melanoma * Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy * Has progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies * Has imaging documenting progression per RECIST 1.1 and iRECIST after initiation of an anti-PD-1/L1 agent, or by RECIST 1.1 if progression occurred on adjuvant therapy or in the setting of rapid progression. * Has not received more than 3 lines of therapy for their advanced melanoma * Has provided a tumor biopsy * Male participants who receive lenvatinib or 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 lenvatinib or ATRA; for male participants who only receive pembrolizumab, quavonlimab, vibostolimab, or a combination, no contraception measures are needed * Female participant 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, quavonlimab, vibostolimab or 30 days after the last dose of lenvatinib or 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) Exclusion Criteria: * 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 known hypersensitivity including previous clinically significant hypersensitivity reaction to treatment with another mAb * 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) * 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 pre-existing Grade ≥3 gastrointestinal fistula or nongastrointestinal fistula * Has radiographic evidence of encasement of invasion of 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

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

Contacts and locations

Locations

  • A.P.H. Paris, Hopital Saint Louis ( Site 1107)

    Paris, 75010, France

  • CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 1865)

    Port Elizabeth, Eastern Cape, 6055, South Africa

  • CHUV Centre Hospitalier Universitaire Vaudois ( Site 1602)

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Calvary Mater Newcastle-Medical Oncology ( Site 1404)

    Waratah, New South Wales, 2298, Australia

  • Centre Hospitalier Lyon Sud ( Site 1102)

    Pierre-Bénite, Rhone, 69495, France

  • Chaim Sheba Medical Center ( Site 1701)

    Ramat Gan, 5265601, Israel

  • Duke Cancer Institute ( Site 1005)

    Durham, North Carolina, 27710, United States

  • Fiona Stanley Hospital ( Site 1401)

    Murdoch, Western Australia, 6150, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1399)

    Milan, 20133, Italy

  • Gustave Roussy ( Site 1101)

    Villejuif, Île-de-France Region, 94805, France

  • HaEmek Medical Center ( Site 1703)

    Afula, 1834111, Israel

  • Hadassah Ein Karem Jerusalem ( Site 1702)

    Jerusalem, 9112001, Israel

  • Hopital La Timone ( Site 1103)

    Marseille, Bouches-du-Rhone, 13005, France

  • Hopital Saint Andre ( Site 1108)

    Bordeaux, Gironde, 33075, France

  • Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1603)

    Geneva, Canton of Geneva, 1211, Switzerland

  • Inova Schar Cancer Institute ( Site 1011)

    Fairfax, Virginia, 22031, United States

  • Institut Claudius Regaud ( Site 1105)

    Toulouse, Haute-Garonne, 31059, France

  • Istituto Europeo di Oncologia ( Site 1301)

    Milan, 20141, Italy

  • Istituto Nazionale Tumori Fondazione Pascale ( Site 1302)

    Naples, 80131, Italy

  • Istituto Oncologico Veneto IRCCS ( Site 1355)

    Padova, 35128, Italy

  • Martha Morehouse Tower ( Site 1020)

    Columbus, Ohio, 43221, United States

  • Melanoma Institute Australia ( Site 1402)

    Wollstonecraft, New South Wales, 2065, Australia

  • NYU Clinical Cancer Center ( Site 1002)

    New York, New York, 10016, United States

  • Oregon Health & Science University ( Site 1013)

    Portland, Oregon, 97239, United States

  • Policlinico Le Scotte - A.O. Senese ( Site 1377)

    Siena, 53100, Italy

  • Providence Saint John's Health Center ( Site 1010)

    Santa Monica, California, 90404, United States

  • Rambam Health Care Campus-Oncology ( Site 1704)

    Haifa, 3109601, Israel

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1022)

    Baltimore, Maryland, 21287, United States

  • Tasman Oncology Research Pty Ltd ( Site 1403)

    Southport, Queensland, 4215, Australia

  • The Angeles Clinic and Research Institute ( Site 1009)

    Los Angeles, California, 90025, United States

  • UCLA Hematology & Oncology ( Site 1004)

    Los Angeles, California, 90095, United States

  • Universitaetsspital Zuerich ( Site 1601)

    Zuerich Flughafen, Canton of Zurich, 8058, Switzerland

  • University of Colorado, Anschutz Cancer Pavilion ( Site 1012)

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania Abramson Cancer Center ( Site 1008)

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas MD Anderson Cancer Center ( Site 1006)

    Houston, Texas, 77030, United States

  • West Cancer Center - East Campus ( Site 1014)

    Germantown, Tennessee, 38138, United States

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