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Melanoma trial mixes keytruda with new drugs to boost Pre-Surgery results

NCT ID NCT04303169

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tested several combinations of the immunotherapy drug pembrolizumab (Keytruda) with other experimental drugs in people with stage III melanoma that can be surgically removed. The goal was to see if these combinations are safe and more effective than current treatments at eliminating cancer before surgery. About 146 participants were enrolled across different treatment arms, and the study is now complete.

What this could mean

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

Active substance
Pembrolizumab (Keytruda) combined with other drugs (vibostolimab, gebasaxturev, MK-4830, favezelimab, or ATRA)
What this could lead to
If successful, this could point toward better pre-surgery treatment options for stage III melanoma, potentially improving tumor clearance and long-term outcomes.
What could go wrong
This is an early-phase trial with small groups, so results may not apply broadly. Side effects from the drug combinations are possible, and not all arms may prove superior to current care.

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

146 people

The number who actually took part.

Started

Jun 2020

Finished

Sep 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 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) 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 monoclonal antibody (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 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 * Has only mucosal lesions * Is not naïve to Talimogene laherparepvec (TVEC) and other oncolytic viruses

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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 3107)

    Paris, 75010, France

  • CHUV Centre Hospitalier Universitaire Vaudois ( Site 3602)

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Centre Hospitalier Lyon Sud ( Site 3102)

    Pierre-Bénite, Rhone, 69495, France

  • Chaim Sheba Medical Center ( Site 3701)

    Ramat Gan, 5265601, Israel

  • Duke Cancer Institute ( Site 3005)

    Durham, North Carolina, 27710, United States

  • Fiona Stanley Hospital ( Site 3401)

    Murdoch, Western Australia, 6150, Australia

  • Gustave Roussy ( Site 3101)

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

  • HaEmek Medical Center ( Site 3703)

    Afula, 1834111, Israel

  • Hadassah Ein Karem Jerusalem ( Site 3702)

    Jerusalem, 9112001, Israel

  • Hopital La Timone ( Site 3103)

    Marseille, Bouches-du-Rhone, 13005, France

  • Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 3603)

    Geneva, Canton of Geneva, 1211, Switzerland

  • Inova Schar Cancer Institute ( Site 3011)

    Fairfax, Virginia, 22031, United States

  • Institut Claudius Regaud ( Site 3105)

    Toulouse, Haute-Garonne, 31059, France

  • Istituto Europeo di Oncologia ( Site 3301)

    Milan, 20141, Italy

  • Martha Morehouse Tower ( Site 3020)

    Columbus, Ohio, 43221, United States

  • Melanoma Institute Australia ( Site 3402)

    Wollstonecraft, New South Wales, 2065, Australia

  • NYU Clinical Cancer Center ( Site 3002)

    New York, New York, 10016, United States

  • Oregon Health & Science University ( Site 3013)

    Portland, Oregon, 97239, United States

  • Policlinico Le Scotte - A.O. Senese ( Site 3377)

    Siena, 53100, Italy

  • Providence Saint John's Health Center ( Site 3010)

    Santa Monica, California, 90404, United States

  • Rabin Medical Center-Oncology ( Site 3705)

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus-Oncology ( Site 3704)

    Haifa, 3109601, Israel

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 3022)

    Baltimore, Maryland, 21287, United States

  • Tasman Oncology Research Pty Ltd ( Site 3403)

    Southport, Queensland, 4215, Australia

  • The Angeles Clinic and Research Institute ( Site 3009)

    Los Angeles, California, 90025, United States

  • Universitaetsspital Zuerich ( Site 3601)

    Zuerich Flughafen, Canton of Zurich, 8058, Switzerland

  • University of Colorado, Anschutz Cancer Pavilion ( Site 3012)

    Aurora, Colorado, 80045, United States

  • University of Pennsylvania Abramson Cancer Center ( Site 3008)

    Philadelphia, Pennsylvania, 19104, United States

  • West Cancer Center - East Campus ( Site 3014)

    Germantown, Tennessee, 38138, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.