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New hope for hard-to-treat melanoma: drug combo targets NRAS mutation

NCT ID NCT04835805

Disease control Sponsor: Genentech, Inc. 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug called belvarafenib, alone or with other drugs (cobimetinib and nivolumab), in people with advanced melanoma that has a specific NRAS gene change and has stopped responding to standard immunotherapy. The main goals are to check safety and find the right dose. About 65 adults with this type of melanoma will take part.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

65 people

The number who actually took part.

Started

May 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

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 years and older

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: * ECOG Performance Status of 0 or 1 * Histologically confirmed, metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage III) cutaneous melanoma, that has progressed on or after treatment with anti-PD-1 or anti-PD-L1 therapy. Patients may have received up to two lines of systemic cancer therapy. Treatment with anti-PD-1/PD-L1 in the adjuvant setting is acceptable. Patients must have progressed disease at study entry * Documentation of NRAS mutation-positive within 5 years prior to screening * Tumor specimen availability * Adequate hematologic and end-organ function * Measurable disease per RECIST v1.1 Exclusion Criteria: * Prior treatment with a pan-RAF inhibitor * Treatment with systemic immunotherapy agents (e.g., anti-CTLA4, anti-PD(L)1, cytokine therapy, investigational therapy, etc.) within 28 days prior to C1D1 * Symptomatic, untreated, or actively progressing CNS metastases * History or signs/symptoms of clinically significant cardiovascular disease * Known clinically significant liver disease * History of autoimmune disease or immune deficiency * Prior treatment with a MEK inhibitor (cobimetinib arm) * History of or evidence of retinal pathology on ophthalmologic examination (cobimetinib arm) * History of immune-related AE attributed to prior anti-PD(L)1 therapy that resulted in permanent discontinuation of anti-PD(L)1 therapy (nivolumab arm)

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

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

Melanoma

Contacts and locations

Locations

  • Asan Medical Center - PPDS

    Seoul, 05505, South Korea

  • California Pacific Medical Center Research Institute

    San Francisco, California, 94115, United States

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Charité - Universitätsmedizin Berlin

    Berlin, 12203, Germany

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231, United States

  • Klinikum Mannheim GmbH Universitätsklinikum

    Mannheim, 68167, Germany

  • Linear Clinical Research Ltd

    Nedlands, Western Australia, 6009, Australia

  • Memorial Sloan Kettering

    New York, New York, 10021, United States

  • Ottawa Hospital Regional Cancer Centre

    Ottawa, Ontario, K1H 8M2, Canada

  • Peter MacCallum Cancer Centre-East Melbourne

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

  • Samsung Medical Center - PPDS

    Seoul, 06351, South Korea

  • UCSF Helen Diller Family CCC

    San Francisco, California, 94158, United States

  • Universitatsklinikum Tubingen

    Tübingen, 72076, Germany

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045, United States

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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