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New combo therapy shows promise for advanced melanoma

NCT ID NCT03815058

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether adding a personalized cancer vaccine (RO7198457) to the immunotherapy drug pembrolizumab works better than pembrolizumab alone for people with advanced melanoma that hasn't been treated before. The trial involved 131 participants and measured how long the cancer stayed under control. The goal is to improve treatment options for this serious skin cancer.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

131 people

The number who actually took part.

Started

Dec 2018

Finished

Jan 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 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: * Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma; * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; * Life expectancy \>/= 12 weeks; * Adequate hematologic and end-organ function; * Naive to prior systemic anti-cancer therapy for advanced melanoma with some exceptions; * Tumor specimen availability; * Measurable disease per RECIST v1.1. Exclusion criteria: * Ocular/uveal melanoma; * Any anti-cancer therapy with the exceptions as specified in the protocol; * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases; * Previous splenectomy; * History of autoimmune disease; * Prior allogeneic bone marrow transplantation or prior solid organ transplantation; * Positive test for Human Immunodeficiency Virus (HIV) infection; * Active hepatitis B or C or tuberculosis; * Significant cardiovascular disease; * Known clinically significant liver disease.

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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.

Advanced melanoma

Contacts and locations

Locations

  • Alfred Hospital

    Melbourne, Victoria, 3181, Australia

  • Antwerp University Hospital

    Edegem, 2650, Belgium

  • Atlanta Cancer Care

    Alpharetta, Georgia, 30005, United States

  • Barts and The London

    London, EC1M 6BQ, United Kingdom

  • Cancer Specialists

    Jacksonville, Florida, 32256, United States

  • Case Western Research University

    Cleveland, Ohio, 44106-5067, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Elbe Kliniken Stade-Buxtehude GmbH

    Buxtehude, 21614, Germany

  • Fachklinik Hornheide

    Münster, 48157, Germany

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Universitario La Paz

    Madrid, 280146, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Instituto Oncológico Dr. Rosell

    Barcelona, 08028, Spain

  • Intermountain Surgical Oncology

    Murray, Utah, 84107, United States

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Massachusetts General Hospital.

    Boston, Massachusetts, 02114, United States

  • Med. Fakultat Mannheim der Universitat Heidelberg

    Mannheim, 68167, Germany

  • Moffitt McKinley Outpatient Center

    Tampa, Florida, 33612, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • St. John of God - Subiaco Hospital

    Subiaco, Western Australia, 6008, Australia

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011, Australia

  • UCSF Comprehensive Cancer Ctr

    San Francisco, California, 94115, United States

  • Uni Schleswig-Holstein

    Lübeck, 23562, Germany

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik

    Mainz, 55131, Germany

  • Universitatsklinikum Eppendorf

    Hamburg, 20246, Germany

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92037, United States

  • University of Colorado

    Denver, Colorado, 80262, United States

  • University of Virginia

    Charlottesville, Virginia, 22906, United States

  • Universitätshautk. Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Koeln

    Cologne, 50937, Germany

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035, Spain

  • Washington University

    St Louis, Missouri, 63110, United States

  • ZAS Sint Augustinus Wilrijk

    Wilrijk, 2610, Belgium

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