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ACTIVE NOT RECRUITING
NCT04835805
PHASE1

A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-mutant Advanced Melanoma.

Sponsor: Genentech, Inc.

View on ClinicalTrials.gov

Summary

This study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus nivolumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.

Official title: A Phase Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-Mutant Advanced Melanoma Who Have Received Anti-PD-1/PD-L1 Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2021-05-13

Completion Date

2027-06-30

Last Updated

2026-03-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

Belvarafenib

Twice daily (BID), continuous dosing

DRUG

Cobimetinib

Once daily (QD) or three times weekly (TIW) for 21 days, 7 days off

DRUG

Nivolumab

Once every 4 weeks (Q4W)

Locations (17)

California Pacific Medical Center Research Institute

San Francisco, California, United States

UCSF Helen Diller Family CCC

San Francisco, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering

New York, New York, United States

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Peter MacCallum Cancer Centre-East Melbourne

Melbourne, Victoria, Australia

Linear Clinical Research Ltd

Nedlands, Western Australia, Australia

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Klinikum Mannheim GmbH Universitätsklinikum

Mannheim, Germany

Universitatsklinikum Tubingen

Tübingen, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

Asan Medical Center - PPDS

Seoul, South Korea