Melanoma Clinical Trial

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

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 atezolizumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.

View Full Description

Full Description

The study will evaluate three treatment regimens in three arms: a belvarafenib monotherapy arm (Belva arm) of up to 15 patients; a belvarafenib plus cobimetinib arm (Belva + Cobi arm) in an initial dose-finding phase followed by an expansion phase and a belvarafenib plus cobimetinib plus atezolizumab arm (Belva + Cobi + Atezo arm) in a run-in phase followed by an expansion phase.

View Eligibility Criteria

Eligibility Criteria

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 progressive 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:

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 (atezolizumab arm)

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

98

Study ID:

NCT04835805

Recruitment Status:

Recruiting

Sponsor:

Genentech, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 24 Locations for this study

See Locations Near You

Chao Family Comprehensive Cancer Center UCI
Orange California, 92868, United States
California Pacific Medical Center Research Institute
San Francisco California, 94115, United States
UCSF Helen Diller Family CCC
San Francisco California, 94158, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
University of Iowa
Iowa City Iowa, 52242, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore Maryland, 21287, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Memorial Sloan Kettering
New York New York, 10065, United States
Tennessee Oncology, PLLC - SCRI - PPDS
Nashville Tennessee, 37203, United States
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia
Peter MacCallum Cancer Centre-East Melbourne
Melbourne Victoria, 3000, Australia
Linear Clinical Research Ltd
Nedlands Western Australia, 6009, Australia
Ottawa Hospital Regional Cancer Centre
Ottawa Ontario, K1H 8, Canada
Princess Margaret Hospital; Department of Med Oncology
Toronto Ontario, M5G 2, Canada
The Sir Mortimer B. Davis General Hospital
Montreal Quebec, H3T 1, Canada
Charité - Universitätsmedizin Berlin
Berlin , 10117, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg , 20246, Germany
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim , 68167, Germany
Universitätsklinikum Tübingen
Tübingen , 72076, Germany
Universitätsklinikum Würzburg
Würzburg , 97080, Germany
Asan Medical Center - PPDS
Seoul , 05505, Korea, Republic of
Samsung Medical Center - PPDS
Seoul , 06351, Korea, Republic of
Haukeland Universitetssykehus
Bergen , 5021, Norway
Oslo universitetssykehus HF
Oslo , 0379, Norway

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

98

Study ID:

NCT04835805

Recruitment Status:

Recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.