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.

Part of paid clinical trials in San Francisco, California.

Sponsor
Genentech, Inc.
Study ID
NCT04835805
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belvarafenib — DRUG
    Twice daily (BID), continuous dosing
  • Cobimetinib — DRUG
    Once daily (QD) or three times weekly (TIW) for 21 days, 7 days off
  • Nivolumab — DRUG
    Once every 4 weeks (Q4W)

Study Details

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.

Key Dates

Start date
May 13, 2021
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
65 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Belvarafenib Monotherapy
    Twice daily (BID), continuous dosing.
  • Experimental: Belvarafenib Plus Cobimetinib
    Recommended dose (RD) and schedule of belvarafenib and cobimetinib selected based on the safety data, tolerability, pharmacokinetics, and anti-tumor activity tested in dose-finding phase followed by an expansion phase.
  • Experimental: Belvarafenib Plus Cobimetinib Plus Nivolumab
    Recommended dose (RD) and schedule of belvarafenib and cobimetinib plus nivolumab IV infusion every 4 weeks (Q4W) in a run-in phase followed by an expansion phase

Primary Outcome Measure

Percentage of Participants With Dose Limiting Toxicity (DLTs) [ Time Frame: 28 Days from Cycle 1, Day 1 ]

Locations (6)

FacilityCityStateZIPSite coordinators
California Pacific Medical Center Research InstituteSan FranciscoCalifornia94115-
UCSF Helen Diller Family CCCSan FranciscoCalifornia94158-
University of Colorado Cancer CenterAuroraColorado80045-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21231-
Washington University School of MedicineSt LouisMissouri63110-
Memorial Sloan KetteringNew YorkNew York10021-

Find similar trials in San Francisco, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
California Pacific Medical Center Research Institute· San Francisco, CAUCSF Helen Diller Family CCC· San Francisco, CAUniversity of Colorado Cancer Center· Aurora, COJohns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDWashington University School of Medicine· St Louis, MOMemorial Sloan Kettering· New York, NY

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