Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

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 Atezolizumab in Patients With NRAS-Mutant Advanced Melanoma Who Have Received Anti-PD-1/PD-L1 Therapy

Details

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.

Keywords

Melanoma Atezolizumab Belvarafenib Cobimetinib Belvarafenib Monotherapy Belvarafenib Plus cobimetinib Belvarafenib Plus Cobimetinib Plus Atezolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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)

Locations

  • UCSF Helen Diller Family CCC
    San Francisco California 94158 United States
  • California Pacific Medical Center Research Institute
    San Francisco California 94115 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Genentech, Inc.
ID
NCT04835805
Phase
Phase 1
Study Type
Interventional
Last Updated