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.

  • Melanoma
Trial Status:

Recruiting

This trial runs in
Countries
  • Australia
  • Canada
  • Germany
  • Norway
  • South Korea
  • United States
Trial Identifier:

NCT04835805 2020-003674-41 GO42273

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial 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.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT04835805 , GO42273 , 2020-003674-41 Trial Identifier
      Belvarafenib, Cobimetinib, Atezolizumab Treatments
      Melanoma Condition
      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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      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)

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