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RecruitingLast updated: 15 August 2023

BELVA: This phase I trial is trying to understand the safety and activity of a new targeted therapy drug (belvarafenib) by itself, and in combination with other targeted and immunotherapy drugs, in people with NRAS-mutant advanced melanomaA 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

Clinical summary

Summary

This is a non-randomised trial evaluating three treatment regimens, across three experimental arms. Participants in Experimental Arm 1 will receive Belvarafenib alone, twice daily (BID), continuous dosing. Participants in Experimental Arm 2 will receive Belvarafenib (at the recommended dose) plus cobimetinib once daily (QD) for 21 days, 7 days off. Participants in Experimental Arm 3 will receive Belvarafenib plus cobimetinib (at the recommended dose) plus Atezolizumab once every 4 weeks (Q4W) followed by an expansion phase.

Conditions

This trial is treating patients with melanoma.

Cancer

Skin Cancers Skin

Age

People18+

Phase

I

Trial Acronym

BELVA

More information

Trial Identifiers

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Commercial Sponsor

Genentech, Inc.

Scientific 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

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

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Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.