NCT04835805 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy | SkinMelanoma (Skin)

Trial Overview Read MoreRead more

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 melanoma.
 

This trial is treating patients with melanoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • 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.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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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

Commercial Sponsor

Genentech, Inc.

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.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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