A Phase IB Study of Belvarafenib Alone and in Combination with Cobimetinib in People with Advanced Melanoma Who Had Immunotherapy

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Full 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

Purpose

The purpose of this study is to find the highest dose of the investigational drug belvarafenib that can be given safely alone and with cobimetinib in people with advanced NRAS-mutated melanoma that continues to grow despite prior treatment with immunotherapy. In earlier studies, belvarafenib was shown to stop the growth of cancer cells in advanced NRAS-mutant melanoma.

Cobimetinib belongs to a class of anticancer drugs that work against cancer by blocking a protein called MEK. It is already used to treat advanced melanoma. Its use in this study with belvarafenib is considered investigational. Patients in this study will receive belvarafenib alone or belvarafenib plus cobimetinib. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have NRAS-mutated inoperable or metastatic melanoma that continues to grow despite prior treatment with PD-1 inhibitor immunotherapy, such as nivolumab or pembrolizumab.
  • At least 4 weeks must pass between the completion of prior immunotherapy and receipt of the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Paul Chapman at 646-888-4162.

Protocol

21-254

Phase

I

Investigator

Co-Investigators