Study on Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab for Treating High-Risk Stage III Melanoma

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03554083

Provider View

This clinical trial is exploring a combination of drugs, including vemurafenib, cobimetinib, atezolizumab, and tiragolumab, to see if they can effectively treat patients with high-risk stage III melanoma. The study aims to find out if these drugs can stop cancer growth and help the immune system attack the cancer.

Patient Parameters

Program Overview

This early phase study is testing how well a combination of drugs works in treating patients with high-risk stage III melanoma. Vemurafenib and cobimetinib may help stop tumor growth by blocking certain enzymes. Atezolizumab and tiragolumab are immunotherapy drugs that may help the immune system fight cancer. The study is looking at whether these drugs, used together, can better treat high-risk stage III melanoma.

Description

The study has several goals:

  • To see how many patients with a specific type of melanoma (BRAFV600 mutation) have no signs of cancer after 12 weeks of treatment with vemurafenib, cobimetinib, and atezolizumab.
  • To see how many patients with another type of melanoma (BRAF wild-type) have no signs of cancer after 12 weeks of treatment with cobimetinib and atezolizumab.
  • To see how many patients with stage III melanoma have no signs of cancer after 12 weeks of treatment with atezolizumab and tiragolumab.
  • To check how long patients stay cancer-free after treatment and surgery.

The study also looks at the safety of these treatments and any side effects they may cause. Researchers will collect tissue, blood, and stool samples to study how the treatments work and their effects on the body.

Participants will be divided into different groups based on their type of melanoma and receive specific treatments. After treatment, they will have surgery and continue with additional therapy to help prevent cancer from returning. The study will follow participants for up to three years to monitor their health and any recurrence of cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have high-risk stage III melanoma, which means the cancer has spread to lymph nodes or other areas.
  • Be willing to provide a tissue sample for testing.
  • Agree not to receive other cancer treatments during the study.
  • Have good blood counts and organ function based on lab tests.
  • Be able to have surgery to remove the cancer.
  • Have a good performance status, meaning they can carry out daily activities with little or no assistance.
  • Agree to use effective birth control during the study and for six months after treatment.
  • Be willing to provide informed consent and follow study procedures.

Exclusion Criteria

  • Have received previous systemic treatment for melanoma, except for certain allowed therapies.
  • Be taking other investigational drugs.
  • Have had major surgery recently or need major surgery during the study.
  • Have a history of other cancers or certain medical conditions that could interfere with the study.
  • Be pregnant or breastfeeding.
  • Have active infections or require certain medications that could affect the study.
  • Have a known allergy to any of the study drugs.
  • Be unable to follow study requirements or attend follow-up visits.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.