Study on Bevacizumab and Atezolizumab With or Without Cobimetinib for Treating Untreated Melanoma Brain Metastases

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03175432

Provider View

This clinical trial is exploring how well the combination of drugs bevacizumab and atezolizumab, with or without cobimetinib, works in treating patients with melanoma that has spread to the brain and has not been treated yet.

Patient Parameters

Program Overview

This study aims to find out if using the drugs bevacizumab and atezolizumab, with or without cobimetinib, can effectively treat melanoma that has spread to the brain. Bevacizumab and atezolizumab are monoclonal antibodies that may help stop tumor cells from growing and spreading. Cobimetinib may block certain enzymes needed for tumor growth. The study will compare the effectiveness of these treatments in patients with untreated melanoma brain metastases.

Description

The main goals of this study are to see how well the combination of bevacizumab and atezolizumab works in shrinking brain tumors in patients with melanoma and to assess the safety and effectiveness of adding cobimetinib to this combination.

Patients will be divided into two groups:

  • Group 1: Will receive bevacizumab and atezolizumab through an IV every 14 days.
  • Group 2: Will receive bevacizumab and atezolizumab through an IV every 14 days, and cobimetinib orally for 21 days in a 28-day cycle.

The study will monitor the response of brain tumors to these treatments, the safety and side effects of the drugs, and the overall health and quality of life of the participants. After completing the treatment, patients will have follow-up visits every three months to check their progress.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be able to understand and agree to the study requirements.
  • Must have a life expectancy of more than 12 weeks.
  • Must have untreated melanoma that has spread to the brain.
  • Must not have symptoms from brain metastases or be on a stable dose of steroids.
  • Must have had previous treatments for melanoma outside the brain, but not with PD-1/PD-L1 inhibitors.
  • Must have at least one measurable brain tumor that meets specific size criteria.
  • Must provide a tumor sample for testing.
  • Must have good blood counts and organ function as determined by specific tests.
  • Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during and after the study.
  • Must have an ECOG performance status of 0 to 2, indicating good overall health.

Exclusion Criteria

  • Must not have symptomatic brain metastases requiring immediate treatment.
  • Must not have had recent cancer treatments or be participating in another drug study.
  • Must not have unresolved side effects from previous cancer treatments.
  • Must not have significant liver disease or other serious health conditions.
  • Must not be pregnant or breastfeeding.
  • Must not have a history of severe allergic reactions to similar drugs.
  • Must not have autoimmune diseases or other conditions that could interfere with the study.
  • Must not have active infections or have received a live vaccine recently.
  • Must not have other cancers within the past five years, except for certain non-threatening types.
  • Must not have uncontrolled high blood pressure or significant heart disease.
  • Must not have had recent major surgery or significant injuries.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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