Bevacizumab + Atezolizumab +/- Cobimetinib for Melanoma Brain Metastases

Palo Alto (17 mi)

Hussein A. Tawbi | MD Anderson Cancer ...

Overseen byHussein A. Tawbi

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase II trial studies how well bevacizumab and atezolizumab with or without cobimetinib work in treating patients with untreated melanoma that has spread to the brain (brain metastases). Monoclonal antibodies, such as bevacizumab and atezolizumab, may interfere with the ability of tumor cells to grow and spread. Cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if giving bevacizumab and atezolizumab with or without cobimetinib will work better in treating patients with melanoma brain metastases.

Eligibility Criteria

This trial is for adults with untreated melanoma that has spread to the brain. Participants must be willing to use contraception, have an ECOG performance status of 0-2, and a life expectancy over 12 weeks. They should not have had certain prior treatments or suffer from conditions like autoimmune diseases, severe infections, or significant heart problems.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I've had treatments for melanoma spread outside the brain but not with PD-1/PD-L1 inhibitors.

I can provide tumor samples with a pathology report for PD-L1 testing.

I am 18 years old or older.

My melanoma does not have the BRAFV600 mutation.

I have a brain tumor that can be measured.

Exclusion Criteria

I have active tuberculosis.

I have not had severe infections in the last 4 weeks.

My side effects from cancer treatment are mild, except for hair loss.

I am allergic to bevacizumab, atezolizumab, or cobimetinib.

I have a serious wound, ulcer, or untreated bone fracture that is not healing.

I have not had any other cancers in the last 5 years.

I haven't had any cancer treatment, including chemotherapy or hormonal therapy, in the last 3 weeks.

I have a history of HIV or active hepatitis B/C.

Treatment Details

The study is testing how well the combination of monoclonal antibodies (bevacizumab and atezolizumab) works with or without cobimetinib in treating melanoma brain metastases. It aims to see if adding cobimetinib improves treatment outcomes.

2Treatment groups

Experimental Treatment

Group I: Arm II (atezolizumab, bevacizumab, cobimetinib)Experimental Treatment4 Interventions

Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Cycles with atezolizumab and bevacizumab repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients also receive cobimetinib PO TID on days 1-21. Cycles with cobimetinib repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (atezolizumab, bevacizumab)Experimental Treatment3 Interventions

Participants receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: