Radiosurgery + Immunotherapy for Breast Cancer Brain Metastases

Recruiting in Palo Alto (17 mi)

Overseen byKamran Ahmed, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This study is to find out if administration of stereotactic radiosurgery (SRS) given after Nivolumab will improve overall response rate/anti-tumor activity in patients with metastatic breast cancer with brain metastases.

Eligibility Criteria

This trial is for adults with breast cancer that has spread to the brain. They must have had prior chemotherapy, no more than 10 brain metastases suitable for stereotactic radiosurgery (SRS), and a good performance status. Pregnant or breastfeeding women, those with leptomeningeal disease, previous whole-brain radiation therapy, certain viral infections, or inadequate organ function are excluded.

Inclusion Criteria

Provides signed and dated informed consent

WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s), plus 5 half-lives of study drug (half-life up to 25 days), plus 30 days (duration of ovulatory cycle) for a total of 5 months after treatment completion.

I can provide a sample of my tumor for testing, or have tried to.

+10 more

Exclusion Criteria

I have a history of testing positive for HIV or AIDS.

Current or prior participation in a study of an investigational agent or investigational device within 2 weeks of first dose of study treatment

I am not allergic to any of the drugs or their components used in this study.

+16 more

Participant Groups

The study tests if giving SRS after Nivolumab improves tumor response in patients with metastatic breast cancer in the brain. It aims to see whether this combination can better manage brain tumors compared to current treatments.

1Treatment groups

Experimental Treatment

Group I: Nivolumab followed by stereotactic radiosurgery (SRS)Experimental Treatment2 Interventions

480 mg Nivolumab will be given intravenously every 4 weeks, followed by SRS the week after the initial dose of Nivolumab.

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: