Radiosurgery + Immunotherapy for Breast Cancer Brain Metastases

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Immunosuppressants, AntiPD-1, AntiPD-L1, others

Disqualifiers: Leptomeningeal disease, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

14 Participants Needed

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.

Research Team

Kamran Ahmed, MD

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 480 mg Nivolumab intravenously every 4 weeks, followed by stereotactic radiosurgery (SRS) the week after the initial dose

8 weeks

1 visit (in-person) every 4 weeks for Nivolumab, 1 visit (in-person) for SRS

Safety Observation

Participants are monitored for dose limiting toxicities, with an 8-week safety observation period

8 weeks

Follow-up

Participants are monitored for intracranial and extracranial progression-free survival and overall survival

Up to 24 months

Treatment Details

Interventions

• Nivolumab
• Stereotactic Radiosurgery

Trial Overview 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.

Participant Groups

Group I: Nivolumab followed by stereotactic radiosurgery (SRS) Experimental Treatment 2 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:

• Advanced or metastatic gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma
• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Hepatocellular carcinoma
• Esophageal squamous cell carcinoma

Approved in European Union as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania