Nivolumab + Ipilimumab for Breast Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Sara Tolaney, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This research study is studying a drug combination of nivolumab and ipilimumab as a possible treatment for hypermutated HER2 negative breast cancer. The drugs involved in this study are: * Nivolumab (Opdivo ®) * Ipilimumab (Yervoy ®)

Eligibility Criteria

This trial is for adults with metastatic HER2-negative breast cancer that's hypermutated (TMB ≥9 mutations/megabase). They can have had up to three prior chemo treatments and must be off chemo for at least 14 days. Participants need functioning major organs, no severe illnesses, not pregnant or breastfeeding, and agree to use effective contraception.

Inclusion Criteria

I have recovered from previous cancer treatment side effects, except for hair loss and numbness.

I am mostly able to care for myself and carry out daily activities.

My breast cancer is HER2-negative and may be hormone receptor positive or negative.

Exclusion Criteria

I have not received a live vaccine in the last 28 days.

I have not taken any other cancer treatments in the last 14 days.

I do not have any other cancer needing treatment at the same time.

Participant Groups

The study tests a combination of two drugs: Nivolumab (Opdivo) and Ipilimumab (Yervoy), as potential treatment for this type of breast cancer. It includes patients who've tried other treatments without success and measures the effectiveness of these drugs in controlling the disease.

Group I: Nivolumab+Ipilimumab Experimental Treatment 2 Interventions

* Ipilimumab is administered intravenously every 6 weeks * Nivolumab is administered intravenously every 2 weeks

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

🇺🇸 Approved in United States as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

🇪🇺 Approved in European Union as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dana-Farber Cancer Institute Boston, MA

University of Pittsburgh Medical Center Pittsburgh, PA

University of Texas Southwestern Medical Center Dallas, TX

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute Lead Sponsor

Bristol-Myers Squibb Industry Sponsor

References