Nivolumab +/- Ipilimumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Jonathan Schoenfeld, MD

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 nivolumab, an investigational drug, in combination with ipilimumab, also an investigational drug, as a possible treatment for Squamous Cell Carcinoma of the oral cavity. The following drugs are involved in this study: * Nivolumab (Opdivo™) * Ipilimumab (Yervoy™)

Research Team

Jonathan Schoenfeld, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults with squamous cell carcinoma of the oral cavity, who are fit for surgery and have not received certain cancer treatments or have active infections. Participants must be able to tolerate anesthesia, have no history of severe allergies to trial drugs, and women of childbearing age must use effective contraception.

Inclusion Criteria

I am 18 or older and can medically handle the treatment.

My blood tests show normal organ function and I don't have severe anemia or diabetes.

I am eligible for surgery and can undergo general anesthesia without serious risks.

Exclusion Criteria

You have had a serious allergic reaction to any kind of antibody treatment in the past.

Lack of availability for follow up assessments

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

Treatment Details

Interventions

• Ipilimumab (Checkpoint Inhibitor)
• Nivolumab (Checkpoint Inhibitor)
• Standard of Care Surgery (Surgery)

Trial Overview The study is testing nivolumab alone or combined with ipilimumab against standard surgical care in treating oral cavity squamous cell carcinoma. It aims to see if these drugs can improve outcomes before patients undergo surgery.

Participant Groups

Group I: Nivolumab With Ipilimumab Experimental Treatment 3 Interventions

* Nivolumab to be delivered at a pre-determine dose for two weeks * Ipilimumab to be delivered at a pre-determine dose for one week * Blood Sample Collected * Standard of Care Surgery

Group II: Nivolumab Experimental Treatment 2 Interventions

* Nivolumab to be delivered at a pre-determine dose for two weeks * Blood Sample Collected * Standard of Care Surgery

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

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