Nivolumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Trisha Wise-Draper, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Trisha Wise-Draper

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to test the safety and efficacy of nivolumab after salvage resection in head and neck cancer in patients that have previously received definitive radiation with or without chemotherapy.

Research Team

Trisha Wise-Draper, MD

Principal Investigator

University of Cincinnati

Eligibility Criteria

This trial is for individuals who have had head and neck cancer, were treated with radiation (and possibly chemotherapy), and then underwent surgery to remove the cancer. They should be in good health otherwise, able to undergo scans, provide tissue samples, and have no other treatment options.

Inclusion Criteria

I've had the required scans before surgery, including a PET/CT and CT or MRI of the neck.

My health status and lab results meet the required standards.

I can provide samples from my previous biopsy or surgery.

Exclusion Criteria

I have not had radiotherapy as my main cancer treatment.

I have cancer in my nasal area or upper throat.

My cancer has spread to other parts of my body.

Treatment Details

Interventions

• Nivolumab (Checkpoint Inhibitor)

Trial Overview The study is examining the effectiveness of Nivolumab as an additional treatment after surgical removal of head and neck cancer in patients who've already received radiation therapy. It aims to see if this drug can improve outcomes post-surgery.

Participant Groups

Group I: Nivolumab Experimental Treatment 1 Intervention

Nivolumab starting 4-11 weeks after surgery for 6 doses.

Who Is Running the Clinical Trial?

Trisha Wise-Draper

Lead Sponsor

Trials

6

Recruited

230+

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