Immunotherapy + Radiation for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Jonathan D. Schoenfeld, 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

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This research study is studying immunotherapy in combination with radiation therapy as a possible treatment for head \& neck cancer that has worsened or spread to another organ or part of your body. The immunotherapy involved in this study is: MK-3475 (pembrolizumab or KEYTRUDA).

Research Team

Jonathan D. Schoenfeld, MD MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults with confirmed metastatic squamous cell carcinoma of the head and neck, who have not benefited from previous PD-1 therapy, can join. They must be in good health otherwise, with proper organ function and no serious heart issues or infections like hepatitis. Pregnant women and those with certain other cancers or autoimmune diseases cannot participate.

Inclusion Criteria

My cancer is a type that started in my head or neck and has spread, with no cure from surgery or radiation.

I am fully active or can carry out light work.

My cancer progressed or didn't improve after treatment with a PD-1 inhibitor.

Exclusion Criteria

Participants who are receiving any other investigational agents

Pregnant women

Individuals with a history of a different malignancy except under specific circumstances

Treatment Details

Interventions

• Pembrolizumab (PD-1 Inhibitor)
• Radiation Therapy (Radiation)

Trial Overview The trial is testing pembrolizumab (KEYTRUDA), an immunotherapy drug, combined with radiation therapy to treat advanced head & neck cancer. The study aims to see if this combination helps patients whose cancer has spread despite prior treatments.

Participant Groups

Group I: High Dose Radiation + Pembrolizumab Experimental Treatment 2 Interventions

* High dose radiation will be given in 3 fractions * Pembrolizumab administered intravenously on day one of each cycle.

Group II: High Dose + Low Dose Radiation + Pembrolizumab Experimental Treatment 2 Interventions

* High Dose radiation will be given in 3 fractions * Low Dose Radiation will be given in 2 fractions * Pembrolizumab administered intravenously on day one of each cycle.

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

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University