Reirradiation + Pembrolizumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Dan Zandberg, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dan Zandberg

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

Eligible participants with locoregional inoperable recurrence or second primary squamous cell carcinoma of the head and neck will be treated with reirradiation combined with anti-PD-1 mAb MK-3475 (generic name: pembrolizumab, trade name Keytruda®).

Research Team

Dan Zandberg, MD

Principal Investigator

UPMC Hillman Cancer Center

Eligibility Criteria

This trial is for adults with a specific type of head and neck cancer that has come back or developed anew and can't be removed by surgery. Participants must have had only one prior radiation treatment, it should be at least 6 months since they finished that treatment, and their cancer needs to be measurable. They should not have used certain immune-targeting drugs before, nor should they have serious infections or other cancers in the last 5 years.

Inclusion Criteria

More than half of my tumor was treated with high-dose radiation without harming my spinal cord.

I have had only one radiation treatment aimed at curing my disease.

My cancer has returned or I have a new cancer in the head or neck area that cannot be surgically removed or I choose not to have surgery.

Exclusion Criteria

I have previously been treated with specific immune therapy drugs.

I have not received a live vaccine in the last 30 days.

I haven't had cancer treatments like chemotherapy in the last 4 weeks and have recovered from any side effects.

Treatment Details

Interventions

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

Trial Overview The study tests reirradiation combined with pembrolizumab (Keytruda®), an immunotherapy drug, on patients whose head and neck cancer has returned or cannot be surgically removed. The goal is to see if this combination helps control the disease better than previous treatments.

Participant Groups

Group I: Reirradiation + MK-3475 Experimental Treatment 2 Interventions

Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation.

Who Is Running the Clinical Trial?

Dan Zandberg

Lead Sponsor

Trials

7

Recruited

330+

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