Pembrolizumab for Head and Neck Cancers

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Alexander Pearson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Chicago

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

A placebo-controlled, randomized study using adjuvant pembrolizumab treatment for one year in order to potentially improve progression free survival in a squamous cell carcinoma of the head and neck cohort at high-risk for recurrence.

Research Team

Alexander Pearson, MD

Principal Investigator

University of Chicago

Eligibility Criteria

Adults with head and neck squamous cell carcinoma who've finished curative treatment within the last 20 weeks, at high risk of cancer coming back. They must have good performance status, agree to use contraception, and not be pregnant or breastfeeding. Excluded are those with active infections like TB or hepatitis, recent other treatments or trials, certain autoimmune diseases, another progressing cancer, CNS metastases, or a history of severe reactions to pembrolizumab.

Inclusion Criteria

Be willing and able to provide written informed consent/assent for the trial

I can provide at least 10 slides of my tumor for testing.

I agree to use birth control during and for 4 months after the study.

Exclusion Criteria

I have cancer that has spread to my brain or spinal cord.

Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of trial treatment

I have a history of HIV or active Hepatitis B/C.

Treatment Details

Interventions

• Pembrolizumab (Checkpoint Inhibitor)
• Placebo (Other)

Trial Overview The PATHWay Study is testing if pembrolizumab can prevent cancer from returning in patients with high-risk head and neck cancers after they've completed their main treatment. Participants will either receive pembrolizumab or a placebo for one year in this double-blind study where neither doctors nor patients know who's getting the real drug.

Participant Groups

Group I: Placebo Experimental Treatment 1 Intervention

iv, every 3 weeks, x 1 year

Group II: Pembrolizumab Experimental Treatment 1 Intervention

200mg, every three weeks, iv, x 1 year

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago