Pembrolizumab + Anti-platelet Therapy for Head and Neck Cancer

Overseen by John Kaczmar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Medical University of South Carolina

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if combining two treatments works better than using one treatment alone for patients with head and neck cancer that has come back or spread. The combination aims to improve the immune system's ability to fight the cancer.

Research Team

John Kaczmar, MD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

Adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that expresses PD-L1 or has progressed after chemotherapy can join. They must have a life expectancy of at least 3 months, measurable disease, good performance status, and adequate organ function. Women who can bear children need a negative pregnancy test and agree to use contraception.

Inclusion Criteria

My kidneys work well enough, with a creatinine clearance over 30 mL/min.

I am 18 years old or older.

My cancer can be measured and has grown in areas previously treated with radiation.

Exclusion Criteria

I do not have any major health issues that could affect my treatment.

I have not received any vaccines within 4 weeks before starting pembrolizumab, except for inactivated ones.

I am on blood thinners but can stop them for 7 days.

Treatment Details

Interventions

• Acetylsalicylic acid (Anti-platelet agent)
• Clopidogrel (Anti-platelet agent)
• Pembrolizumab (PD-1 Inhibitor)

Trial Overview The trial is testing if combining Pembrolizumab (an immunotherapy drug) with anti-platelet drugs like acetylsalicylic acid and Clopidogrel improves immune response in patients compared to just using immunotherapy alone.

Participant Groups

Group I: Group 2 Experimental Treatment 3 Interventions

Group 2 will be treated with Regimen B, followed by Regimen A. Regimen B is pembrolizumab alone for 6 weeks. Regimen A is pembrolizumab, ASA and clopidogrel daily for 6 weeks.

Group II: Group 1 Experimental Treatment 3 Interventions

Group 1 will be treated with Regimen A, followed by Regimen B. Regimen A is pembrolizumab, ASA and clopidogrel daily for 6 weeks. Regimen B is pembrolizumab alone for 6 weeks.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Dr. Erik Summers

Medical University of South Carolina

Chief Medical Officer

MD from University of Alabama at Birmingham

Dr. Patrick J. Cawley

Medical University of South Carolina

Chief Executive Officer

MD, MBA