PDS0101 + Pembrolizumab for Head and Neck Cancer

(VERSATILE002 Trial)

Recruiting in Palo Alto (17 mi)

+28 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: PDS Biotechnology Corp.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

VERSATILE-002 is a Phase 2, open-label, multicenter study of the efficacy and safety of PDS0101 administered in combination with pembrolizumab in adults with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Research Team

David T Schaaf, MD

Principal Investigator

PDS Biotechnology Corporation

Eligibility Criteria

Adults over 18 with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who've had prior checkpoint inhibitor treatment can join. They need measurable disease, adequate organ function, no recent major surgery or radiation without recovery, not pregnant or breastfeeding, willing to use contraception, and have an ECOG status of 0-1.

Inclusion Criteria

I am not pregnant, can use birth control during the study, and if male, will use a condom.

Participant (or legally acceptable representative if applicable) provides written informed consent for the study

My cancer is HPV16 positive, has PDL1 expression, and I haven't had immunotherapy.

Exclusion Criteria

Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients

I have a history of lung scarring or fibrosis.

I had a stem cell transplant from a donor within the last 5 years.

Treatment Details

Interventions

• PDS0101 (Cancer Vaccine)
• Pembrolizumab (PD-1/PD-L1 Inhibitor)

Trial Overview The VERSATILE-002 Phase 2 trial is testing the effectiveness and safety of PDS0101 in combination with pembrolizumab for treating adults with HPV16+ HNSCC that has come back or spread. It's open-label and multicenter, meaning both researchers and participants know what treatment is being given.

Participant Groups

Group I: Pembrolizumab and PDS0101 Experimental Treatment 1 Intervention

Pembrolizumab will be administered via IV Infusion followed by subcutaneous injections of PDS0101 five times throughout the course of the study. Pembrolizumab monotherapy will be administered every cycle there is not a combination treatment until disease progression or up to Cycle 35.

Who Is Running the Clinical Trial?

PDS Biotechnology Corp.

Lead Sponsor

Trials

3

Recruited

460+

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