PDS0101 + Pembrolizumab for Head and Neck Cancer

(VERSATILE-003 Trial)

Recruiting at 5 trial locations

Overseen By Sokary Clinical Operations Lead

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: PDS Biotechnology Corp.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 27 months

351 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a global, multi-center, Phase 3 study that is randomized 2:1, controlled, and open label to evaluate PDS0101 (Versamune + HPVMix) in combination with pembrolizumab vs. pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16-positive HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1.

Research Team

David Schaaf, MD

Principal Investigator

PDS Biotechnology Corporation

Eligibility Criteria

This trial is for adults with HPV16-positive head and neck squamous cell carcinoma that's come back or spread and can't be removed by surgery. Participants must have a certain level of immune response (PD-L1 expression), good kidney, liver, and blood health, no recent cancer treatments in the metastatic setting, and measurable disease according to specific criteria.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

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

My organs are functioning well.

Exclusion Criteria

I am currently being treated for an infection.

If the urine pregnancy test is positive. If the urine test cannot be confirmed as negative, a serum pregnancy test will be required

My cancer originates in the nasopharynx.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PDS0101 in combination with pembrolizumab or pembrolizumab monotherapy

27 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

21 months

Long-term follow-up

Participants are monitored for overall survival and quality of life measures

48 months

Treatment Details

Interventions

• PDS0101
• Pembrolizumab

Trial Overview The study compares two treatments: one group receives PDS0101 combined with pembrolizumab; another gets only pembrolizumab. It's a global Phase 3 trial where patients are randomly assigned to either treatment in a ratio of 2:1.

Participant Groups

Group I: Interventional Arm Experimental Treatment 1 Intervention

PDS0101 + Pembrolizumab

Group II: Control Arm Active Control 1 Intervention

Pembrolizumab

Who Is Running the Clinical Trial?

PDS Biotechnology Corp.

Lead Sponsor

Trials

3

Recruited

460+