PDS0101 + Pembrolizumab for Head and Neck Cancer
(VERSATILE-003 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: PDS Biotechnology Corp.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

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.

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.

+8 more

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.

+22 more

Trial 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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional ArmExperimental Treatment1 Intervention

PDS0101 + Pembrolizumab

Group II: Control ArmActive Control1 Intervention

Pembrolizumab