PDS0101 + Pembrolizumab for Head and Neck Cancer

(VERSATILE-003 Trial)

Not currently recruiting at 23 trial locations

Overseen By Sokary Clinical Operations Lead

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: PDS Biotechnology Corp.

Must not be taking: Immunosuppressants, Steroids, Live vaccines, others

Disqualifiers: Immunodeficiency, Autoimmune disease, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a new combination of treatments could surpass a standard treatment for head and neck cancer that is difficult to remove or has spread. It compares the use of PDS0101 (an experimental treatment) with pembrolizumab (an immunotherapy drug) against pembrolizumab alone, focusing on cancers linked to the HPV16 virus and the PD-L1 protein marker. It suits individuals with head and neck cancer associated with HPV16 who have not received major treatment for advanced-stage cancer. Participants should have cancer located in specific areas like the throat or mouth and meet certain eligibility criteria. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have had certain treatments like immunotherapy or systemic anticancer therapy recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study demonstrated promising safety results for the combination of PDS0101 and pembrolizumab. This combination was tested in adults with a specific type of head and neck cancer. Most participants tolerated the treatment well, with no major safety concerns. Some patients experienced mild to moderate side effects, which were manageable.

Pembrolizumab, when used alone, is already approved for similar conditions and has a well-known safety profile, meaning doctors understand its effects on patients.

The combination of PDS0101 and pembrolizumab showed positive results in extending patients' lives, indicating that the treatment is effective and generally well-tolerated.

Overall, the safety data for PDS0101 and pembrolizumab together is encouraging. Ongoing research aims to confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for head and neck cancer?

Researchers are excited about PDS0101 combined with pembrolizumab because it represents a novel approach to treating head and neck cancer. Unlike traditional treatments like surgery, radiation, and chemotherapy, this combination harnesses the power of the immune system. PDS0101 is a unique vaccine therapy that stimulates the immune system to specifically target and attack cancer cells. When paired with pembrolizumab, an immune checkpoint inhibitor, this treatment has the potential to enhance the immune response even further, potentially leading to better outcomes for patients. This innovative strategy offers hope for improved effectiveness and fewer side effects compared to current options.

What evidence suggests that this trial's treatments could be effective for head and neck cancer?

In this trial, participants will be assigned to one of two treatment arms. The interventional arm will receive a combination of PDS0101 and pembrolizumab. Research has shown that using PDS0101 with pembrolizumab holds promise for treating head and neck cancer. Specifically, studies demonstrated that this combination helped patients with HPV16-positive cancer live for a median of 39.3 months, longer than with pembrolizumab alone. PDS0101 is designed to enhance the body's immune response against HPV-related cancers. This combination therapy has shown significant benefits even for patients with lower levels of PD-L1, a protein that can affect the immune system. Overall, these findings suggest that this treatment could significantly extend survival for patients with this type of cancer. ^{2 3 4 6 7}

Who Is on the Research Team?

David Schaaf, MD

Principal Investigator

PDS Biotechnology Corporation

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.6037

Versatile-002: Overall survival of HPV16-positive recurrent/ ... Median overall survival (OS) with pembrolizumab in first-line recurrent/metastatic (R/M) HNSCC is 12.3 months in subjects with CPS ≥1, 10.8 months for CPS ≥1- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06790966

Phase 3 Study of PDS0101 and Pembrolizumab in ... PDS0101 is a T cell activating immunotherapy designed to induce HPV-specific CD8 and CD4 T cells. A Phase 2 study has shown promising signs of safety and ...

3. cancernetwork.com cancernetwork.com/view/pds0101-plus-pembrolizumab-yields-positive-survival-results-in-hnscc

PDS0101 Plus Pembrolizumab Yields Positive Survival ... The median overall survival was 39.3 months with PDS0101 plus pembrolizumab in those with frontline recurrent or metastatic head and neck ...

4. targetedonc.com targetedonc.com/view/pds0101-combo-therapy-delivers-survival-boost-in-hnscc-for-patients-with-low-pd-l1

PDS0101 Combo Therapy Delivers Survival Boost in ... A subanalysis of the VERSATILE-002 study highlights significant survival benefits for HNSCC patients with low PD-L1 expression using PDS0101 ...

5. onclive.com onclive.com/view/pds0101-plus-pembrolizumab-yields-durable-survival-benefit-in-hpv16-hnscc

PDS0101 Plus Pembrolizumab Yields Durable Survival ... Versamune HPV (formerly PDS0101) in combination with pembrolizumab (Keytruda) generated a median overall survival (OS) of 39.3 months (95% ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04260126

NCT04260126 | Study of PDS0101 and Pembrolizumab ... 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 ...

7. pdsbiotech.com pdsbiotech.com/index.php/investors/news-center/press-releases/press-releases1/132-2025-news/995-pds-biotech-unveils-updated-positive-data-from-versatile-002-trial-and-additional-trials-evaluating-versamune-r-hpv-to-treat-head-and-neck-cancers-at-the-2025-american-society-of-clinical-oncology-asco-annual-meeting

PDS Biotechnology Median overall survival data in first-line recurrent/metastatic (1L r/m) HNSCC remains durable at 30.0 months with additional follow-up of ...