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Recurrent Head and Neck CancerPhase 3VERSATILE-003NCT06790966

Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

A Phase 3 study testing Combination Treatment of PDS0101 and Pembrolizumab and Pembrolizumab Monotherapy in people with Recurrent Head and Neck Cancer and Metastatic Head and Neck Cancer, run by PDS Biotechnology Corp. at 28 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a global, multi-center, Phase 3 study that is randomized 1:1, 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Combination Treatment of PDS0101 and Pembrolizumab and Pembrolizumab Monotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
28 sitesUnited States
Study dates
30 May 2025to 25 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject (or legally acceptable representative, if applicable) provides written informed consent for the study.
  • Subject is ≥18 years of age on the day of signing the informed consent.
  • Have a history of histologically- or cytologically-confirmed diagnosis of recurrent and/or metastatic squamous cell cancer of the head and neck (HNSCC) with:
  • Eligible primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.
  • HPV16 tumor positivity (central testing).
  • Tumor PD-L1 expression defined as a CPS ≥ 1 using the FDA- approved pembrolizumab (KEYTRUDA®) assay (local testing).
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  • No prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomization, if given as part of multimodal treatment for locally advanced disease, is allowed.
  • Have measurable disease based on RECIST 1.1 as determined by the site and confirmed by BICR. As a guidance to the site investigators, tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Subject has adequate organ function defined by the following parameters (all specimens must be collected within 15 days prior to randomization):
  • Hematological: Absolute neutrophil count (ANC) ≥1500/μL, Platelets ≥100,000/μL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L;
  • Renal: Estimated glomerular filtration rate ≥30 mL/min using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • Hepatic: Total bilirubin ≤1.5 × ULN or direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5 × ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5 ULN (if approved by Medical Monitor, ≤5 × ULN for subjects with liver metastases; AST and ALT >5 to 20 x ULN may be included if asymptomatic).
  • Coagulation: INR, prothrombin time (PT) ≤1.5 × ULN; if subject is receiving anticoagulant therapy, INR or PT- should be within therapeutic range of anticoagulant.
  • For female subjects defined as women of childbearing potential (WOCBP), a negative pregnancy test must be obtained during screening. If a urine test cannot be confirmed as negative, a serum pregnancy test will be required. Women who are surgically sterile or at least 2 years postmenopausal do not require pregnancy testing.
  • Male subjects of childbearing potential must agree to use a condom as an effective method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Who cannot join

  • Primary tumor location of nasopharynx (any histology).
  • If the pregnancy test is positive. If a urine test cannot be confirmed as negative, a serum pregnancy test will be required.
  • Has received prior therapy with HPV-specific immunotherapy including therapeutic cancer vaccines and cellular immunotherapy. Note: subjects who have received prophylactic HPV vaccines are eligible for enrollment.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD- L2 agent or with an agent directed to another stimulatory or co- inhibitory T cell receptor including but not limited to CTLA-4, OX40, CD137.
  • Has had major surgery, including surgical resection of tumor, within 30 days prior to randomization, and has not fully recovered as assessed by the investigator.
  • Has received radiotherapy prior to randomization outside of the following minimum washout periods, and has not fully recovered as assessed by the investigator:
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  • Fractionated radiotherapy, 2 weeks
  • Stereotactic radiosurgery, 1 week
  • Palliative radiation therapy, 1 week
  • Has received a live vaccine within 30 days prior to randomization.
  • Examples of live vaccines include, but are not limited to, the following:
  • measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist ® ) or live attenuated vaccines are not allowed within 30 days prior to randomization.
  • Has received immunomodulatory or immunosuppressive agents (e.g., interferons (IFNs), tumor necrosis factor, interleukins, immunoglobulins or other biological response modifiers (granulocyte colony-stimulating factor [GCSF] or granulocyte macrophage stimulating factor [GMCSF]) within 30 days prior to randomization.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 30 days prior to randomization. Note: Subjects who entered the follow-up phase of an investigational study may participate as long as it is permitted in that study consent and has been 30 days after the last dose of the previous investigational agent.
  • Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. Note: Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft- versus-host disease [GVHD].
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (I a dose exceeding 10 mg daily of prednisone equivalent). Note: Current or recent use of intranasal, intra-articular, and topical steroids are allowed for symptom management are clinically indicated.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ, superficial [non- infiltrated] bladder tumors) or other malignant tumors that have undergone potentially curative therapy are eligible for enrollment.
  • Has known carcinomatous meningitis and/or active central nervous system (CNS) metastases as defined by new brain metastases or progressive brain metastases that have not been subjected to CNS-directed therapy since documented progression. Note: Subjects with previously treated brain metastases are eligible if all the following criteria are met:
  • radiologically stable, i.e., without evidence of progression for at least 30 days by repeat imaging (note that repeat imaging should be performed during study screening),
  • neurologically stable, and
  • without requirement of steroid treatment for at least 14 days prior to randomization.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment and is allowed.
  • Has a history of interstitial lung disease or has current pneumonitis. Note: Subjects with a history of radiation pneumonitis who are fully recovered are eligible.
  • Has an active infection requiring systemic therapy (e.g., IV or oral anti-infective).
  • Has known human immunodeficiency virus (HIV) and CD4 count < 350 cells/μL and/or a history of an AIDS-defining opportunistic infection within the past 12 months. Note: Subjects who are on stable antiretroviral therapy for at least 30 days and have an HIV viral load less than 400 copies/mL and who do not meet the above exclusion criterion may be enrolled.
  • Has a history of hepatitis B (HBV) infection or known to be positive for HBV antigen (HbsAg)/HBV virus DNA.
  • Has active hepatitis C defined by a known positive C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay. Note: Subjects with a history of HCV infection who have completed curative antiviral treatment and have HCV viral load below the limit of quantification may be enrolled.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
  • Is breastfeeding within the projected duration of the study, starting with the screening visit through 120 days after the last dose of any study treatment.
  • Has had an allogenic tissue/solid organ transplant.
  • Female subjects defined as WOCBP unwilling or unable to use highly effective contraception method(s) for the duration of the study:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation.
  • Progestogen-only hormonal contraception
  • Intrauterine device
  • Intrauterine hormone-releasing system
  • Bilateral tubal occlusion
  • Vasectomized partner is a highly effective birth control method provided that the partner is the sole sexual partner of the women of childbearing potential (WOCBP) trial participant and that the vasectomized partner has received medical assessment of surgical success.
  • History of allergic or hypersensitivity reactions (≥Grade 3) to pembrolizumab, PDS0101, or their excipients.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

United States28 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University - Winship Cancer Institute (WCI)

    Atlanta, Georgia, 30322

  • Texas Oncology

    Austin, Texas, 78705

  • University of Maryland

    Baltimore, Maryland, 21201

  • University of North Carolina

    Chapel Hill, North Carolina, 27599-7025

  • Medical University of South Carolina

    Charleston, South Carolina, 29407

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • The Ohio State University- James Cancer Hospital

    Columbus, Ohio, 43210

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Marin Cancer Care

    Greenbrae, California, 94904

  • Penn State Health

    Hershey, Pennsylvania, 17033

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • University of Louisville

    Louisville, Kentucky, 40202

  • West Virginia University Cancer Center

    Morgantown, West Virginia, 26506

  • Yale University

    New Haven, Connecticut, 06510

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Florida Cancer Affiliates - Ocala Oncology

    Ocala, Florida, 34474

  • University of California, Orange

    Orange, California, 92686

  • SCRI - Florida Cancer Specialists

    Orlando, Florida, 32827

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19103

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • UT Health San Antonio

    San Antonio, Texas, 78229

  • Texas Oncology-Northeast Texas

    Tyler, Texas, 75702

  • University of Kansas

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: A Phase 3 Open-Label, Randomized Study of PDS0101 and Pembrolizumab vs Pembrolizumab Alone in First-Line Treatment of Unresectable Recurrent and/or Metastatic HPV16+ Head and Neck Squamous Cell Carcinoma

This is a global, multi-center, Phase 3 study that is randomized 1:1, 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.

Read the detailed description

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 efficacy when PDS0101 is combined with pembrolizumab in patients with HPV16-positive R/M HNSCC with CPS ≥1, which is the population for this study.

The dual primary objectives of this study are to compare the effect of the combination of PDS0101 plus pembrolizumab vs. pembrolizumab monotherapy on progression-free survival (PFS) and overall survival (OS). Secondary objectives for this study include comparison of effects on objective response rate (ORR), disease control rate (DCR), and duration of response (DOR).

Being tested
Combination Treatment of PDS0101 and Pembrolizumab, Pembrolizumab Monotherapy
Keywords
Head and neck cancer, Head and neck neoplasms, Neoplasms, squamous cell, Squamous cell carcinoma of the head and neck, Head and neck squamous cell carcinoma, Recurrent Head and Neck cancer, Metastatic Head and Neck Cancer, Immuno-oncology therapy, Human papillomavirus-16, Cancer Vaccines, HNSCC, Oropharyngeal squamous cell carcinoma, HPV, Programmed cell death ligand 1, PD-L1, Immune checkpoint inhibitor, Immune checkpoint inhibitors, Immunotherapy, Squamous cell cancer, Pembrolizumab
Medical subject headings
Head and Neck Neoplasms, Neoplasms, Squamous Cell, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combination Treatment of PDS0101 and PembrolizumabCombination product

    Also called Versamune HPV, KEYTRUDA

    • Pembrolizumab (IV) every 3 weeks for up to 35 Cycles
    • PDS0101 (SC) during Cycles 1, 2, 3, 4, and 12

  • Pembrolizumab MonotherapyDrug

    Also called KEYTRUDA

    Pembrolizumab (IV) every 3 weeks for up to 35 cycles.

Study groups in NCT06790966
Study groupRoleWhat they receive
Interventional ArmExperimentalPDS0101 + Pembrolizumab
Receives: Combination Product: Combination Treatment of PDS0101 and Pembrolizumab
Control ArmActive comparatorPembrolizumab
Receives: Drug: Pembrolizumab Monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS is defined as the time from randomization until death from any cause.

    Measured: Up to 54 months

  2. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. PFS will be based on RECIST 1.1 as assessed by BICR.

    Measured: Up to 18 months

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of subjects with an objective response: a complete response (CR) or partial response (PR) using RECIST 1.1 criteria as assessed by BICR.

    Measured: Up to 27 months

  2. Disease Control Rate (DCR)

    DCR is defined as the percentage of subjects with an objective response of CR, PR, or stable disease (SD, at least 6 weeks after first dose) using RECIST 1.1 criteria as assessed by BICR.

    Measured: Up to 27 months

  3. Duration of Response (DOR)

    DOR is defined as the time from initial response to disease progression or death as determined by using RECIST 1.1 criteria as assessed by BICR.

    Measured: Up to 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2025
  2. Study start30 May 2025
  3. Primary completion25 Aug 2026
  4. Study completion25 Aug 2026

Why it stopped: The study is being discontinued solely based on financial constraints and is not related to the safety of study participants, the investigational product, PDS0101, nor the conduct of the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a Phase 3 open-label, active-control, 1:1 randomized study with parallel assignment of PDS0101 plus pembrolizumab (referred to as 'the investigational arm') vs pembrolizumab alone (referred to as 'the control arm')
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06790966
Sponsor's protocol ID
PDS0101-HNC-301
Acronym
VERSATILE-003
Status last verified
Aug 2026
First submitted
14 Jan 2025
Last updated
2 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Combination Treatment of PDS0101 and Pembrolizumab and Pembrolizumab Monotherapy in people with Recurrent Head and Neck Cancer and Metastatic Head and Neck Cancer, run by PDS Biotechnology Corp. at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study is being discontinued solely based on financial constraints and is not related to the safety of study participants, the investigational product, PDS0101, nor the conduct of the study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to 54 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06790966.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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