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Cancer Vaccine

PDS0101 + Pembrolizumab for Head and Neck Cancer (VERSATILE002 Trial)

Phase 2

Waitlist Available

Research Sponsored by PDS Biotechnology Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Checkpoint experienced subjects must have a history of histologically-confirmed diagnosis of HNSCC that is recurrent, metastatic, or persistent with confirmed HPV16 infection, characterization of tumor PDL1 expression using the FDA-approved PD-L1 IHC 22C3 PharmDx Assay, receipt of prior treatment with checkpoint inhibitors as a single agent or in combination, and have received at least 2 doses of the agent or a minimum of 6 weeks on treatment, documented clinical progression or recurrence that has been radiologically confirmed, recurrent and/or metastatic measurable disease based on RECIST 1.1 as assessed by the local PI/radiology, and adequate organ function as defined

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Has a history of interstitial lung disease

Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 and 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying PDS0101 in combination with pembrolizumab to treat patients with HPV16 and PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, digestive issues such as nausea or diarrhea. Each person may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have HPV16+ HNSCC that has not improved after treatment with checkpoint inhibitors.

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I am fully active or can carry out light work.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of lung scarring or fibrosis.

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

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I am currently being treated for an infection.

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I have had or currently have lung inflammation treated with steroids.

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I haven't had any cancer treatment or experimental drugs in the last 30 days.

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I have been treated for an autoimmune disease in the last 2 years.

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I have received colony-stimulating factors in the last 30 days.

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I stopped a cancer immunotherapy due to severe side effects.

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I am a woman able to have children and will not use effective birth control during the study.

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I have received an organ or tissue transplant from another person.

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I have had severe side effects from previous immunotherapy.

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I have cancer that has spread to my brain or spinal cord.

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I have HIV or a history of Hepatitis B or C.

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I experienced side effects from immune therapy that haven't improved.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best Overall Response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) of the combination of pembrolizumab and PDS0101.

Secondary study objectives

Therapeutic procedure

Overall Survival in all patients

Progression-Free Survival (PFS) in all patients

Other study objectives

Duration of response for all patients

Evaluate anti-HPV-16 E6 and E7 immune responses elicited by treatment with pembrolizumab and PDS0101

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab and PDS0101Experimental Treatment1 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.

0 / 17Eligibility criteria met