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Cancer Vaccine

PDS0101 Vaccine + Pembrolizumab for Oropharyngeal Cancer

Phase 1 & 2

Recruiting

Led By David M Routman

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Locally advanced HPV-OPSCC with high-risk HPV-specific testing and meeting specific criteria for disease characteristics

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

Must not have

Recent cerebrovascular accident, unstable angina, cardiac procedures, pulmonary embolism, arterial thrombosis, or receipt of immunotherapy/immunosuppressive agents

Other active malignancy within 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is studying PDS0101, a vaccine made from specific peptides, either alone or in combination with pembrolizumab, to see how well it works in treating patients with human papillomavirus-associated oropharynx cancer that has spread to nearby tissue or lymph nodes.

Who is the study for?

Adults over 18 with locally advanced HPV-associated oropharynx cancer, who have not received certain treatments recently and do not have active autoimmune diseases, other cancers within the last 2 years (with some exceptions), or uncontrolled illnesses. Participants must be able to undergo surgery and agree to use contraception if applicable.

What is being tested?

The trial is testing a vaccine called PDS0101 alone or combined with pembrolizumab, an immunotherapy drug. It aims to see if these treatments can shrink tumors before surgery in patients with HPV-related throat cancer. The study will assess how well the body's immune system responds to destroy tumor cells.

What are the potential side effects?

Possible side effects include typical reactions related to vaccines such as soreness at injection site, fever, fatigue; for pembrolizumab: immune-related issues like inflammation of organs, infusion reactions, skin rash, hormone gland problems (like thyroid), and potential infection risks.

Eligibility Criteria

Inclusion Criteria

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

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My throat cancer is advanced, caused by HPV, and meets specific disease criteria.

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

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My kidney function is within the required range.

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I am eligible for surgery or combined chemotherapy and radiation with the aim of curing my condition.

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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 haven't had a stroke, heart issues, blood clots, or taken immune system drugs recently.

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I have not had any other cancer within the last 2 years.

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I am currently using or have used immunosuppressive medication.

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I have had a bone marrow or organ transplant.

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I have had chemotherapy, radiotherapy, or immunotherapy for head or neck cancer.

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I am currently being treated for an autoimmune disease.

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I have not recently had any live vaccines or cancer treatments.

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I do not have any uncontrolled illnesses or infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of pathologic and human papillomavirus cell-free tumor deoxyribonucleic acid (ctHPVDNA) response

Secondary study objectives

Incidence of adverse events (AEs)

Overall survival (OS)

Progression-free survival (PFS)

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (PDS0101, pembrolizumab)Experimental Treatment6 Interventions

Patients receive PDS0101 SC on day 1 and pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.

Group II: Arm A (PDS0101)Experimental Treatment5 Interventions

Patients receive PDS0101 SC on day 1 of each cycle. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or FDG-PET/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Computed Tomography

2017

Completed Phase 2

~2790

Biospecimen Collection

2004