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Cancer Vaccine

PDS0101 Vaccine + Pembrolizumab for Oropharyngeal Cancer

Phase 1 & 2
Recruiting
Led By David M. Routman, M.D.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of pathologic and human papillomavirus cell-free tumor deoxyribonucleic acid (ctHPVDNA) response
Secondary outcome measures
Incidence of adverse events (AEs)
Overall survival (OS)
Progression-free survival (PFS)
+1 more

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
Computed Tomography
2017
Completed Phase 2
~2790
Biopsy
2014
Completed Phase 4
~840
Biospecimen Collection
2004
Completed Phase 2
~1920
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,487 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,371 Total Patients Enrolled
David M. Routman, M.D.Principal InvestigatorMayo Clinic in Rochester

Media Library

Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05232851 — Phase 1 & 2
Oropharyngeal Cancer Research Study Groups: Arm B (PDS0101, pembrolizumab), Arm A (PDS0101)
Oropharyngeal Cancer Clinical Trial 2023: Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 Highlights & Side Effects. Trial Name: NCT05232851 — Phase 1 & 2
Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05232851 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment capacity for this medical experiment?

"Affirmative. Clinicaltrials.gov's records show that the trial was first made public on March 7th 2022 and has been actively searching for participants since then; it is currently seeking 24 volunteers from 1 medical centre."

Answered by AI

Is enrollment still open for this research project?

"According to the information provided by clinicaltrials.gov, this medical trial is presently enrolling patients with its initial posting on March 7th 2022 and a recent update taking place on March 11th 2022."

Answered by AI
~3 spots leftby Jul 2024