Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT05232851
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2022-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Stimulating Immune Response With Neoadjuvant Human Papilloma Virus (HPV)-16 Specific Vaccination in HPV-Oropharyngeal Squamous Cell Carcinoma (HPV-OPSCC)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I/II trial studies how well PDS0101 alone or in combination with pembrolizumab works to shrink tumor in patients with human papillomavirus-associated oropharynx cancer that has spread to nearby tissue or lymph nodes (locally advanced). PDS0101 is a vaccine made from specific peptides that may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving PDS0101 with or without pembrolizumab may kill more tumor cells in patients with locally advanced human papillomavirus-associated oropharynx cancer before surgery so that it may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine pathologic and human papillomavirus cell-free tumor deoxyribonucleic acid (ctHPVDNA) response to liposomal HPV-16 E6/E7 multipeptide vaccine PDS0101 (PDS0101) or PDS0101 plus pembrolizumab in patients with high risk human papillomavirus-associated oropharynx cancer (HPV-OPSCC).
SECONDARY OBJECTIVES:
I. To determine tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
II. To determine progression-free survival and overall survival.
TERTIARY OBJECTIVES:
I. To determine the safety of PDS0101 delivered alone or with pembrolizumab.
CORRELATIVE RESEARCH OBJECTIVES:
I. Determine the changes in tumor microenvironment (TME) with PDS0101 alone or with pembrolizumab.
II. Determine circulating ctHPVDNA as a biomarker for tumor response. III. Determine HPV16-specific T-cell response utilizing multiplex flow cytometry and other parameters.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive PDS0101 subcutaneously (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 computed tomography (CT) or fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
ARM B: 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.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
I. To determine pathologic and human papillomavirus cell-free tumor deoxyribonucleic acid (ctHPVDNA) response to liposomal HPV-16 E6/E7 multipeptide vaccine PDS0101 (PDS0101) or PDS0101 plus pembrolizumab in patients with high risk human papillomavirus-associated oropharynx cancer (HPV-OPSCC).
SECONDARY OBJECTIVES:
I. To determine tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
II. To determine progression-free survival and overall survival.
TERTIARY OBJECTIVES:
I. To determine the safety of PDS0101 delivered alone or with pembrolizumab.
CORRELATIVE RESEARCH OBJECTIVES:
I. Determine the changes in tumor microenvironment (TME) with PDS0101 alone or with pembrolizumab.
II. Determine circulating ctHPVDNA as a biomarker for tumor response. III. Determine HPV16-specific T-cell response utilizing multiplex flow cytometry and other parameters.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive PDS0101 subcutaneously (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 computed tomography (CT) or fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT and blood sample collection throughout the trial. Patients may undergo a biopsy during screening and on the trial.
ARM B: 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.
After completion of study treatment, patients are followed every 3 months for up to 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: