Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC (VERSATILE002)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04260126|
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : February 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Head and Neck Cancer Recurrent Head and Neck Cancer HPV Positive Oropharyngeal Squamous Cell Carcinoma HPV-Related Esophageal Squamous Cell Carcinoma Neoplasms, Head and Neck||Combination Product: Pembrolizumab and PDS0101||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-Label, Multi-Center Study of PDS0101 and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy as a First Line Treatment in Subjects With Recurrent and/or Metastatic HNSCC and High-Risk HPV16 Infection|
|Estimated Study Start Date :||February 5, 2021|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||July 2024|
Experimental: Pembrolizumab and PDS0101
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.
Combination Product: Pembrolizumab and PDS0101
IV infusion of pembrolizumab 200 mg + two 0.5mL sub-cutaneous injections of PDS0101 administered on Cycle 1, 2, 3, 4 and 12. IV infusion of Pembrolizumab 200 mg monotherapy will be administered Cycles 5 - 11 and 13 - 35.
- Objective Response Rate (ORR) of the combination of Pembrolizumab and PDS0101 [ Time Frame: 9 months following initial treatment ]RECIST 1.1
- Progression-Free Survival (PFS) in all patients [ Time Frame: 12 and 24 months ]RECIST 1.1
- Overall Survival in all patients [ Time Frame: 24 months ]Overall survival (OS) is defined as time from date of first dose until death from any cause. Those subjects who are still alive will be censored at their last known date of contact.
- Incidence of Treatment-Emergent Adverse Events using NCI CTCAE, version 50 (v.11.27.17) [Safety and Tolerability] of Pembrolizumab and PDS0101 combination treatment [ Time Frame: 24 months ]AE's will be summarized by severity using NCI CTCAE, version 50 (v.11.27.17) and by relationship to study treatment.
- Duration of response for all patients [ Time Frame: Up to 35 months ]Length of time that the subjects who demonstrated ORR at 9 months, continue to respond to treatment.
- Evaluate anti-HPV-16 E6 and E7 immune responses elicited by treatment with pembrolizumab and PDS0101 [ Time Frame: Baseline (Cycle 1) to Day 253 (Cycle 13) ]Using Granzyme B and interferon-γ (IFN-γ) ELISPOT immunoassays to compare pre-treatment baseline with Days 85 (Cycle 5) and 253 (Cycle 13).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260126
|Contact: Misha Binder||(732) firstname.lastname@example.org|
|Contact: Cara Lalley||(908) email@example.com|
|United States, Kentucky|
|University of Kentucky Chandler Medical Center - Markey Cancer Center||Recruiting|
|Lexington, Kentucky, United States, 40536|
|Contact: Whitney Michels firstname.lastname@example.org|
|Principal Investigator: Alexandra Kejner, MD|
|Norton Cancer Institute||Recruiting|
|Louisville, Kentucky, United States, 40241|
|Contact: Jaspreet Grewal, MD Head&Neck-NCIResearch@nortonhealthcare.org|
|Principal Investigator: Jaspreet Grewal, MD|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Ammar Sukari, MD 800-527-6266|
|Principal Investigator: Ammar Sukari, MD|
|United States, Tennessee|
|University of Tennessee||Recruiting|
|Knoxville, Tennessee, United States, 37920|
|Contact: Brenna Adelman 865-305-5131 email@example.com|
|Principal Investigator: Timothy Panella, MD|
|Study Director:||Lauren Wood, MD||PDS Biotechnology Corporation|