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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 months
Awards & highlights
VERSATILE002 Trial 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.Check my eligibility
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.See study design
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.
VERSATILE002 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have HPV16+ HNSCC that has not improved after treatment with checkpoint inhibitors.
Select...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
VERSATILE002 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best Overall Response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) of the combination of pembrolizumab and PDS0101.
Secondary outcome measures
Therapeutic procedure
Overall Survival in all patients
Progression-Free Survival (PFS) in all patients
Other outcome measures
Duration of response for all patients
Evaluate anti-HPV-16 E6 and E7 immune responses elicited by treatment with pembrolizumab and PDS0101
VERSATILE002 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.
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Who is running the clinical trial?
PDS Biotechnology Corp.Lead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,476 Total Patients Enrolled
31 Trials studying Head and Neck Neoplasms
7,717 Patients Enrolled for Head and Neck Neoplasms
David T Schaaf, MDStudy DirectorPDS Biotechnology Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of lung scarring or fibrosis.I had a stem cell transplant from a donor within the last 5 years.I am currently being treated for an infection.I haven't taken any immune system affecting drugs in the last 6 weeks.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I have had or currently have lung inflammation treated with steroids.I haven't had any cancer treatment or experimental drugs in the last 30 days.I have been treated for an autoimmune disease in the last 2 years.I have another cancer that is growing or was treated in the last 3 years.I have received colony-stimulating factors in the last 30 days.I stopped a cancer immunotherapy due to severe side effects.I am not pregnant, can use birth control during the study, and if male, will use a condom.I am a woman able to have children and will not use effective birth control during the study.I have received an organ or tissue transplant from another person.I have had severe side effects from previous immunotherapy.My cancer is HPV16 positive, has PDL1 expression, and I haven't had immunotherapy.I have cancer that has spread to my brain or spinal cord.I have HPV16+ HNSCC that has not improved after treatment with checkpoint inhibitors.I have HIV or a history of Hepatitis B or C.I am fully active or can carry out light work.I am 18 years old or older.I have not received a live vaccine in the last 30 days.I experienced side effects from immune therapy that haven't improved.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab and PDS0101
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have the FDA granted authorization for Pembrolizumab and PDS0101?
"Both Pembrolizumab and PDS0101 have received a safety rating of 2, as there is some evidence of safe usage but not any that definitively proves efficacy."
Answered by AI
What is the uppermost limit of participants engaged in this research?
"This study necessitates 95 individuals to meet the predetermined criteria for inclusion. Those who are interested can join at Tranquil Clinical Research in Webster, Texas or The University of Virginia in Charlottesville, Virginia."
Answered by AI
Are there any vacancies for participants in this experiment?
"According to the latest data from clinicaltrials.gov, this experiment is presently seeking participants. The initial posting was made on March 29th 2021 and has been modified as recently as November 22nd 2022."
Answered by AI
What are Pembrolizumab and PDS0101 primarily indicated for?
"Pembrolizumab and PDS0101 can both be utilized to treat malignancies, inoperable melanomas, and microsatellite instability high."
Answered by AI
In what geographic areas is this clinical trial taking place?
"24 different trial sites are accepting participants, with locations ranging from Webster to Baltimore. It is beneficial to pick the nearest medical centre in order to reduce transportation exertion if you join the study."
Answered by AI
Could you elucidate on the previous studies that have tested Pembrolizumab and PDS0101?
"Currently, there exist 961 live trials for Pembrolizumab and PDS0101. Of these initiatives, 122 are in the advanced Phase 3 stage of development. Over 35 thousand different sites across Houston, Texas have been established to conduct research on this potential therapeutic protocol."
Answered by AI
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