This is a multi-center study in patients with un-resectable Recurrent or Metastatic HPV16-positive oropharyngeal Head and Neck Squamous Cell Carcinoma (HNSCC). The trial is designed to investigate VB10.16, an investigational therapeutic DNA vaccine in combination with another medicine, pembrolizumab, which is the standard of care for patients with previously untreated metastatic or resectable recurrent PD-L1 positive HNSCC. The study is divided in 2 parts: * Phase 1: Dose escalation to evaluate safety and determine the recommended phase 2 dose (RP2D) of VB10.16 * Phase 2: Randomized comparison of VB10.16 in combination with pembrolizumab versus pembrolizumab monotherapy The goal of Phase 1 is to evaluate the safety and tolerability of the combined treatment and to decide on the dose of VB10.16 to be used in the second part of the trial. The randomized Phase 2 will consist of 2 parallel arms exploring VB10.16 at the selected RP2D from the escalation phase in combination with pembrolizumab SoC (experimental arm, Arm A), versus pembrolizumab alone (control arm, Arm B).
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
This trial is no longer recruiting — here are similar active trials
Matched by cancer type/biomarker, currently recruiting.
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About the trial
This phase II trial studies if talazoparib works in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and has mutation(s) in deoxyribonucleic acid (DNA) damage response genes who have or have not already been treated with another PARP inhibitor. Talazoparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. All patients who take part on this study must have a gene aberration that changes how their tumors are able to repair DNA. This trial may help scientists learn whether some patients might benefit from taking different PARP inhibitors "one after the other" and learn how talazoparib works in treating patients with advanced cancer who have aberration in DNA repair genes.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dorosły pacjent z potwierdzoną zmianą genetyczną w genach odpowiedzialnych za naprawę DNA, których nowotwór progresywnie się rozwijał mimo poprzedniego leczenia
- •Posiadanie mutacji w genach BRCA1 lub BRCA2
- •Posiadanie mutacji w genach zespołu Fanconiego (FANCA, FANCB, FANCC, FANCD2 i inne)
- •Posiadanie mutacji w wybranych genach naprawy DNA (ATM, ATR, BRIP1, BAP1, CDK12, CHK2, RAD51 i inne)
- •Wiek co najmniej 18 lat
- •Dobry stan ogólny pacjenta (ECOG ≤ 2)
- •Spodziewana długość życia dłuższa niż 3 miesiące
- •Wykluwalne lub mierzalne ognisko nowotworu dostępne do pobrania próbki
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 19, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (4)
UF Health Cancer Institute - Gainesville
Gainesville, United States
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, United States
National Institutes of Health Clinical Center
Bethesda, United States
University of Oklahoma Health Sciences Center
Oklahoma City, United States
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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