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).
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
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.
The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC. Study details include: 1. The study duration will be event-driven, with an estimated duration of approximately 8 years. 2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met. 3. The visit frequency will be every 3 weeks during the treatment period. Note: Participants on osimertinib treatment(osimertinib only arm or who have discontinued Dato-DXd while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression or IP discontinuation. Participants who are receiving osimertinib + Dato-DXd are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.
This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
This is a two-part, Phase I/II, open-label, global, multicenter study assessing the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) versus standard of care in participants with progressive metastatic castrate resistant prostate cancer (mCRPC).
About the trial
This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Hormone Sensitive Prostate Cancer (mHSPC) and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zdiagnozowany rak prostaty z przerzutami w innych częściach ciała
- •Przerzuty w narządach lub co najmniej 4 przerzuty w kościach (zarejestrowane tomografią lub badaniem kości)
- •Bardzo niski poziom testosteronu we krwi (wynik leczenia)
- •Ogólny stan zdrowia pozwalający na udział w badaniu
- •Możliwe wcześniejsze leczenie radurem lub chemioterapią (jeśli skończyło się ponad rok temu)
✗ Disqualifies
- •Wcześniejsze leczenie nowymi lekami hamującymi receptor androgenowy (enzalutamid, darolutamid, apalutamid lub abirateron) przy zaawansowanym rakzie
- •Tylko biochemiczny powrót choroby bez potwierdzenia przerzutów w badaniach obrazowych
- •Brak przerzutów widocznych w tomografii lub badaniu kości
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 21, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (66)
University of California San Diego - Moores Cancer Center
La Jolla, United States
Saint Johns Cancer Institute
Santa Monica, United States
Rocky Mountain Cancer Centers
Denver, United States
Yale Cancer Center
New Haven, United States
Advanced Urology Ins Daytona Beach
Daytona Beach, United States
Emory University School of Medicine-Winship Cancer Institute
Atlanta, United States
Associated Urological Specialists
Chicago Ridge, United States
Mass General Hospital
Boston, United States
Michigan Institute of Urology
West Bloomfield, United States
XCancer Omaha LLC
Omaha, United States
Perlmutter Cancer Centre
New York, United States
Associated Med Professionals of NY
Syracuse, United States
Montefiore Medical Center
The Bronx, United States
MidLantic Urology
Bala-Cynwyd, United States
Fox Chase Cancer Center
Philadelphia, United States
Carolina Urologic Research Center
Myrtle Beach, United States
Tennessee Oncology
Nashville, United States
Urology San Antonio
San Antonio, United States
Inova Schar Cancer Institute
Fairfax, United States
Virginia Oncology Associates
Norfolk, United States
Fred Hutch Cancer Research
Seattle, United States
Novartis Investigative Site
Adelaide, Australia
Novartis Investigative Site
Clayton, Australia
Novartis Investigative Site
Fortaleza, Brazil
Novartis Investigative Site
Porto Alegre, Brazil
Novartis Investigative Site
São Paulo, Brazil
Novartis Investigative Site
Vancouver, Canada
Novartis Investigative Site
Halifax, Canada
Novartis Investigative Site
Montreal, Canada
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Brno, Czechia
Novartis Investigative Site
Olomouc, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Nice, France
Novartis Investigative Site
Marseille, France
Novartis Investigative Site
Quint-Fonsegrives, France
Novartis Investigative Site
Suresnes, France
Novartis Investigative Site
Düsseldorf, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Lübeck, Germany
Novartis Investigative Site
Nürtingen, Germany
Novartis Investigative Site
Asti, Italy
Novartis Investigative Site
Padova, Italy
Novartis Investigative Site
Trento, Italy
Novartis Investigative Site
Orbassano, Italy
Novartis Investigative Site
Verona, Italy
Novartis Investigative Site
Zwolle, Netherlands
Novartis Investigative Site
Dordrecht, Netherlands
Novartis Investigative Site
Hoofddorp, Netherlands
Novartis Investigative Site
Schiedam, Netherlands
Novartis Investigative Site
Kielce, Poland
Novartis Investigative Site
Oświęcim, Poland
Novartis Investigative Site
Skorzewo, Poland
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Santander, Spain
Novartis Investigative Site
Badajoz, Spain
Novartis Investigative Site
Lugo, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Córdoba, Spain
Novartis Investigative Site
Kaohsiung City, Taiwan
Novartis Investigative Site
Tainan, Taiwan
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Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/19/2026.
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