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).
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
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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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
The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Rak piersi z niskim poziomem białka HER2 (oznaczonym jako IHC 2+ lub IHC 1+).
- •Rak piersi, który reaguje na hormony, a dotychczasowe leczenie hormonalne przestało pomagać.
- •Pacjentka otrzymała maksymalnie jedną linię chemioterapii z powodu zaawansowanego raka.
- •Stwierdzono postęp choroby widoczny w badaniach obrazowych.
- •Pacjentka musi mieć co najmniej jedną zmianę chorobową, którą można zmierzyć zgodnie z zasadami badania.
- •Odpowiednia praca serca, szpiku kostnego, nerek, wątroby i krzepliwość krwi.
- •Kobiety w wieku rozrodczym muszą stosować skuteczną antykoncepcję i nie karmić piersią do 7 miesięcy po ostatnim badaniu.
✗ Disqualifies
- •Aktywne przerzuty do mózgu.
- •Znana infekcja wirusem HIV lub aktywne choroby autoimmunologiczne.
- •Przebyte choroby płuc wymagające leczenia sterydami w przeszłości.
- •Choroby serca o umiarkowanym lub ciężkim przebiegu.
- •Aktywne zakażenie wirusem zapalenia wątroby typu B (WZW B) lub C (WZW C).
- •Inne choroby nowotworowe w ciągu ostatnich 5 lat, chyba że ryzyko ich nawrotu lub zgonu jest bardzo niskie.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- August 6, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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