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).
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02
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 study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobiety w wieku od 18 do 75 lat.
- •Zdiagnozowany rak piersi z przerzutami, który jest dodatni pod względem hormonów (estrogenu i/lub progesteronu) i ujemny pod względem HER2.
- •Rak jest miejscowo zaawansowany (nie można go całkowicie usunąć miejscowo) lub powrócił w formie przerzutów.
- •Choroba jest mierzalna w badaniach obrazowych lub obecne są zmiany w kościach, nawet jeśli nie są mierzalne.
- •Organizm dobrze reaguje na leczenie (prawidłowe wyniki badań krwi dotyczące białych krwinek, płytek krwi i hemoglobiny).
- •Pacjentka wcześniej nie otrzymywała chemioterapii ani leczenia celowanego z powodu przerzutów.
- •Dobre ogólne samopoczucie (wskazane przez punktację ECOG ≤ 2) i przewidywana długość życia co najmniej 3 miesiące.
- •Pacjentka świadomie zgadza się na udział w badaniu i przestrzega jego zasad.
✗ Disqualifies
- •Leczenie chemioterapią, radioterapią, immunoterapią lub zabiegi chirurgiczne z powodu choroby z przerzutami w ostatnim czasie (z wyjątkiem drobnych zabiegów ambulatoryjnych).
- •Aktywne lub objawowe przerzuty do mózgu, które wymagają leczenia.
- •Poważne problemy z sercem (np. niewydolność serca, zawał serca w ciągu ostatnich 6 miesięcy).
- •Ciąża lub karmienie piersią.
- •Inne nowotwory zdiagnozowane w ciągu ostatnich pięciu lat (z wyjątkiem wyleczonego raka skóry podstawno-komórkowego).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- February 8, 2024
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Fudan University Shanghai cancer center
Shanghai, China
Trial contact
Zhi-Ming Shao
Zhong-Hua Wang
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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