Pembrolizumab Concurrent With and Following Carbon-ion Radiotherapy for Locally Advanced Cervical… (NCT06805864) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Pembrolizumab Concurrent With and Following Carbon-ion Radiotherapy for Locally Advanced Cervical Adenocarcinoma
Japan45 participantsStarted 2025-02-01
Plain-language summary
The goal of this clinical trial is to learn if pembrolizumab works for cervical adenocarcinoma treat with concurrent chemo-carbon-ion radiaotherapy (CIRT).
The main questions it aims to answer are:
• Does concurrent chemo-CIRT with pembrolizumab improves 2-year progression-free survival (PFS), compared with concurrent chemoradiotherapy with conventional X-rays?
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed adenocarcinoma or adenosquamous carcinoma of the uterine cervix and Stage â…¡A2, â…¡B, â…¢A, â…¢B, â…¢C1r, IVA according to FIGO classification (2018) will be enrolled in this study.
2\. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
3\. Have measurable disease based on RECIST 1.1.
4\. Archival tumor tissue sample or a newly obtained biopsy of a tumor lesion that was not previously irradiated was provided. Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsy samples are preferred to archived tissues.
5\. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of pembrolizumab.
6\. Have adequate organ function below. Specimens must be collected within 10 days to the start of pembrolizumab administration.
* Absolute neutrophil count (ANC) ≥ 1500/µL, Platelets ≥ 100000/µ, Hemoglobin ≥9.0 g/dL or ≥ 5.6 mmol/L, Creatinine clearance ≥ 50 mL/min, Total bilirubin ≤1.5 ×ULN or direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN, AST and ALT ≤2.5 × ULN, International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless participant is …
What they're measuring
1
Progression-free survival (PFS)
Timeframe: At 2 years after the start of trial treatment