NCT06805864

Pembrolizumab Concurrent With and Following Carbon-ion Radiotherapy for Locally Advanced Cervical Adenocarcinoma

Pembrolizumab Concurrent With and Following Carbon-ion Radiotherapy for Locally Advanced Cervical Adenocarcinoma (BROTHER STUDY)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Gunma University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab (KEYTRUDA®)	Pembrolizumab is administered at 200 mg every 3 weeks for the first 2 cycles during Chemo-CIRT, after completion of radiotherapy, the dose is increased to 400 mg and given every 6 weeks for a total of 17 cycles over 2 years.

Timeline

• Start date: 2025-02-01
• Primary completion: 2029-12-31
• Completion: 2030-12-31
• First posted: 2025-02-03
• Last updated: 2025-02-03

Locations

1 site across 1 country: Japan