Study Comparing Induction Nivolumab-Ipilimumab Followed by Chemoradiation Versus Chemoradiation Alone for Advanced Cervical Cancer

What this Trial Is About

Researchers are evaluating treatments for women with locally advanced cervical cancer, specifically adenocarcinoma or squamous cell carcinoma at certain stages FIGO Stage IB2-IB3 node positive or Stage IIB-IVA. The study compares standard cisplatin-based chemoradiation with a combination of immunotherapy drugs nivolumab and ipilimumab followed by chemoradiation. This Phase II trial aims to assess 3-year progression-free survival among participants. Participants are randomly assigned to one of two groups. One group receives standard radiation therapy targeting 45 Gy in 25 fractions with concurrent weekly cisplatin or carboplatin chemotherapy. The other group receives 4 cycles of induction immunotherapy with nivolumab and ipilimumab every 3 weeks, followed by the same radiation and chemotherapy regimen combined with nivolumab every 2 weeks. The study includes detailed treatment schedules and dosing for all therapies. During the study, participants will undergo regular evaluations including imaging to assess lesions, health-related quality of life assessments, and monitoring for treatment-related toxicities. Researchers will measure outcomes such as 3-year progression-free survival, overall survival, response rates, and quality of life changes. The total follow-up period includes assessments up to three years after treatment to monitor effectiveness and safety.

Nivolumab-ipilimumab and Chemoradiation for Cervical Cancer