Study on Pembrolizumab and Chemotherapy Before and After Radiation for High-Risk Cervical Cancer

Program Overview

This study is testing if adding chemotherapy and the immunotherapy drug pembrolizumab before the usual treatment of radiation and chemotherapy can better control cervical cancer that has spread locally. The trial aims to see if this approach improves survival without the cancer getting worse, compared to the standard treatment. Pembrolizumab helps the immune system attack cancer cells, while chemotherapy and radiation work to kill or slow the growth of cancer cells.

Description

The main goal of this study is to find out if starting treatment with pembrolizumab and chemotherapy before radiation and more pembrolizumab can help patients live longer without their cancer getting worse, compared to the standard treatment.

Secondary goals include:

• Checking if this approach helps patients live longer overall.
• Understanding the side effects of starting with pembrolizumab and chemotherapy.
• Looking at how this treatment affects the timing and completion of radiation therapy.
• Studying certain biological markers to see if they can predict how well the treatment works.

Participants are divided into two groups:

Group 1:

• Receive chemotherapy with cisplatin and pembrolizumab, along with radiation therapy for 5 weeks.
• Continue with pembrolizumab every 6 weeks for up to 15 cycles.
• Undergo regular scans and blood tests.

Group 2:

• Start with chemotherapy using carboplatin, paclitaxel, and pembrolizumab for 6 weeks.
• Follow with the same treatment as Group 1, including radiation and pembrolizumab.
• Continue with pembrolizumab every 6 weeks for up to 14 cycles.
• Undergo regular scans and blood tests.

After treatment, participants will have follow-up visits every 3 months for 2 years, then every 6 months for 3 years.

Eligibility Criteria

Locations