Clinical Trial

Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer

Recruiting Phase 3

Summary

This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding induction chemotherapy to the usual treatment of chemotherapy and radiation followed by maintenance may be more effective in treating patients with high risk, locally advanced cervical cancer.

Protocol Amendment History 19 changes

notable Trial sites expanded: 303 -> 310 locations 2026-08-06

notable Trial sites expanded: 296 -> 301 locations 2026-07-28

notable Trial sites expanded: 290 -> 294 locations 2026-07-07

notable Trial sites expanded: 281 -> 285 locations 2026-06-26

notable Trial sites expanded: 271 -> 281 locations 2026-06-24

notable Trial sites expanded: 266 -> 271 locations 2026-06-18

notable Trial sites expanded: 261 -> 266 locations 2026-06-17

notable Trial sites expanded: 253 -> 260 locations 2026-06-12

notable Trial sites expanded: 248 -> 251 locations 2026-05-27

notable Trial sites expanded: 243 -> 248 locations 2026-05-23

notable Trial sites expanded: 235 -> 239 locations 2026-05-14

notable Trial sites expanded: 225 -> 232 locations 2026-05-08

notable Trial sites expanded: 217 -> 222 locations 2026-05-01

notable Trial sites expanded: 202 -> 216 locations 2026-04-25

notable Trial sites expanded: 196 -> 199 locations 2026-04-15

notable Trial sites expanded: 193 -> 196 locations 2026-04-10

notable Trial sites expanded: 188 -> 191 locations 2026-04-04

notable Trial sites expanded: 181 -> 187 locations 2026-03-31

notable Trial sites expanded: 177 -> 181 locations 2026-03-27

Trial Details

NCT Number	NCT07061977
Lead Sponsor	National Cancer Institute (NCI)
Conditions	Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma, Locally Advanced Cervical Squamous Cell Carcinoma, Stage IIIA Cervical Cancer FIGO 2018, Stage IIIB Cervical Cancer FIGO 2018, Stage IIIC1 Cervical Cancer FIGO 2018, Stage IIIC2 Cervical Cancer FIGO 2018, Stage IVA Cervical Cancer FIGO 2018
Enrollment	336 participants
Start Date	2025-11-05
Primary Completion	2030-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-14