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NCT07061977 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Stage IIIA Cervical Cancer FIGO 2018 and Stage IIIB Cervical Cancer FIGO 2018, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 336
- Enrollment target
- 20
- Study locations
NCT07061977: Recruiting Phase 3 study of Stage IIIA Cervical Cancer FIGO 2018 and Stage IIIB Cervical Cancer FIGO 2018, sponsored by National Cancer Institute (NCI).
NCT07061977 is a Phase 3 study of Stage IIIA Cervical Cancer FIGO 2018 and Stage IIIB Cervical Cancer FIGO 2018 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 336 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07061977, a Phase 3 study of Stage IIIA Cervical Cancer FIGO 2018 and Stage IIIB Cervical Cancer FIGO 2018, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 336 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Analysis will be performed using a one-sided log-rank test stratified by factors declared at randomization when (at least) 190 PFS events are observed in both arms. Patients will be grouped by their randomized treatment for intention-to-treat (ITT) analyses, supported by patients in ITT population. Treatment hazard ratio and confidence will be estimated using Cox proportional hazard models specified with a main effect for the randomized treatment assignment and stratified by factors declared at
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- DRUG Cisplatin
- RADIATION Brachytherapy
- PROCEDURE Chest Radiography
Study Locations (20)
California
- City of Hope Corona - Corona
- City of Hope Comprehensive Cancer Center - Duarte
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- City of Hope at Irvine Lennar - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- City of Hope Antelope Valley - Lancaster
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- City of Hope South Pasadena - South Pasadena
- City of Hope Upland - Upland
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Coral Springs - Coral Springs
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
Colorado
- UCHealth University of Colorado Hospital - Aurora
- UCHealth Highlands Ranch Hospital - Highlands Ranch
Connecticut
- Danbury Hospital - Danbury
- Norwalk Hospital - Norwalk
Delaware
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2025-11-05 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 3 |
What NCT07061977 shows while recruiting
NCT07061977 is an interventional study that assigns participants to a tested intervention. The registered 336 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower).
The record links to 8 conditions, with Stage IIIA Cervical Cancer FIGO 2018 appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT07061977 names 20 study sites across 7 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT07061977 about?
NCT07061977 is a clinical study titled "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". 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 tis...
What is the current status of trial NCT07061977?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 336 participants. The study started on 2025-11-05. Estimated completion is 2030-12-31.
What conditions does trial NCT07061977 study?
This clinical trial studies the following conditions: Stage IIIA Cervical Cancer FIGO 2018, Stage IIIB Cervical Cancer FIGO 2018, Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma, Locally Advanced Cervical Squamous Cell Carcinoma.
What interventions are being tested in trial NCT07061977?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Cisplatin (DRUG), Brachytherapy (RADIATION), Chest Radiography (PROCEDURE).
Who is sponsoring clinical trial NCT07061977?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07061977 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07061977's enrollment target sits among peer trials
336 1061st of 2000 higher than 940 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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