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 III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer
- 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
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- National Cancer Institute (NCI)
- Enrolment target
- 336
- Started
- 5 November 2025
- Main results due
- 31 December 2030
- Study sites
- 335
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria:
* Patients must have pathologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
* Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymph node involvement:
* IIIA (T3aN0M0)
* IIIB (T3bN0M0)
* IIIC1(T3aN1M0, T3bN1M0)
* IIIC2 (T3aN2M0, T3bN2M0)
* IVA (T4aN0M0, T4aN1M0, T4aN2M0) No prior hysterectomy defined as removal of the entire uterus.
* NOTE: prior partial/subtotal hysterectomy for reasons other than cervical cancer are eligible to participate in the study. No plan to perform a hysterectomy as part of initial cervical cancer therapy.
No paraaortic lymph node (PALN) metastases above the T12/L1 interspace.
* Note: Nodal status can be confirmed by imaging (CT, MRI, or PET/CT), fine needle aspirate/core biopsy, extra peritoneal biopsy, laparoscopic biopsy, or lymphadenectomy.
Radiologic definition of lymph node staging:
* N1:
* One or more pelvic lymph nodes with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
* One or more pelvic lymph nodes with short axis diameter of ≥ 10 mm and standardized uptake value maximum (SUVmax) ≥ 2.5 by fludeoxyglucose (FDG)-PET
* N2:
* One or more para-aortic lymph node with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
* One or more para-aortic lymph node with short axis diameter of ≥ 10 mm and SUVmax ≥ 2.5 by FDG-PET
* No prior definitive surgical, radiation, or systemic therapy for cervical cancer
* No prior immunotherapy
* No prior pelvic radiation therapy for any disease
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Not pregnant and not nursing
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
* Platelets ≥ 100,000 cells/mm\^3
* Hemoglobin ≥ 8 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobulin \[Hgb\] ≥ 8 g/dl is acceptable)
* Creatinine clearance (CrCL) of ≥ 50 mL/min by the Cockcroft-Gault formula
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* No active infection requiring parenteral antibiotics
* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed
* No diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior registration
* No active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
* No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(335)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Recruiting
Highlands Oncology Group - Fayetteville
Fayetteville, Arkansas, United States
Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Recruiting
Highlands Oncology Group - Rogers
Rogers, Arkansas, United States
Recruiting
Highlands Oncology Group
Springdale, Arkansas, United States
Recruiting
Kaiser Permanente-Bellflower
Bellflower, California, United States
Recruiting
City of Hope Corona
Corona, California, United States
Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Recruiting
Kaiser Permanente South Bay
Harbor City, California, United States
Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
Recruiting
City of Hope at Irvine Lennar
Irvine, California, United States
Recruiting
Kaiser Permanente-Irvine
Irvine, California, United States
Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, United States
Recruiting
City of Hope Antelope Valley
Lancaster, California, United States
Suspended
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Recruiting
Kaiser Permanente West Los Angeles
Los Angeles, California, United States
Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Recruiting
Kaiser Permanente - Panorama City
Panorama City, California, United States
Recruiting
Salinas Valley Memorial
Salinas, California, United States
Recruiting
Kaiser Permanente-San Diego Zion
San Diego, California, United States
Recruiting
Kaiser Permanente-San Marcos
San Marcos, California, United States
Recruiting
City of Hope South Pasadena
South Pasadena, California, United States
Recruiting
City of Hope Upland
Upland, California, United States
Recruiting
Kaiser Permanente-Woodland Hills
Woodland Hills, California, United States
Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Recruiting
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States
Recruiting
Danbury Hospital
Danbury, Connecticut, United States
Recruiting
Norwalk Hospital
Norwalk, Connecticut, United States
Recruiting
Beebe South Coastal Health Campus
Millville, Delaware, United States
Recruiting
Helen F Graham Cancer Center
Newark, Delaware, United States
Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Recruiting
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States
Recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Recruiting
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, United States
Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Recruiting
Miami Cancer Institute
Miami, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States
Recruiting
Mount Sinai Medical Center
Miami Beach, Florida, United States
Recruiting
Sarasota Memorial Hospital-Venice
N. Venice, Florida, United States
Recruiting
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
North Miami, Florida, United States
Recruiting
Health Central
Ocoee, Florida, United States
Recruiting
Orlando Health Cancer Institute
Orlando, Florida, United States
Recruiting
Memorial Hospital West
Pembroke Pines, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States
Recruiting
Moffitt Cancer Center at SouthShore
Ruskin, Florida, United States
Recruiting
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, United States
Recruiting
FPG - Surgical Oncology Clinics Gynecologic Oncology Surgery
Sarasota, Florida, United States
Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, United States
Recruiting
Sarasota Memorial Health Care Center at University Parkway
Sarasota, Florida, United States
Recruiting
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States
Recruiting
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida, United States
Recruiting
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States
Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, United States
Recruiting
Showing 60 of 335 sites — filter to narrow it down. 325 of the 335 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07061977. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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