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Pembrolizumab and Chemotherapy for High-Risk Cervical Cancer

This study is for women with high-risk cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). It compares two treatment approaches. One group receives pembrolizumab (an immunotherapy that helps your immune system fight cancer) and chemotherapy (carboplatin and paclitaxel) first, followed by more pembrolizumab and chemotherapy (cisplatin) with radiation, and then pembrolizumab maintenance. The other group receives the standard treatment of pembrolizumab and chemotherapy (cisplatin) with radiation, followed by pembrolizumab maintenance. The main goal is to see if the first approach improves how long patients live without their cancer growing or coming back (progression-free survival). The study is looking to enroll 336 participants, but its current status is unclear.

Study design
This is an interventional study comparing two treatment approaches for locally advanced cervical cancer. It plans to enroll 336 participants.
What's involved
You would undergo blood sample collection, chest x-rays, and brachytherapy (a type of radiation therapy). You would also receive carboplatin, cisplatin, and pembrolizumab intravenously (IV).
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for progression-free survival for up to 7 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07061977

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
PHASE3Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~336 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBrachytherapyCarboplatinChest RadiographyCisplatinComputed Tomography

At a glance

Recruiting sites
307 of 316 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over From randomization to time of progression or death from any cause, whichever occurs first, or date of last contact if neither progression nor death has occurred, up to 7 years

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

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Cervical Carcinoma

Where it's being run

316 sites across 42 states
Pennsylvania31
New York28
Illinois23
Florida20
Ohio19
California18
North Carolina15
Indiana11

Study leadership

  • Jyoti S Mayadev · PRINCIPAL_INVESTIGATOR · NRG Oncology

Who to contact

Site Public Contact
[email protected]
479-872-8100
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.
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 trial measures

  • Progression free survival (PFS)From randomization to time of progression or death from any cause, whichever occurs first, or date of last contact if neither progression nor death has occurred, up to 7 years

    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 randomization. PFS at 2 years will be estimated using Kaplan-Meier method for each arm.