NRG-GY037

Clinical Trial Title 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
Trial Status Open to Enrollment
Start Date 01/26/2026
Location All Hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Cervical Cancer
Description 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.
Eligibility Criteria

Eligibility Criteria

Definition of Disease
Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymph node involvement (see Appendix 1 for FIGO and TMN staging):
• IIIA (T3aN0M0)
• IIIB (T3bN0M0)
• IIIC1(T3aN1M0, T3bN1M0)
• IIIC2 (T3aN2M0, T3bN2M0)
• IVA (T4aN0M0, T4aN1M0, T4aN2M0)

Prior Treatment
• No prior definitive surgical, radiation, or systemic therapy for cervical cancer.
• No prior immunotherapy.
• No prior pelvic radiation therapy for any disease.

Required Initial Laboratory Values

Adequate hematologic function defined as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• Platelets ≥ 100,000 cells/mm3
• Hemoglobin ≥ 8 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8 g/dl is acceptable).

Adequate renal function defined as follows:
• Creatinine clearance (CrCL) of ≥50 mL/min by the Cockcroft-Gault formula

CrCl (mL/min) = [140 – age (years)] x weight (kg)/72 x creatinine (mg / dL) {x 0.85 for female patients}

Adequate hepatic function defined as follows:
• 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)
• AST and ALT ≤3 x institutional ULN

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes Study Details | 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 | ClinicalTrials.gov
Principal Investigator Julia Fehniger, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org