NRG-GY037: A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab Versus Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer
National Cancer Institute (NCI)
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.
Description
PRIMARY OBJECTIVE: I. To determine whether induction immunotherapy (IO) and chemotherapy prior to concurrent chemoradiation therapy (CCRT) + IO improves progression-free survival (PFS) compared to CCRT+IO alone. SECONDARY OBJECTIVES: I. To assess whether induction IO and chemotherapy prior to CCRT+IO improves the overall survival (OS) compared to CCRT+IO alone. II. To determine the nature and degree of toxicity of induction IO and chemotherapy prior to CCRT + IO as compared to concurrent CCRT+IO as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. III. To…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- RadiationBrachytherapy
Undergo brachytherapy
- DrugCarboplatin
Given IV
- ProcedureChest Radiography
Undergo chest x-ray
- DrugCisplatin
Given IV
- ProcedureComputed Tomography
Undergo CT scan
- RadiationExternal Beam Radiation Therapy
Undergo EBRT
Locations (233)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Kaiser Permanente-BellflowerBellflower, California
- City of Hope CoronaCorona, California
- City of Hope Comprehensive Cancer CenterDuarte, California
- Kaiser Permanente South BayHarbor City, California