September 16 2025
We are excited to announce the upcoming activation of NRG-GY037, a pivotal Phase III randomized trial for patients with high-risk, locally advanced cervical cancer. The study is set to open for enrollment late 2025.
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.” NRG-GY037 will evaluate whether adding induction chemotherapy and immunotherapy (carboplatin, paclitaxel, and pembrolizumab) prior to standard chemoradiation with cisplatin and pembrolizumab can further improve outcomes. All patients will receive concurrent and maintenance pembrolizumab, consistent with the FDA-approved treatment pathway for this patient population.
“Recent large randomized trials have demonstrated the promise of immunotherapy and induction chemotherapy in improving outcomes for patients with high-risk cervical cancer,” said Jyoti Mayadev, MD, of the University of California, San Diego, and Principal Investigator for NRG-GY037. “This trial is a major step forward, designed to explore the synergy of induction therapy prior to chemoradiation, with the goal of improving survival for this high-risk population.”
Study Highlights:
- Target Accrual: 336 patients
- Eligibility: Patients with FIGO stage T3 or T4 cervical cancer, with or without nodal involvement, eligible for treatment with chemoradiation and pembrolizumab per current FDA label.
- Primary Endpoint:
- Progression-Free Survival (PFS): Comparison of induction IO + chemotherapy → CCRT + IO vs. CCRT + IO alone
- Secondary Endpoints:
- Overall Survival (OS)
- Toxicity (CTCAE v5.0) of the induction approach compared to standard care
Follow-Up Schedule:
After completing therapy, patients will be followed every 3 months for 2 years, then every 6 months for 3 years.
This study builds on the momentum of recent immunotherapy advances in cervical cancer and represents a significant opportunity to redefine first-line therapy for patients with high-risk, locally advanced disease.
We encourage sites to consider enrolling eligible patients onto this trial, and to reach out with any questions!
More Study Information
Learn more about this trial (NCT07061977) at ClinicalTrials.gov