NCT03527264

BrUOG 355: Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer

BrUOG 355: A Pilot Feasibility Study Incorporating Nivolumab to Tailored Radiation Therapy With Concomitant Cisplatin in the Treatment of Patients With Cervical Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of the investigational drug in combination with radiation to learn whether the drug(s) works in treating a specific disease. In this study, researchers are studying three treatment arms, each using standard chemotherapy, with the drug cisplatin and radiation and the drug Nivolumab. Each treatment Arm will test the addition of Nivolumab at a different time point

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab induction	2 doses Nivolumab 240mg IV
DRUG	Cisplatin	40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.
RADIATION	Radiation	Total dose of 45 Gy in 25 fractions at 180 cGy/fx Whole pelvic or extended field
DRUG	Nivolumab with chemoradiation	Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.
DRUG	Nivolumab maintenance	Nivolumab 480 mg IV every 4 weeks for 2 years

Timeline

• Start date: 2018-11-08
• Primary completion: 2020-11-13
• Completion: 2020-11-13
• First posted: 2018-05-17
• Last updated: 2025-04-04
• Results posted: 2022-04-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study