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

NCT03527264 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-04-04

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Rhode Island Hospital

    collaborator OTHER

  • The Miriam Hospital

    collaborator OTHER

  • Women and Infants Hospital of Rhode Island

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Brown University

    lead OTHER

Principal Investigators

  • Don Dizon, MD · Brown University Oncology Research Group (BrUOG)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2020-11-13
Completion
2020-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03527264 on ClinicalTrials.gov