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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT03527264
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab induction — DRUG
    2 doses Nivolumab 240mg IV
  • Cisplatin — DRUG
    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
  • Nivolumab with chemoradiation — DRUG
    Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.
  • Nivolumab maintenance — DRUG
    Nivolumab 480 mg IV every 4 weeks for 2 years

Study Details

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

Key Dates

Start date
Nov 8, 2018
Status verified
Mar 2025
Primary completion
Nov 13, 2020
Completion
Nov 13, 2020

Study Design

Enrollment
4 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1A
    Nivolumab during Chemo/RT with whole pelvic RT
  • Experimental: Cohort 1B
    Nivolumab during Chemo/RT with extended field
  • Experimental: Cohort 2
    Chemoradiation followed by Nivolumab Maintenance
  • Experimental: Cohort 3
    Nivolumab during chemoradiation and then as maintenance

Primary Outcome Measure

Progression Free Survival [ Time Frame: From start of study treatment through date of study completion, an average of 2 years. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Rhode Island HospitalProvidenceRhode Island02903-
Women and Infants HospitalProvidenceRhode Island02905-

Find similar trials in Providence, RI

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Rhode Island Hospital· Providence, RIWomen and Infants Hospital· Providence, RI

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