BrUOG 354 Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Brown University
Study ID
NCT03355976
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Clear Cell Adenocarcinoma
  • Extra Renal Origin
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Carcinoma

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    240mg flat dose every 2 weeks
  • Ipilimumab — DRUG
    Ipilimumab 1mg/kg every 6 weeks

Study Details

Preclinical and early-phase clinical data suggest that immune modulation represents a treatment strategy that is worthy of further investigation in relapsed epithelial ovarian cancer. One method by which tumor cells may evade immune surveillance is by activation of the programmed cell death (PD-1) pathway, mediated by expression of PD-1 on the surface of T lymphocytes, which conveys an inhibitory signal after binding to its ligand PD-L1 on the surface of tumor cells. Nivolumab and Ipilimumab have shown activity as monotherapies in solid tumors and very early data suggest that nivolumab may be particularly active for ovarian clear cell carcinoma.(Hamanishi et al., 2015). Given the uniformly poor prognosis for patients with clear cell carcinoma in general, we are interested in formally evaluating this agent in all extra-renal clear cell carcinomas.

Key Dates

Start date
Apr 30, 2018
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
46 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 Nivolumab Ovarian
    Nivolumab 240 mg Day 1 Cycle = 2 weeks
  • Experimental: Arm 2 Nivolumab and Ipilimumab Ovarian
    Nivolumab 240 mg every 2 weeks Ipilimumab 1mg/kg day 1 Cycle=6 weeks
  • Experimental: Arm 1 Nivolumab Extra-renal
    Nivolumab 240 mg Day 1 Cycle = 2 weeks
  • Experimental: Arm 2 Nivolumab and Ipilimumab Extra-renal
    Nivolumab 240 mg every 2 weeks Ipilimumab 1mg/kg day 1 Cycle=6 weeks

Primary Outcome Measure

Proportion of patients who have objective tumor response (complete or partial) by modified RECIST 1.1 in patients with clear cell carcinomas treated with nivolumab or the combination of nivolumab and ipilimumab [ Time Frame: Every 8 weeks during treatment then every 12 weeks in follow-up for up to 2 years (once off study) and until progression. ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Illinois ChicagoChicagoIllinois60612-
Rhode Island HospitalProvidenceRhode Island02903-
The Miriam HospitalProvidenceRhode Island02906-
Women & Infants HospitalProvidenceRhode Island02905-

Find similar trials in Chicago, IL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Illinois Chicago· Chicago, ILRhode Island Hospital· Providence, RIThe Miriam Hospital· Providence, RIWomen & Infants Hospital· Providence, RI

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