Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT03572478
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Rucaparib — DRUG
    600 mg taken by mouth twice daily.
  • Nivolumab — DRUG
    480 mg given by intravenous (IV) infusion every 4 weeks.

Study Details

This is a phase 1/phase 2a study of the combination of immune checkpoint inhibitor (nivolumab) in combination with the PARP inhibitor (rucaparib) for patients with metastatic castration resistant prostate cancer (mCRPC) and metastatic/recurrent endometrial cancer. In the phase 1 portion, the safety of the combination dosing will be determined. If the combination dosing is determined to be safe and feasible, the study will move onto phase 2a. In the phase 2a portion, participants will be randomized to receive either: rucaparib alone, nivolumab alone, or combination therapy (rucaparib and nivolumab).

Key Dates

Start date
Aug 14, 2018
Status verified
Feb 2021
Primary completion
Feb 29, 2020
Completion
Oct 1, 2020

Study Design

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

Arms

  • Experimental: Combination Therapy (Phase 1b Cohort)
    Participants will receive rucaparib plus nivolumab in 4 week cycles.
  • Experimental: Rucaparib (Phase 2b Randomized Cohort)
    Participants randomized to receive rucaparib alone in 4 week cycles.
  • Experimental: Nivolumab (Phase 2b Randomized Cohort)
    Participants randomized to receive nivolumab alone in 4 week cycles.
  • Experimental: Combination Therapy (Phase 2b Randomized Cohort)
    Participants randomized to receive rucaparib plus nivolumab in 4 week cycles. Participants will receive rucaparib alone in cycle 1 and begin nivolumab on day 1 of Cycle 2.

Primary Outcome Measure

Percentage of Participants With Dose Limiting Toxicities (DLT) (Phase 1) [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637-

Find similar trials in Chicago, IL

By condition
Endometrial cancerProstate cancer
By specialty
OncologyGynecologic oncologyWomen's healthProstate oncologyMen's healthUrology
By research site
University of Chicago Medical Center· Chicago, IL

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