Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)

Part of paid clinical trials in Fort Wayne, Indiana.

Sponsor
Infinity Pharmaceuticals, Inc.
Study ID
NCT03980041
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • IPI-549 (eganelisib) — DRUG
    IPI-549 (40mg QD) administered orally in 28-day cycles
  • Nivolumab — DRUG
    Nivolumab (480mg Q4W) administered intravenously (IV) in 28-day cycles
  • Placebos — DRUG
    Placebo administered orally in 28-day cycles

Study Details

The purpose of this study is to measure the effect of IPI-549 in combination with nivolumab when compared to nivolumab monotherapy in advanced urothelial cancer patients.

Key Dates

Start date
Sep 25, 2019
Status verified
Nov 2022
Primary completion
Nov 30, 2020
Completion
Nov 15, 2022

Study Design

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

Arms

  • Experimental: IPI-549 + Nivolumab
    Participants receive IPI-549 orally (PO) daily in combination with nivolumab IV infusion every 4 weeks
  • Active Comparator: Placebo + Nivolumab
    Participants receive placebo orally (PO) daily in combination with nivolumab IV infusion every 4 weeks

Primary Outcome Measure

Objective Response Rate (ORR) per RECISTv1.1 [ Time Frame: First dosing date to date of confirmed disease progression, assessed up to 24 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Parkview PhysiciansFort WayneIndiana46845-
University of MD - Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-
Karmanos Cancer CenterDetroitMichigan48201-
Coborn Cancer CenterSaint CloudMinnesota56303-
Montefiore Medical CenterThe BronxNew York10461-
Bon Secours St. Francis Cancer CenterGreenvilleSouth Carolina29607-
Sarah Cannon Tennessee OncologyNashvilleTennessee37203-

Find similar trials in Fort Wayne, IN

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Parkview Physicians· Fort Wayne, INUniversity of MD - Greenebaum Comprehensive Cancer Center· Baltimore, MDKarmanos Cancer Center· Detroit, MICoborn Cancer Center· Saint Cloud, MNMontefiore Medical Center· The Bronx, NYBon Secours St. Francis Cancer Center· Greenville, SC

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