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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT03980041

Public ClinicalTrials.gov record NCT03980041. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 8, 2026, 8:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Multicenter, Randomized, Double-Blind, Active-Control Study to Evaluate the Efficacy and Safety of Nivolumab Administered in Combination With IPI-549 Compared to Nivolumab Monotherapy in the Treatment of Patients With Immune Therapy-Naïve, Advanced Urothelial Carcinoma

Study identification

NCT ID
NCT03980041
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Infinity Pharmaceuticals, Inc.
Industry
Enrollment
49 participants

Conditions and interventions

Interventions

  • IPI-549 (eganelisib) Drug
  • Nivolumab Drug
  • Placebos Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 24, 2019
Primary completion
Nov 29, 2020
Completion
Nov 14, 2022
Last update posted
Nov 24, 2022

2019 – 2022

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
Parkview Physicians Fort Wayne Indiana 46845
University of MD - Greenebaum Comprehensive Cancer Center Baltimore Maryland 21201
Karmanos Cancer Center Detroit Michigan 48201
Coborn Cancer Center Saint Cloud Minnesota 56303
Montefiore Medical Center The Bronx New York 10461
Bon Secours St. Francis Cancer Center Greenville South Carolina 29607
Sarah Cannon Tennessee Oncology Nashville Tennessee 37203

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03980041, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 24, 2022 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03980041 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →