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

NCT03980041 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-11-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

IPI-549 (eganelisib)

IPI-549 (40mg QD) administered orally in 28-day cycles

DRUG

Nivolumab

Nivolumab (480mg Q4W) administered intravenously (IV) in 28-day cycles

DRUG

Placebos

Placebo administered orally in 28-day cycles

Sponsors & Collaborators

Principal Investigators

  • Halle Zhang, PhD, RN · Infinity Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-25
Primary Completion
2020-11-30
Completion
2022-11-15
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Italy
  • Poland
  • Serbia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03980041 on ClinicalTrials.gov