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

  • STATUS
    Recruiting
  • End date
    Nov 27, 2022
  • participants needed
    160
  • sponsor
    Infinity Pharmaceuticals, Inc.
Updated on 21 April 2021
cancer
measurable disease
carcinoma
chemotherapy regimen
nivolumab
transitional cell carcinoma
platinum-based chemotherapy
advanced urothelial carcinoma
immunomodulator

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.

Description

Study IPI-549-02 is a multi-national, prospective, randomized, active-control Phase II trial to evaluate the efficacy and safety of IPI 549 administered in combination with nivolumab compared to nivolumab monotherapy.

The study will enroll approximately 160 checkpoint-nave, advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy. Patients will be randomized 2:1 to receive intravenous (IV) nivolumab 480 mg every 4 weeks (Q4W) in combination with oral (PO) IPI 549 40 mg once daily (QD) or IV nivolumab 480 mg Q4W in combination with placebo PO QD.

Eligible patients who have confirmed progression of disease during treatment with nivolumab monotherapy may crossover to the combination treatment arm.

Details
Condition urinary tract neoplasm, bladder cancer, bladder disorder, Transitional cell carcinoma, Solid Tumors, Solid Tumor, Advanced Cancer, Solid Neoplasm, Urothelial Cancer, Solid Tumour, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, Urothelial Carcinoma, cancer advanced, carcinoma of the bladder, bladder tumor
Treatment placebos, Nivolumab, IPI-549, IPI-549 (eganelisib)
Clinical Study IdentifierNCT03980041
SponsorInfinity Pharmaceuticals, Inc.
Last Modified on21 April 2021

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