Spots Global Cancer Trial Database for Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
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Trial Identification
Brief Title: Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
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 ID: NCT03980041
Study Description
Brief 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.
Detailed 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-naïve, 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Parkview Physicians, Fort Wayne, Indiana, United States
University of MD - Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States
Karmanos Cancer Center, Detroit, Michigan, United States
Coborn Cancer Center, Saint Cloud, Minnesota, United States
Montefiore Medical Center, Bronx, New York, United States
Bon Secours St. Francis Cancer Center, Greenville, South Carolina, United States
Sarah Cannon Tennessee Oncology, Nashville, Tennessee, United States
Onkologicka Klinika, Praha, , Czechia
Centre Oscar Lambret, Lille, , France
Institut Paoli-Calmettes, Marseille, , France
Centre Antoine Lacassagne, Nice, , France
CHU de Strasbourg, Strasbourg, , France
Institut Claudius Regaud, Toulouse, , France
Istituto per la Ricerca e la Cura del Cancro (IRCC), Candiolo, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Istituto Nazionale dei Tumori, Napoli, , Italy
Dzienny Oddzial Chemioterapii, Racibórz, , Poland
EXAMEN sp, Skorzewo, , Poland
Oddzial Chorob Rozrostowych Wojewodzki Szpital, Łódź, , Poland
Clinical Centre of Serbia, Belgrade, , Serbia
Institute for Oncology of Vojvodina, Sremska Kamenica, , Serbia
ICO Institute Catalan of Oncology, Barcelona, , Spain
Hospital de Sant Creu i Sant Pau, Barcelona, , Spain
IMQ Zorrotzaurre, Bilbao, , Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Universitatio HM Sanchinarro, Madrid, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Universitario, Sevilla, , Spain
Contact Details
Name: Halle Zhang, PhD, RN
Affiliation: Infinity Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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