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

PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

September 25, 2019

Primary Completion Date

November 30, 2020

Study Completion Date

November 15, 2022

Conditions
Bladder CancerUrothelial CarcinomaSolid TumorAdvanced Cancer
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

Trial Locations (29)

8005

Hospital de Sant Creu i Sant Pau, Barcelona

10060

Istituto per la Ricerca e la Cura del Cancro (IRCC), Candiolo

10461

Montefiore Medical Center, The Bronx

13009

Institut Paoli-Calmettes, Marseille

21201

University of MD - Greenebaum Comprehensive Cancer Center, Baltimore

28033

MD Anderson Cancer Center Madrid, Madrid

28034

Hospital Ramón y Cajal, Madrid

28050

Hospital Universitatio HM Sanchinarro, Madrid

29607

Bon Secours St. Francis Cancer Center, Greenville

31300

Institut Claudius Regaud, Toulouse

33011

Hospital Universitario Central de Asturias, Oviedo

37203

Sarah Cannon Tennessee Oncology, Nashville

41013

Hospital Universitario, Seville

46845

Parkview Physicians, Fort Wayne

47104

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

48180

IMQ Zorrotzaurre, Bilbao

48201

Karmanos Cancer Center, Detroit

56303

Coborn Cancer Center, Saint Cloud

59020

Centre Oscar Lambret, Lille

67000

CHU de Strasbourg, Strasbourg

80131

Istituto Nazionale dei Tumori, Napoli

140 59

Onkologicka Klinika, Prague

06189

Centre Antoine Lacassagne, Nice

93-153

Oddzial Chorob Rozrostowych Wojewodzki Szpital, Lodz

47-400

Dzienny Oddzial Chemioterapii, Racibórz

60-185

EXAMEN sp, Skorzewo

11 000

Clinical Centre of Serbia, Belgrade

21 204

Institute for Oncology of Vojvodina, Kamenitz

08907

ICO Institute Catalan of Oncology, Barcelona

Sponsors
All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Infinity Pharmaceuticals, Inc.

INDUSTRY