Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
NCT ID: NCT03980041
Last Updated: 2022-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2019-09-25
2022-11-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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IPI-549 + Nivolumab
Participants receive IPI-549 orally (PO) daily in combination with nivolumab IV infusion every 4 weeks
IPI-549 (eganelisib)
IPI-549 (40mg QD) administered orally in 28-day cycles
Nivolumab
Nivolumab (480mg Q4W) administered intravenously (IV) in 28-day cycles
Placebo + Nivolumab
Participants receive placebo orally (PO) daily in combination with nivolumab IV infusion every 4 weeks
Nivolumab
Nivolumab (480mg Q4W) administered intravenously (IV) in 28-day cycles
Placebos
Placebo administered orally in 28-day cycles
Interventions
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IPI-549 (eganelisib)
IPI-549 (40mg QD) administered orally in 28-day cycles
Nivolumab
Nivolumab (480mg Q4W) administered intravenously (IV) in 28-day cycles
Placebos
Placebo administered orally in 28-day cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease by CT or MRI as defined by RECIST v1.1
* Disease progression or recurrence after treatment:
* i) With at least 1 platinum-based chemotherapy regimen for the treatment of metastatic (Stage IV) or locally advanced unresectable disease; or
* ii) With disease recurrence within 1 year of completing a platinum-based neoadjuvant or adjuvant therapy
* Subject that have received more than 2 prior lines of chemotherapy must not have liver metastases
* Tumor tissues (archived or new biopsy) must be provided for biomarker analysis
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Blood sample must be provided for mMDSC levels for randomization into the study
Exclusion Criteria
* Any serious or uncontrolled medical disorder that may interfere with study treatment/interpretation
* Prior malignancy active within the previous 3 years except for local or organ confined early stage cancer that has been apparently cured
* Active, known, or suspected autoimmune disease
* A condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 day of study drug administration
* Prior therapy with anti-tumor vaccines, any T cell co-stimulation or checkpoint pathways, or IPI-549
* Prior surgery or gastrointestinal dysfunction that may affect drug absorption
* Past medical history of interstitial lung disease
* History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control
* Positive test for hepatitis B, C or HIV
* Dependent on continuous supplemental oxygen
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Infinity Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Halle Zhang, PhD, RN
Role: STUDY_DIRECTOR
Infinity Pharmaceuticals, Inc.
Locations
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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
The 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
Prague, , 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
Oddzial Chorob Rozrostowych Wojewodzki Szpital
Lodz, , Poland
Dzienny Oddzial Chemioterapii
Racibórz, , Poland
EXAMEN sp
Skorzewo, , Poland
Clinical Centre of Serbia
Belgrade, , Serbia
Institute for Oncology of Vojvodina
Kamenitz, , 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
Seville, , Spain
Countries
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Related Links
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Other Identifiers
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IPI-549-02
Identifier Type: -
Identifier Source: org_study_id
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