Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
Completed · Phase 2 · Has a placebo group
Conditions studied: Bladder Cancer, Urothelial Carcinoma, Solid Tumor, Advanced Cancer
In brief
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.
Key facts
- Study ID
- NCT03980041
- Run by
- Infinity Pharmaceuticals, Inc.
- People needed
- 49
- Starts
- 2019-09-25
- Expected to finish
- 2022-11-15
- Last updated by the study team
- 2022-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
- 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
You may not qualify if…
- Active brain metastases or leptomeningeal metastases
- 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
Where it is running
- 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 — Naples, 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
Full record on ClinicalTrials.gov
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