Last updated on May 2020

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Urologic Cancer | bladder disorder | Transitional cell carcinoma | Solid Tumor | Urothelial Carcinoma | Bladder Disorders | Advanced Cancer | bladder cancer | Bladder Carcinoma | urinary tract neoplasm | Urothelial Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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