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

Condition: Bladder Cancer, Urothelial Carcinoma, Solid Tumor, Advanced Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03980041

Sponsor: Infinity Pharmaceuticals, Inc.

Phase: Phase 2


  • Age: minimum 18 Years maximum N/A
  • Gender: All

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

View trial on ClinicalTrials.gov