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

• Status: Active, not recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.
• Collaborator: Bristol-Myers Squibb
• Treatments: Nivolumab

Criteria

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