Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IPI-549 + Nivolumab
Participants receive IPI-549 orally (PO) daily in combination with nivolumab IV infusion every 4 weeks
  • Drug: IPI-549 (eganelisib)
    IPI-549 (40mg QD) administered orally in 28-day cycles
    Other names:
    • IPI549
  • Drug: Nivolumab
    Nivolumab (480mg Q4W) administered intravenously (IV) in 28-day cycles
    Other names:
    • OPDIVO®
Active Comparator
Placebo + Nivolumab
Participants receive placebo orally (PO) daily in combination with nivolumab IV infusion every 4 weeks
  • Drug: Nivolumab
    Nivolumab (480mg Q4W) administered intravenously (IV) in 28-day cycles
    Other names:
    • OPDIVO®
  • Drug: Placebos
    Placebo administered orally in 28-day cycles
    Other names:
    • Placebo

More Details

Status
Completed
Sponsor
Infinity Pharmaceuticals, Inc.

Study Contact

Detailed Description

Study IPI-549-02 is a multi-national, prospective, randomized, active-control Phase II trial to evaluate the efficacy and safety of IPI 549 administered in combination with nivolumab compared to nivolumab monotherapy. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.