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.
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.
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | September 25, 2019 | Phase 2 | Interventional |
Primary Outcome 1 - Measure: Objective Response Rate (ORR) per RECISTv1.1
Primary Outcome 1 - Time Frame: First dosing date to date of confirmed disease progression, assessed up to 24 months
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
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Halle Zhang, PhD, RN
Role: Study Director
Affiliation: Infinity Pharmaceuticals, Inc.
Name: Miriam Brody, MPH
Phone: 617-453-1142
Email: Miriam.Brody@infi.com
Link: Related Info
