Brief Title
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
Official Title
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
Brief 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.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective Response Rate (ORR) per RECISTv1.1
Secondary Outcome
Time to Response (TTR)
Condition
Bladder Cancer
Intervention
IPI-549 (eganelisib)
Study Arms / Comparison Groups
IPI-549 + Nivolumab
Description: Participants receive IPI-549 orally (PO) daily in combination with nivolumab IV infusion every 4 weeks
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
49
Start Date
September 25, 2019
Completion Date
November 15, 2022
Primary Completion Date
November 30, 2020
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Halle Zhang, PhD, RN, ,
Location Countries
Czechia
Location Countries
Czechia
Administrative Informations
NCT ID
NCT03980041
Organization ID
IPI-549-02
Responsible Party
Sponsor
Study Sponsor
Infinity Pharmaceuticals, Inc.
Collaborators
Bristol-Myers Squibb
Study Sponsor
Halle Zhang, PhD, RN, Study Director, Infinity Pharmaceuticals, Inc.
Verification Date
November 2022