Trials / Completed
CompletedNCT03980041
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Infinity Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IPI-549 (eganelisib) | IPI-549 (40mg QD) administered orally in 28-day cycles |
| DRUG | Nivolumab | Nivolumab (480mg Q4W) administered intravenously (IV) in 28-day cycles |
| DRUG | Placebos | Placebo administered orally in 28-day cycles |
Timeline
- Start date
- 2019-09-25
- Primary completion
- 2020-11-30
- Completion
- 2022-11-15
- First posted
- 2019-06-10
- Last updated
- 2022-11-25
Locations
29 sites across 7 countries: United States, Czechia, France, Italy, Poland, Serbia, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03980041. Inclusion in this directory is not an endorsement.