Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IPI-549 · 1 trial · 4 indications
ORR is defined as best response of complete response (CR) or partial response (PR) as measured by RECIST v1.1. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
| Arm | Type | Description |
|---|---|---|
| IPI-549 + Nivolumab | EXPERIMENTAL | Participants receive IPI-549 orally (PO) daily in combination with nivolumab IV infusion every 4 weeks |
| Placebo + Nivolumab | ACTIVE_COMPARATOR | Participants receive placebo orally (PO) daily in combination with nivolumab IV infusion every 4 weeks |
| Name | Type | Description |
|---|---|---|
| IPI-549 (eganelisib) | DRUG | IPI-549 (40mg QD) administered orally in 28-day cycles |
| Nivolumab | DRUG | Nivolumab (480mg Q4W) administered intravenously (IV) in 28-day cycles |
| Placebos | DRUG | Placebo administered orally in 28-day cycles |
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 reg...
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IPI-549 is an investigational small molecule being studied for the treatment of bladder cancer, specifically advanced urothelial carcinoma. It is being evaluated in combination with nivolumab in patients with advanced urothelial carcinoma, a type of bladder cancer. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
IPI-549 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and efficacy of IPI-549 in combination with other therapies for the treatment of advanced cancers, including bladder cancer.
IPI-549 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, active-controlled study. The drug is investigational and has not been approved by the FDA or any other regulatory agency. It remains in clinical development for the treatment of advanced urothelial carcinoma.
IPI-549 has been studied in a Phase 2 clinical trial with the identifier NCT03980041, titled 'Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)'. This trial enrolled 49 patients and has been completed. The study was conducted in multiple countries, including the United States, Czechia, France, Italy, Poland, Serbia, and Spain.
IPI-549 is a distinct investigational drug and is not known to be the same as any other approved or marketed medication. It is a small molecule being studied for its potential role in cancer treatment, specifically in combination with nivolumab for advanced urothelial carcinoma. No alternative names for IPI-549 have been reported.