Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma
(MARIO-3 Trial)

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Infinity Pharmaceuticals, Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new pill called IPI-549 combined with other drugs to treat advanced breast and kidney cancers. It aims to block cells that help tumors grow, boosting the body's immune response to fight the cancer.

Eligibility Criteria

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status ≤1.

Life expectancy ≥12 weeks.

Baseline laboratory values must meet the following criteria within 14 days of the first dose:

+15 more

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Cohort B (RCC)Experimental Treatment3 Interventions

IPI-549 in combination with front-line treatment. Cohort B will include two sub-cohorts: Cohorts B1 and B2. Cohort B1: Approximately 15 patients with locally advanced and/or metastatic RCC, with PDL1 positive disease based on IHC defined as IC1/2/3. Cohort B2: Approximately 15 patients with locally advanced and/or metastatic RCC, with PDL1 negative disease based on IHC defined as IC0.

Group II: Cohort A (TNBC)Experimental Treatment3 Interventions

IPI-549 in combination with front-line treatment. Cohort A will include two sub-cohorts: Cohorts A1 and A2. Cohort A1: Approximately 30 patients with locally advanced and/or metastatic TNBC with programmed death-ligand 1 (PDL1) positive disease based on immunohistochemistry (IHC) defined as IC1/2/3. Cohort A2: Approximately 30 patients with locally advanced and/or metastatic TNBC with PDL1 negative disease based on IHC defined as IC0.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: