Last updated on May 2020

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


Brief description of study

MARIO-3 is a Phase 2 multi-arm combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma, in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC).

Detailed Study Description

MARIO-3 (Macrophage Reprogramming in Immuno-Oncology) is a prospective Phase 2 multi-arm, multicenter, open-label, combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma. IPI-549 will be administered in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC).

This study will enroll approximately 90 treatment-nave patients across the following disease cohorts. Cohort A will be composed of patients with locally advanced and/or metastatic triple-negative breast cancer (TNBC). Cohort B will be composed of patients with locally advanced and/or metastatic renal cell carcinoma (RCC).

The primary objective of MARIO-3 is to evaluate the complete response (CR) rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 following combination treatment with IPI-549 and front-line treatment in patients with TNBC and RCC. Its secondary objectives include evaluation of the safety, objective response rate (ORR), time to CR (TTCR), time to response (TTR), duration of CR (DOCR), duration of response (DOR), and progression-free survival (PFS).

Clinical Study Identifier: NCT03961698

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Pacific Cancer Care

Monterey, CA United States
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Sharp Memorial Hospital

San Diego, CA United States
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UCLA

Santa Monica, CA United States
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University of Colorado

Aurora, CO United States
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Moffitt Cancer Center

Tampa, FL United States
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Cancer Center of Kansas

Wichita, KS United States
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Tennessee Oncology

Nashville, TN United States
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Utah Cancer Specialists

Salt Lake City, UT United States
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Recruitment Status: Open


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