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IPI-549 Combined With Front-line Treatments in TNBC or RCC

A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination with Front-line Treatment Regimens in Patients with Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma

  • Clinical Trial Information

    Trial Contact: Jobson, Gillian S; Jarquin-Castillo, Katherine ; Walton, Sherri; Wyatt, Zachary M; Durand, Jennifer

  • IRB No: 1273364

    Protocol Abbrev: TRIO IPI-549-03

    Principal Investigator: Regan Derek Rostorfer, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: MARIO-3

    Treatment: Cohort A (TNBC): IPI-549 orally-administered capsule that will be dosed at either 20mg/day, 30mg/day, or 40mg/day. Atezolizumab 840 mg will be administered intravenously (IV) on days 1 and 15 in combination of each 28-day cycle. Nab-paclitaxel will be administered intravenously (IV) at 100 mg/m2 on days 1, 8 and 15 of each 28-day cycle. Cohort B (RCC): IPI-549 orally-administered capsule that will be dosed at either 20mg/day, 30mg/day, or 40mg/day. Atezolizumab 1200mg will be administered IV on day 1 of each 21-day cycle. Bevacizumab will be administered at 15 mg/kg IV on day 1 of each 21-day cycle.

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT03961698

  • Objective

    To evaluate the complete response (CR) rate per Response Evaluation Criteria in Solid Tumors (RECIST) following combination treatment with IPI-549 and front-line treatment in patients with TNBC and RCC

  • Key Eligibility

    Patients with locally advanced and/or metastatic triple-negative breast cancer (TNBC) PDL1(+) or PDL1(-)
    Patients with locally advanced and/or metastatic renal cell carcinoma (RCC) PDL1(+) or PDL1(-)