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

Conditions

• Breast Cancer
• Renal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IPI-549 (eganelisib) — DRUG
  IPI-549 is an oral, selective inhibitor of phosphoinositide-3-kinase gamma (PI3K-gamma). It is an orally-administered capsule that will be dosed at either 20mg/day, 30mg/day, or 40mg/day to patients in both cohorts A and B depending on the results of the safety run-in phase for each cohort.
• Atezolizumab — DRUG
  Atezolizumab is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1). 840 mg of the drug will be administered intravenously (IV) on days 1 and 15 in combination of each 28-day cycle for patients with TNBC. 1200mg will be administered IV on day 1 of each 21-day cycle to patients with RCC.
• nab-paclitaxel — DRUG
  Nab-paclitaxel is a nanoparticle albumin-bound formulation of paclitaxel (Taxol), a mitotic inhibitor chemotherapy, with less toxicity than solvent-based (sb) paclitaxel and achieves a 33% higher tumor uptake in preclinical models. Nab-paclitaxel will be administered intravenously (IV) at 100 mg/m2 on days 1, 8 and 15 of each 28-day cycle for patients with TNBC.
• Bevacizumab — DRUG
  Bevacizumab is an anti-vascular endothelial growth factor (anti-VEGF) recombinant monoclonal antibody that is approved by the FDA for the treatment of multiple solid tumors in combination with chemotherapy. It will be administered at 15 mg/kg IV on day 1 of each 21-day cycle to patients with RCC.

Study Details

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).

Key Dates

Start date

Dec 17, 2019

Status verified

Aug 2023

Primary completion

Aug 31, 2023

Completion

Aug 31, 2023

Study Design

Enrollment

91 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A (TNBC)
  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.
• Experimental: Cohort B (RCC)
  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.

Primary Outcome Measure

Complete Response (CR) rate (change in target lesion size). [ Time Frame: CR rate assessments will be conducted through month 12 for Cohort A (TNBC) and through month 18 for Cohort B (RCC) until unacceptable toxicity, confirmed progression of disease, withdrawal of consent, or other treatment discontinuation criteria are met. ]

Locations (24)

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