Trial intelligence / Profile preview

MARIO-3: Eganelisib in Front-line TNBC and RCC

NCT03961698Phase 2

Key facts

Status: Unknown
Start: Dec 2019
Primary completion: Aug 2023
Countries: 1
Sponsor: Infinity Pharmaceuticals, Inc.
Modality: Small Molecules

Drugs: eganelisib
Conditions: triple-negative breast cancer (TNBC)renal cell carcinoma (RCC)

Overview

Phase 2, open-label trial of eganelisib in triple-negative breast cancer (TNBC) and renal cell carcinoma (RCC) (2 cohorts), sponsored by Infinity Pharmaceuticals, Inc. Primary endpoint: Complete Response Rate at 18 months. Status: unknown.

Design

2 arms

Study design: Non-randomizedOpen-label

TNBC Cohort
Patients with locally advanced/metastatic TNBC receiving IPI-549 + Atezolizumab + nab-paclitaxel
RCC Cohort
Patients with locally advanced/metastatic RCC receiving IPI-549 + Atezolizumab + Bevacizumab

Who it enrols

Patients with locally advanced/metastatic TNBC or RCC, ECOG 0-1, no prior systemic therapy for metastatic disease (except neoadjuvant/adjuvant >12 months ago for TNBC). Excludes active brain mets, autoimmune disease, prior checkpoint inhibitors.

Endpoints

Primary

Complete Response Rate18 months

Secondary

Treatment-Emergent Adverse Events90 days post-dose
Serious Adverse Events90 days post-dose
Objective Response Rate18 months
Time to Complete Remission18 months
Time to Response18 months
Duration of Complete Remission18 months
Duration of Response18 months
Progression-Free Survival18 months

Beyond the preview

Go deeper on NCT03961698.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT03961698.