NCT04445844

INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study

IRENE Study: Phase 2 Study of INCMGA00012 and the Oncolytic Virus Pelareorep in Metastatic Triple Negative Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Mridula George, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2 study to evaluate the safety and efficacy of the combination of INCMGA00012 and pelareorep and to see how well they work in treating patients with triple negative breast cancer that has spread to other parts of the body (metastatic). INCMGA00012 is a monoclonal antibody that works by attaching to the programmed cell death protein 1 (PD-1) and blocking this pathway, allowing the immune system to recognize and attack the cancer cells. Pelareorep is a type of virus called reovirus which occurs naturally and may break down cancer cells. Giving INCMGA00012 and pelareorep may slow the growth and spread of the cancer to another part of the body.

Detailed description

PRIMARY OBJECTIVES: I. To determine the efficacy of the combination of retifanlimab (INCMGA00012) and pelareorep for patients with metastatic triple negative breast cancer in the second and third line setting. II. To assess the safety, tolerability and feasibility of INCMGA00012 in combination with the oncolytic virus pelareorep for patients with metastatic triple negative breast cancer in the second and third line setting. SECONDARY OBJECTIVES: I. To assess progression free survival (PFS), overall survival (OS) and duration of response (DOR) in patients receiving INCMGA00012 in combination with the oncolytic virus pelareorep for patients with metastatic triple negative breast cancer in the second and third line setting. II. To assess quality of life measures. EXPLORATORY OBJECTIVES: I. To assess whether pre-treatment PD-L1 expression is associated with treatment outcomes. II. To determine if changes in T cell repertoire as measured by T-cell receptor (TCR) sequencing is predictive of treatment outcomes. OUTLINE: Patients receive pelareorep intravenously (IV) over 60 minutes on days 1, 2, 15, and 16. Patients also receive retifanlimab IV over 60 minutes on day 3. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 and 90 days, then every 6 months for up to 2 years.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Locally Advanced Breast Carcinoma
• Metastatic Triple-Negative Breast Carcinoma
• Prognostic Stage IV Breast Cancer AJCC v8
• Triple-negative Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pelareorep	Given IV
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
BIOLOGICAL	Retifanlimab	Given IV

Timeline

• Start date: 2020-07-13
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2020-06-24
• Last updated: 2025-04-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study