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

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Mridula George, MD
Study ID
NCT04445844
Phase
PHASE2
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pelareorep — BIOLOGICAL
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Retifanlimab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Jul 13, 2020
Status verified
Apr 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pelareorep, retifanlimab)
    Patients receive pelareorep IV over 60 minutes on days 1, 2, 15, and 16. Patients also receive INCMGA00012 IV over 60 minutes on day 3. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Within 8 weeks after completion of treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
The Ohio State University Stefanie Spielman Comprehensive Breast CenterColumbusOhio43212-

Find similar trials in New Brunswick, NJ

By research site
Rutgers Cancer Institute of New Jersey· New Brunswick, NJThe Ohio State University Stefanie Spielman Comprehensive Breast Center· Columbus, OH

Related Studies