Study on INCMGA00012 and Pelareorep for Treating Metastatic Triple Negative Breast Cancer (IRENE Study)

Sponsor: Mridula George, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04445844

Provider View

This clinical trial is testing a new combination of treatments, INCMGA00012 and pelareorep, to see if they can help control triple negative breast cancer that has spread to other parts of the body. The study aims to evaluate the safety and effectiveness of these treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with metastatic triple negative breast cancer, which is a type of breast cancer that does not respond to hormonal therapy. The trial is testing a combination of two treatments: INCMGA00012, a monoclonal antibody that helps the immune system attack cancer cells, and pelareorep, a virus that may help break down cancer cells. The goal is to see if this combination can slow down the growth and spread of the cancer.

Description

The main goals of this study are to see how well the combination of INCMGA00012 and pelareorep works in treating metastatic triple negative breast cancer and to assess the safety and tolerability of this treatment. The study will also look at how long patients live without the cancer getting worse, their overall survival, and how long the treatment response lasts. Additionally, researchers will evaluate the quality of life of participants and explore whether certain biological markers can predict treatment outcomes.

Participants will receive pelareorep through an IV on specific days of a 28-day cycle, along with retifanlimab (INCMGA00012) on another day. This cycle will repeat as long as the cancer does not progress and the treatment is tolerated well. After completing the study treatment, participants will have follow-up visits to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have metastatic or locally advanced triple negative breast cancer that cannot be removed by surgery.
  • Be a woman, either pre-menopausal or post-menopausal, who has received 1-2 prior treatments for metastatic triple negative breast cancer, including at least one chemotherapy.
  • Have a tumor sample available for testing and be willing to undergo biopsies before and during the study.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Have adequate blood counts and organ function as determined by specific tests.
  • Have a life expectancy of at least 3 months.
  • Have measurable disease that can be tracked using standard criteria.
  • If receiving blood thinners, have a stable regimen for at least 14 days before starting the study.
  • If there are brain metastases, they must be treated and stable for at least 28 days before starting the study.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 12 weeks after the last dose.

Exclusion Criteria

  • Have received 4 or more prior treatments for metastatic breast cancer.
  • Have an active autoimmune disease requiring treatment in the past 2 years.
  • Have a psychiatric illness or social situation that would interfere with study participation.
  • Have untreated or active brain metastases, except for small, asymptomatic lesions.
  • Have previously been treated with pelareorep.
  • Have a history of lung disease or active lung inflammation.
  • Have had a stem cell or organ transplant.
  • Have received a live vaccine within 4 weeks of starting the study.
  • Have a serious immunocompromised state or active hepatitis B or C.
  • Be pregnant or breastfeeding.
  • Have received any investigational treatment within 14 days of starting the study.
  • Have a history of severe heart problems within 6 months before starting the study.
  • Have other active cancers, except for certain non-threatening types.
  • Have active alcohol or drug abuse.
  • Be participating in another clinical trial during this study.
  • Have unresolved side effects from previous treatments, except for hair loss or mild anemia.
  • Have had severe immune-related side effects from previous treatments that required stopping the treatment.

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