INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study
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|ClinicalTrials.gov Identifier: NCT04445844|
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : September 16, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|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||Biological: Pelareorep Other: Quality-of-Life Assessment Other: Questionnaire Administration Biological: Retifanlimab||Phase 2|
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.
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||IRENE Study: Phase 2 Study of INCMGA00012 and the Oncolytic Virus Pelareorep in Metastatic Triple Negative Breast Cancer|
|Actual Study Start Date :||July 13, 2020|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
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.
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
- Objective response rate (ORR) [ Time Frame: Within 8 weeks after completion of treatment ]Defined as the percentage of participants having an objective response (complete response [CR] or partial response [PR]), according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The ORR of the drug will be assessed according to Simon's two stage design. The estimated ORR will be compared to the response rate specified in the null hypothesis (6%) using one-sided exact binomial test at type I error 5%. 95% confidence interval (C.I.) will be also reported.
- Incidence of adverse events [ Time Frame: Up to 2 years after completion of treatment ]Will be determined by the number, frequency, duration, and severity of adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v 5.0; laboratory tests and vital signs.
- Progression free survival (PFS) [ Time Frame: From the start of therapy until disease progression, or death due to any cause, assessed up to 2 years after completion of treatment ]Will be determined by the immune complete response (iCR). Will be estimated using Kaplan-Meier product-limit method. The median PFS times with two-sided 95% CIs will be estimated.
- Overall survival (OS) [ Time Frame: From the start of therapy until death due to any cause, assessed up to 2 years after completion of treatment ]Will be estimated using Kaplan-Meier product-limit method. The median OS times with two-sided 95% CIs will be estimated.
- Duration of Response (DOR) [ Time Frame: Up to 2 years after completion of treatment ]Defined as the time from an initial objective response (CR or PR) according to RECIST v 1.1 until disease progression, or death due to any cause, as determined by iCR.
- Quality of life will be evaluated by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30). [ Time Frame: Up to 2 years after completion of treatment ]
- Changes in PD-L1 expression [ Time Frame: Pre and post-treatment ]Will be correlated with treatment response.
- T-cell receptor (TCR) sequencing [ Time Frame: Up to 2 years after completion of treatment ]Assess the role of TCR sequencing in predicting treatment response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445844
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey||Recruiting|
|New Brunswick, New Jersey, United States, 08903|
|Contact: Mridula A. George 732-235-2465 firstname.lastname@example.org|
|Principal Investigator: Mridula A. George|
|United States, Ohio|
|The Ohio State University Stefanie Spielman Comprehensive Breast Center||Recruiting|
|Columbus, Ohio, United States, 43212|
|Contact: Nicole Williams, MD 614-293-0066 email@example.com|
|Principal Investigator: Nicole Williams, MD|
|Principal Investigator:||Mridula A George||Rutgers Cancer Institute of New Jersey|