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NCT04445844 · ClinicalTrials.gov registry record · Phase 2
INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study
A Phase 2 study of Triple Negative Breast Cancer and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by Mridula George, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 2
- Study locations
NCT04445844: Active Phase 2 study of Triple Negative Breast Cancer and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by Mridula George, MD.
NCT04445844 is a Phase 2 study of Triple Negative Breast Cancer and Anatomic Stage IV Breast Cancer AJCC v8 that is active but no longer recruiting, run by Mridula George, MD. The registered enrollment target is 25 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (90% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04445844, a Phase 2 study of Triple Negative Breast Cancer and Anatomic Stage IV Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by Mridula George, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- BIOLOGICAL Retifanlimab
- BIOLOGICAL Pelareorep
Study Locations (2)
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Ohio
- The Ohio State University Stefanie Spielman Comprehensive Breast Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-07-13 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 2 |
What the registry record for NCT04445844 still lists
NCT04445844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (90% lower).
The record links to 5 conditions, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04445844 reports a single indexed study location in New Jersey, Ohio.
Frequently Asked Questions
What is clinical trial NCT04445844 about?
NCT04445844 is a clinical study titled "INCMGA00012 and Pelareorep for the Treatment of Metastatic Triple Negative Breast Cancer, IRENE Study". 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...
What is the current status of trial NCT04445844?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2020-07-13. Estimated completion is 2025-06-30.
What conditions does trial NCT04445844 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8, Locally Advanced Breast Carcinoma.
What interventions are being tested in trial NCT04445844?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Retifanlimab (BIOLOGICAL), Pelareorep (BIOLOGICAL).
Who is sponsoring clinical trial NCT04445844?
This trial is sponsored by Mridula George, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04445844 being conducted?
This trial has 2 study locations across New Jersey, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04445844's enrollment target sits among peer trials
25 101st of 118 higher than 18 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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