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NCT05112601 · ClinicalTrials.gov registry record · Phase 2
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
A Phase 2 study of Recurrent Endometrial Carcinoma and Endometrial Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 20
- Study locations
NCT05112601 is a Phase 2 study of Recurrent Endometrial Carcinoma and Endometrial Adenocarcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 81 participants, below the 248-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT05112601, a Phase 2 study of Recurrent Endometrial Carcinoma and Endometrial Adenocarcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA. In 2-3% of endometrial cancers this may be due to a hereditary condition resulted from gene mutation called Lynch Syndrome (previously called hereditary nonpolyposis colorectal cancer or HNPCC). MMR deficient cells usually have many DNA mutations. Tumors that have evidence of mismatch repair deficiency tend to be more sensitive to immunotherapy. There is some evidence that nivolumab with ipilimumab can shrink or stabilize cancers with deficient mismatch repair system. However, it is not known whether this will happen in endometrial cancer; therefore, this study is designed to answer that question. Monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with ipilimumab may be better than nivolumab alone in treating dMMR recurrent endometrial carcinoma.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
Study Locations (20)
Idaho
- Saint Alphonsus Cancer Care Center-Boise - Boise
- Saint Luke's Cancer Institute - Boise - Boise
- Saint Alphonsus Cancer Care Center-Caldwell - Caldwell
- Kootenai Health - Coeur d'Alene - Coeur d'Alene
- Saint Luke's Cancer Institute - Fruitland - Fruitland
- Saint Luke's Cancer Institute - Meridian - Meridian
- Saint Alphonsus Cancer Care Center-Nampa - Nampa
- Saint Luke's Cancer Institute - Nampa - Nampa
- Kootenai Clinic Cancer Services - Post Falls - Post Falls
- Kootenai Clinic Cancer Services - Sandpoint - Sandpoint
Illinois
- University of Illinois - Chicago
- Carle at The Riverfront - Danville
- Carle Physician Group-Effingham - Effingham
- Carle Physician Group-Mattoon/Charleston - Mattoon
- Carle BroMenn Medical Center - Normal
- Carle Cancer Institute Normal - Normal
- Carle Cancer Center - Urbana
Georgia
- University Cancer and Blood Center LLC - Athens
- Augusta University Medical Center - Augusta
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2022-06-02 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05112601
The ClinicalTrials.gov registry entry for NCT05112601 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 248-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (67% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Recurrent Endometrial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05112601 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Idaho, Illinois, Georgia.
Frequently Asked Questions
What is clinical trial NCT05112601 about?
NCT05112601 is a clinical study titled "Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma". This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurr...
What is the current status of trial NCT05112601?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2022-06-02. Estimated completion is 2026-04-30.
What conditions does trial NCT05112601 study?
This clinical trial studies the following conditions: Recurrent Endometrial Carcinoma, Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma.
What interventions are being tested in trial NCT05112601?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05112601?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05112601 being conducted?
This trial has 20 study locations across Alabama, Georgia, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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