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Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
NCT05112601 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05112601 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Idaho, Illinois, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05112601?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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