OncoMatch/Clinical Trials/NCT05112601
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Is NCT05112601 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ipilimumab and Nivolumab for endometrial adenocarcinoma.
Treatment: Ipilimumab · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: MLH1 loss of expression
MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry
Required: PMS2 loss of expression
MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry
Required: MSH2 loss of expression
MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry
Required: MSH6 loss of expression
MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry
Required: EPCAM loss of expression
MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-CTLA-4 therapy
Patients who received anti-CTLA-4 therapy or other immunotherapeutic agents
Cannot have received: immune checkpoint inhibitor
Exception: Prior anti-PD1/PD-L1 therapy is allowed if given in combination with chemotherapy or radiation therapy in adjuvant or primary metastatic/recurrent settings. Patients must have had a complete response and have disease progression/relapse with treatment-free interval of 12 months or more from last dose of therapy with immune check inhibition
Patients who received prior anti-PD1/PD-L1 therapy and had grade 3-4 or recurring grade 2 immune-related toxicities that led to dose delay or discontinuation of immunotherapy due to those toxicities
Lab requirements
Blood counts
Platelets >= 100,000/mcl; Absolute neutrophil count (ANC) >= 1,500/mcl
Kidney function
Creatinine <= 1.5 x institutional/laboratory upper limit of normal (ULN)
Liver function
Total serum bilirubin level <= 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level <=3 x ULN may be enrolled); AST and ALT <= 3 x ULN
Cardiac function
As clinically indicated, NYHA class 2B or better and QTc interval < 450 msec
Platelets >= 100,000/mcl; ANC >= 1,500/mcl; Creatinine <= 1.5 x ULN; Total serum bilirubin level <= 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level <=3 x ULN may be enrolled); AST and ALT <= 3 x ULN; NYHA class 2B or better and QTc interval < 450 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- University Cancer and Blood Center LLC · Athens, Georgia
- Augusta University Medical Center · Augusta, Georgia
- Saint Alphonsus Cancer Care Center-Boise · Boise, Idaho
- Saint Luke's Cancer Institute - Boise · Boise, Idaho
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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