Actively Recruiting
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Led by National Cancer Institute (NCI) · Updated on 2026-04-21
81
Participants Needed
137
Research Sites
204 weeks
Total Duration
On this page
Sponsors
N
National Cancer Institute (NCI)
Lead Sponsor
N
NRG Oncology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with measurable or non-measurable recurrent endometrial cancer
- Measurable disease defined by RECIST 1.1 criteria with lesions >= 10 mm by CT or MRI
- Non-measurable disease includes small lesions, ascites, pleural effusion, or certain abnormalities on imaging
- Endometrial cancer must have deficient mismatch repair confirmed by immunohistochemistry or microsatellite instability testing
- Histologic confirmation of primary tumor including specific endometrial carcinoma types
- Patients may have had 1-2 prior systemic therapies; prior anti-PD1/PD-L1 allowed with conditions
- Prior radiation therapy completed at least 4 weeks before registration
- Prior hormonal therapy discontinued at least 3 weeks before registration
- Other prior therapies discontinued at least 4 weeks before registration (6 weeks for certain drugs)
- Age 18 years or older
- ECOG Performance Status of 0, 1, or 2
- Adequate blood counts and organ function
- Oxygen saturation adequate and thyroid function normal if tested
- Recovery from recent surgery, radiotherapy, or chemotherapy
- Cardiac function assessment with corrected QT interval < 450 msec
- Women of childbearing potential must use contraception and have negative pregnancy test
- Patients with certain prior or concurrent malignancies allowed
- HIV-infected patients on effective therapy with undetectable viral load allowed
- Patients with controlled hepatitis B or cured hepatitis C allowed
- Patients with treated and stable brain metastases allowed
- Informed consent obtained
- Patients with certain autoimmune conditions controlled or without active disease allowed
You will not qualify if you...
- Diagnosis of endometrial serous carcinoma or carcinosarcoma
- Prior anti-PD1/PD-L1 therapy with severe or recurring immune-related toxicities causing treatment delay or stop
- Prior anti-CTLA-4 or other immunotherapy agents
- Chronic steroid therapy above 10 mg prednisone or equivalent, except certain local uses
- Current immunosuppressive therapy except specific exceptions
- Active or history of autoimmune diseases affecting vital organs or requiring immunosuppressive treatment
- Known immune impairment affecting response to anti-CTLA-4 therapy
- Uncontrolled illness including active infection, lung disease, heart conditions, arrhythmias, or psychiatric/social issues limiting compliance
- Pregnant or unwilling to stop nursing
- Prior therapy targeting T-cell co-stimulation or immune checkpoint pathways
- History of severe allergic reactions to similar monoclonal antibodies including nivolumab or ipilimumab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 137 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
University Cancer and Blood Center LLC
Athens, Georgia, United States, 30607
Actively Recruiting
3
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Actively Recruiting
4
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
Suspended
5
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
6
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, United States, 83605
Suspended
7
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States, 83814
Actively Recruiting
8
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States, 83619
Actively Recruiting
9
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States, 83642
Actively Recruiting
10
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, United States, 83687
Suspended
11
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States, 83687
Actively Recruiting
12
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States, 83854
Actively Recruiting
13
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States, 83864
Actively Recruiting
14
University of Illinois
Chicago, Illinois, United States, 60612
Suspended
15
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
16
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
17
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
18
Carle BroMenn Medical Center
Normal, Illinois, United States, 61761
Actively Recruiting
19
Carle Cancer Institute Normal
Normal, Illinois, United States, 61761
Actively Recruiting
20
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
21
IU Health North Hospital
Carmel, Indiana, United States, 46032
Actively Recruiting
22
Northwest Cancer Center - Crown Point
Crown Point, Indiana, United States, 46307
Actively Recruiting
23
Northwest Oncology LLC
Dyer, Indiana, United States, 46311
Actively Recruiting
24
Northwest Cancer Center - Hobart
Hobart, Indiana, United States, 46342
Actively Recruiting
25
Saint Mary Medical Center
Hobart, Indiana, United States, 46342
Actively Recruiting
26
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
27
Saint Catherine Hospital
Indianapolis, Indiana, United States, 46312
Actively Recruiting
28
The Community Hospital
Munster, Indiana, United States, 46321
Actively Recruiting
29
Women's Diagnostic Center - Munster
Munster, Indiana, United States, 46321
Actively Recruiting
30
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, United States, 46383
Actively Recruiting
31
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
32
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
33
UofL Health Medical Center Northeast
Louisville, Kentucky, United States, 40245
Actively Recruiting
34
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, United States, 04074
Actively Recruiting
35
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Actively Recruiting
36
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
37
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
38
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
39
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Actively Recruiting
40
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, United States, 49009
Actively Recruiting
41
Trinity Health Muskegon Hospital
Muskegon, Michigan, United States, 49444
Actively Recruiting
42
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, United States, 49120
Actively Recruiting
43
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, United States, 49444
Actively Recruiting
44
Corewell Health Reed City Hospital
Reed City, Michigan, United States, 49677
Actively Recruiting
45
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Actively Recruiting
46
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, United States, 49085
Actively Recruiting
47
Munson Medical Center
Traverse City, Michigan, United States, 49684
Actively Recruiting
48
University of Michigan Health - West
Wyoming, Michigan, United States, 49519
Actively Recruiting
49
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
50
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States, 56636
Actively Recruiting
51
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Actively Recruiting
52
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Actively Recruiting
53
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Actively Recruiting
54
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States, 55746
Actively Recruiting
55
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
56
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
57
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
58
United Hospital
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
59
Essentia Health Sandstone
Sandstone, Minnesota, United States, 55072
Actively Recruiting
60
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Actively Recruiting
61
Essentia Health Virginia Clinic
Virginia, Minnesota, United States, 55792
Actively Recruiting
62
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65212
Actively Recruiting
63
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
64
Community Hospital of Anaconda
Anaconda, Montana, United States, 59711
Actively Recruiting
65
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
Actively Recruiting
66
Saint Vincent Frontier Cancer Center
Billings, Montana, United States, 59102
Actively Recruiting
67
Intermountain Health West End Clinic
Billings, Montana, United States, 59106
Actively Recruiting
68
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States, 59715
Actively Recruiting
69
Benefis Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Actively Recruiting
70
Logan Health Medical Center
Kalispell, Montana, United States, 59901
Actively Recruiting
71
Community Medical Center
Missoula, Montana, United States, 59804
Actively Recruiting
72
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Actively Recruiting
73
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89106
Actively Recruiting
74
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
75
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Active, Not Recruiting
76
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
77
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
78
Wilmot Cancer Institute at Webster
Webster, New York, United States, 14580
Actively Recruiting
79
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
80
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, United States, 27607
Actively Recruiting
81
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States, 58103
Actively Recruiting
82
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States, 44122
Actively Recruiting
83
Miami Valley Hospital South
Centerville, Ohio, United States, 45459
Actively Recruiting
84
Geauga Hospital
Chardon, Ohio, United States, 44024
Actively Recruiting
85
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
Actively Recruiting
86
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
87
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Actively Recruiting
88
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
89
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
90
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
91
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States, 44060
Actively Recruiting
92
University Hospitals Parma Medical Center
Parma, Ohio, United States, 44129
Actively Recruiting
93
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, United States, 44145
Actively Recruiting
94
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
95
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
Actively Recruiting
96
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, United States, 97914
Suspended
97
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
98
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
99
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, United States, 15009
Actively Recruiting
100
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, United States, 16001
Actively Recruiting
101
UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township, Pennsylvania, United States, 16066
Actively Recruiting
102
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States, 16505
Actively Recruiting
103
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, United States, 16121
Actively Recruiting
104
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Actively Recruiting
105
IRMC Cancer Center
Indiana, Pennsylvania, United States, 15701
Actively Recruiting
106
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, United States, 15901
Actively Recruiting
107
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
Actively Recruiting
108
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, United States, 17050
Actively Recruiting
109
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
110
UPMC Hillman Cancer Center in Coraopolis
Moon Township, Pennsylvania, United States, 15108
Actively Recruiting
111
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant, Pennsylvania, United States, 15666
Actively Recruiting
112
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania, United States, 15642
Actively Recruiting
113
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania, United States, 15065
Actively Recruiting
114
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, United States, 16105
Actively Recruiting
115
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
116
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
Actively Recruiting
117
UPMC-Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
118
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
119
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
Actively Recruiting
120
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States, 15243
Actively Recruiting
121
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
Actively Recruiting
122
UPMC Cancer Center-Washington
Washington, Pennsylvania, United States, 15301
Actively Recruiting
123
UPMC West Mifflin-Cancer Center Jefferson
West Mifflin, Pennsylvania, United States, 15122
Actively Recruiting
124
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
Actively Recruiting
125
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Actively Recruiting
126
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
127
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
128
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, United States, 75080
Actively Recruiting
129
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
130
Henrico Doctor's Hospital
Richmond, Virginia, United States, 23229
Actively Recruiting
131
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
132
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States, 98026
Actively Recruiting
133
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Actively Recruiting
134
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Active, Not Recruiting
135
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122
Actively Recruiting
136
Duluth Clinic Ashland
Ashland, Wisconsin, United States, 54806
Actively Recruiting
137
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, United States, 54806
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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