AzTrials
AzTrials

Endometrial AdenocarcinomaPhase 2NCT05112601

Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Ipilimumab in people with Endometrial Adenocarcinoma and Endometrial Clear Cell Adenocarcinoma, run by National Cancer Institute (NCI) at 138 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Biospecimen Collection, Computed Tomography and Ipilimumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
138 sitesUnited States
Study dates
2 Jun 2022to 30 Jul 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with measurable or non-measurable (detectable) recurrent endometrial cancer
  • Measurable disease will be defined and monitored by RECIST v 1.1. Measurable disease is defined per RECIST 1.1 criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI
  • Non-measurable (detectable) disease in a patient is defined in this protocol per RECIST 1.1 criteria as one who does not have measurable disease but has at least one of the following conditions:
  • All other lesions (or sites of disease), including small lesions (longest diameter <10 mm or pathological lymph nodes with >= 10 to < 15 mm short axis), are considered non-measurable disease
  • Ascites and/or pleural effusion attributed to tumor
  • Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions
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  • Patients must have endometrial cancer with deficient mismatch repair system. All patients must have institutional immunohistochemistry (IHC) and/or microsatellite instability (MSI) testing to determine mismatch repair (MMR) status. MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry and/or presence of microsatellite instability high using the National Cancer Institute (NCI)-5plex and Promega v1.2 assays, or institutional standards (e.g. next-generation sequencing [NGS] panel)
  • Method(s) of detection of MMR deficiency will be recorded for each patient. An institutional pathology report, and additional reports if available, documenting these results must be submitted. Patients with "equivocal" results on MMR testing by immunohistochemistry may be eligible if they have documented evidence of microsatellite instability by MSI testing or by next generation sequencing assays. MMR testing by IHC may be used to resolve equivocal/indeterminate MSI results
  • Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, mucinous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)
  • Patients may have received 1-2 prior lines of systemic therapy:
  • 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 may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration
  • Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to registration
  • Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C)
  • Age >= 18
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Platelets >= 100,000/mcl
  • Absolute neutrophil count (ANC) >= 1,500/mcl
  • Creatinine =< 1.5 x institutional/laboratory upper limit of normal (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)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN
  • Adequate oxygen saturation via pulse oximeter (CTCAE v.5.0 hypoxia < grade 2 within 28 days prior to registration)
  • Thyroid-stimulating hormone (TSH) within normal limits (TSH < ULN allowed in euthyroid patients on thyroid replacement therapy). TSH testing is only required if clinically indicated
  • Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy. At least 4 weeks must have elapsed since major surgery
  • As clinically indicated, patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better and have a corrected QT (QTc) interval < 450 msec
  • The effects of nivolumab, and ipilimumab on the developing human fetus are unknown. For this reason and because nivolumab and ipilimumab are known to be teratogenic, women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 5 months after the last dose of investigational drug. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception
  • WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
  • Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and the patient is stable off steroids for at least one month
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
  • Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible
  • Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible

Who cannot join

  • Patients with a diagnosis of endometrial serous carcinoma or carcinosarcoma
  • 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
  • Patients who received anti-CTLA-4 therapy or other immunotherapeutic agents
  • Patients on chronic steroid therapy except those on replacement therapy at a daily dose of 10mg or less prednisone or equivalent
  • Patients on immunosuppressive therapy, with the exception of:
  • Intra-nasal, inhaled, topical or local steroid injections
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  • Premedication for hypersensitivity reaction
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease
  • Patients with known immune impairment who may be unable to respond to anti-CTLA-4 antibody
  • Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Women who are pregnant or unwilling to discontinue nursing
  • Prior therapy with CTLA-4 inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, and/or ipilimumab including severe hypersensitivity reactions to any monoclonal antibody

Trial locations and contacts

138 sites in 1 country. Contact the study team or a site near you to ask about taking part.

138 sites in 1 country

United States138 sites, 120 recruiting

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

    Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu

    Carolyn Y. Muller

    Recruiting

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • University Cancer and Blood Center LLC

    Athens, Georgia, 30607

    Suspended

  • Augusta University Medical Center

    Augusta, Georgia, 30912

    Site Public Contact, 706-721-2388, ga_cares@augusta.edu

    Bunja J. Rungruang

    Recruiting

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Amy Armstrong

    Recruiting

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Alexander B. Olawaiye

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

    Site Public Contact, 800-648-6274

    Megan Petersen

    Recruiting

  • Intermountain Health West End Clinic

    Billings, Montana, 59106

    Site Public Contact, 406-238-6685

    Megan Petersen

    Recruiting

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

    Site Public Contact, gingerreeves@uabmc.edu

    Michael D. Toboni

    Recruiting

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

    Suspended

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Dan S. Zuckerman

    Recruiting

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Active, not recruiting

  • UPMC Hillman Cancer Center at Butler Health System

    Butler, Pennsylvania, 16001

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Alexander B. Olawaiye

    Recruiting

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

    Suspended

  • IU Health North Hospital

    Carmel, Indiana, 46032

    Suspended

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

    Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org

    Michael S. Guy

    Recruiting

  • Geauga Hospital

    Chardon, Ohio, 44024

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Amy Armstrong

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Linda R. Duska

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Suspended

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

    Active, not recruiting

  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Amy Armstrong

    Recruiting

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Peter G. Rose

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Peter G. Rose

    Recruiting

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

    Site Public Contact, 573-882-7440

    Arwa M. Mohammad

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Floor Backes

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Adrianne Mallen

    Recruiting

  • UPMC Hillman Cancer Center - Passavant - Cranberry

    Cranberry Township, Pennsylvania, 16066

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Alexander B. Olawaiye

    Recruiting

  • Northwest Cancer Center - Crown Point

    Crown Point, Indiana, 46307

    Site Public Contact, 219-836-6879, CancerResearch@powershealth.org

    Pratima Chalasani

    Recruiting

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

    Site Public Contact, 214-590-5582, canceranswerline@UTSouthwestern.edu

    David S. Miller

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    David S. Miller

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Pratima Chalasani

    Recruiting

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Site Public Contact, 888-275-3853

    Angeles A. Secord

    Recruiting

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

    Site Public Contact, 219-924-8178

    Pratima Chalasani

    Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Adrianne Mallen

    Recruiting

  • Minnesota Oncology - Edina

    Edina, Minnesota, 55435

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Adrianne Mallen

    Recruiting

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Dan S. Zuckerman

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Pratima Chalasani

    Recruiting

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Alexander B. Olawaiye

    Recruiting

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Alexander B. Olawaiye

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

    Suspended

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Dan S. Zuckerman

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

    Suspended

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

    Site Public Contact, 724-838-1900

    Alexander B. Olawaiye

    Recruiting

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

    Site Public Contact, 218-786-3308

    Bret E. Friday

    Recruiting

  • Northwest Cancer Center - Hobart

    Hobart, Indiana, 46342

    Site Public Contact, 219-947-1795

    Pratima Chalasani

    Recruiting

  • Saint Mary Medical Center

    Hobart, Indiana, 46342

    Site Public Contact, 219-836-6875, CancerResearch@COMHS.org

    Pratima Chalasani

    Recruiting

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Alexander B. Olawaiye

    Recruiting

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Site Public Contact, 317-278-5632, iutrials@iu.edu

    Jessica E. Parker

    Recruiting

  • Saint Catherine Hospital

    Indianapolis, Indiana, 46312

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Pratima Chalasani

    Recruiting

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

    Suspended

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Dan S. Zuckerman

    Recruiting

  • UPMC-Johnstown/John P. Murtha Regional Cancer Center

    Johnstown, Pennsylvania, 15901

    Site Public Contact, 814-534-4724

    Alexander B. Olawaiye

    Recruiting

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Beacon Kalamazoo Cancer Center

    Kalamazoo, Michigan, 49009

    Suspended

  • Logan Health Medical Center

    Kalispell, Montana, 59901

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89106

    Site Public Contact, 702-851-4672

    Nicola M. Spirtos

    Recruiting

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

    Site Public Contact, 502-562-3429

    Jason A. Chesney

    Recruiting

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

    Site Public Contact, 502-852-2755, ctoinfo@louisville.edu

    Jason A. Chesney

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Pratima Chalasani

    Recruiting

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

    Site Public Contact, 866-223-8100, TaussigResearch@ccf.org

    Peter G. Rose

    Recruiting

  • UPMC Cancer Center at UPMC McKeesport

    McKeesport, Pennsylvania, 15132

    Site Public Contact, 412-647-8073

    Alexander B. Olawaiye

    Recruiting

  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    Mechanicsburg, Pennsylvania, 17050

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Alexander B. Olawaiye

    Recruiting

  • UH Seidman Cancer Center at Lake Health Mentor Campus

    Mentor, Ohio, 44060

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Amy Armstrong

    Recruiting

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Dan S. Zuckerman

    Recruiting

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Adrianne Mallen

    Recruiting

  • Community Medical Center

    Missoula, Montana, 59804

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • UPMC Hillman Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Alexander B. Olawaiye

    Recruiting

  • UPMC Hillman Cancer Center in Coraopolis

    Moon Township, Pennsylvania, 15108

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Alexander B. Olawaiye

    Recruiting

  • UPMC Hillman Cancer Center - Part of Frick Hospital

    Mount Pleasant, Pennsylvania, 15666

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Alexander B. Olawaiye

    Recruiting

  • The Community Hospital

    Munster, Indiana, 46321

    Site Public Contact, 219-836-3349

    Pratima Chalasani

    Recruiting

  • Women's Diagnostic Center - Munster

    Munster, Indiana, 46321

    Site Public Contact, 219-934-8869, mnicholson@comhs.org

    Pratima Chalasani

    Recruiting

  • Trinity Health Muskegon Hospital

    Muskegon, Michigan, 49444

    Suspended

  • Arnold Palmer Cancer Center Medical Oncology Norwin

    N. Huntingdon, Pennsylvania, 15642

    Site Public Contact, 412-864-7716, ClinicalResearchServices@upmc.edu

    Alexander B. Olawaiye

    Recruiting

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

    Suspended

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Dan S. Zuckerman

    Recruiting

  • UPMC Cancer Center-Natrona Heights

    Natrona Heights, Pennsylvania, 15065

    Site Public Contact, 724-230-3030

    Alexander B. Olawaiye

    Recruiting

  • UPMC Hillman Cancer Center - New Castle

    New Castle, Pennsylvania, 16105

    Site Public Contact, 412-389-5208, haneydl@upmc.edu

    Alexander B. Olawaiye

    Recruiting

  • Corewell Health Lakeland Hospitals - Niles Hospital

    Niles, Michigan, 49120

    Site Public Contact, 616-391-1230

    Kathleen Y. Butler

    Recruiting

  • Carle BroMenn Medical Center

    Normal, Illinois, 61761

    Site Public Contact, 800-446-5532, Research@Carle.com

    Pratima Chalasani

    Recruiting

  • Carle Cancer Institute Normal

    Normal, Illinois, 61761

    Site Public Contact, 800-446-5532, Research@Carle.com

    Pratima Chalasani

    Recruiting

  • Cancer and Hematology Centers of Western Michigan - Norton Shores

    Norton Shores, Michigan, 49444

    Suspended

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Christina Washington

    Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Site Public Contact, 402-354-5144

    Brent J. Tierney

    Recruiting

  • Saint Alphonsus Cancer Care Center-Ontario

    Ontario, Oregon, 97914

    Suspended

  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Amy Armstrong

    Recruiting

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

    Site Public Contact, 412-647-2811

    Alexander B. Olawaiye

    Recruiting

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

    Site Public Contact, 412-784-4900

    Alexander B. Olawaiye

    Recruiting

  • UPMC-Mercy Hospital

    Pittsburgh, Pennsylvania, 15219

    Site Public Contact, 800-533-8762

    Alexander B. Olawaiye

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Alexander B. Olawaiye

    Recruiting

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

    Site Public Contact, 412-367-6454

    Alexander B. Olawaiye

    Recruiting

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

    Site Public Contact, 412-502-3920

    Alexander B. Olawaiye

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Dan S. Zuckerman

    Recruiting

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

    Site Public Contact, 401-274-1122

    Cara A. Mathews

    Recruiting

  • Duke Women's Cancer Care Raleigh

    Raleigh, North Carolina, 27607

    Site Public Contact, 919-785-4878

    Angeles A. Secord

    Recruiting

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

    Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu

    David S. Miller

    Recruiting

  • Henrico Doctor's Hospital

    Richmond, Virginia, 23229

    Site Public Contact, 804-591-4152

    Andrew S. Kennedy

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Active, not recruiting

  • University of Rochester

    Rochester, New York, 14642

    Site Public Contact, 585-275-5830

    Rachael Turner

    Recruiting

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    Saint Joseph, Michigan, 49085

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Adrianne Mallen

    Recruiting

  • Regions Hospital

    Saint Paul, Minnesota, 55101

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Adrianne Mallen

    Recruiting

  • United Hospital

    Saint Paul, Minnesota, 55102

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Adrianne Mallen

    Recruiting

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Essentia Health Sandstone

    Sandstone, Minnesota, 55072

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Leslie S. Bradford

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Active, not recruiting

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122

    Site Public Contact, 206-215-2343, PCRC-NCORP@Swedish.org

    Dan S. Zuckerman

    Recruiting

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

    Site Public Contact, 814-676-7900

    Alexander B. Olawaiye

    Recruiting

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

    Site Public Contact, 952-993-1517, mmcorc@healthpartners.com

    Adrianne Mallen

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Premal H. Thaker

    Recruiting

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

    Site Public Contact, 315-464-5476

    Mary J. Cunningham

    Recruiting

  • Munson Medical Center

    Traverse City, Michigan, 49684

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

    Active, not recruiting

  • Carle Cancer Center

    Urbana, Illinois, 61801

    Site Public Contact, 800-446-5532, Research@carle.com

    Pratima Chalasani

    Recruiting

  • Northwest Cancer Center - Valparaiso

    Valparaiso, Indiana, 46383

    Site Public Contact, 219-836-6875, CancerResearch@COMHS.org

    Pratima Chalasani

    Recruiting

  • Essentia Health Virginia Clinic

    Virginia, Minnesota, 55792

    Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org

    Bret E. Friday

    Recruiting

  • UPMC Cancer Center-Washington

    Washington, Pennsylvania, 15301

    Site Public Contact, 412-339-5294, Roster@nrgoncology.org

    Alexander B. Olawaiye

    Recruiting

  • Wilmot Cancer Institute at Webster

    Webster, New York, 14580

    Site Public Contact, WCICTOresearch@urmc.rochester.edu

    Rachael Turner

    Recruiting

  • UPMC West Mifflin-Cancer Center Jefferson

    West Mifflin, Pennsylvania, 15122

    Site Public Contact, 412-653-8100

    Alexander B. Olawaiye

    Recruiting

  • UH Seidman Cancer Center at Saint John Medical Center

    Westlake, Ohio, 44145

    Site Public Contact, 800-641-2422, CTUReferral@UHhospitals.org

    Amy Armstrong

    Recruiting

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of Nivolumab and Ipilimumab Compared to Nivolumab Monotherapy in Patients With Deficient Mismatch Repair System 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 (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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess efficacy in terms of progression-free survival (PFS) for immunotherapy with dual immune checkpoint blockade (nivolumab/ipilimumab) versus (vs.) monotherapy (nivolumab) in patients with recurrent mismatch repair (MMR) deficient endometrial carcinoma with measurable or non-measurable (detectable) disease.

SECONDARY OBJECTIVES:

  1. To evaluate the overall survival (OS) as estimated from time of enrollment to last follow-up or death.

II. To evaluate the objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in those with measurable disease at start of treatment.

III. To evaluate progression-free survival at 6 months. IV. To evaluate the nature, frequency and degree of toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

  1. To evaluate PFS and objective response rate in patients with prior anti-PD1/PDL1 therapy and compare efficacy of dual immune checkpoint inhibition vs. anti-PD1 monotherapy.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle and ipilimumab IV over 90 minutes on day 1 of every other cycle. Cycles repeat every three weeks. Treatment with nivolumab and ipilimumab repeats for up to 8 cycles in the absence of disease progression, unacceptable toxicity, or complete response (CR). Patients then receive nivolumab alone on day 1 of each cycle. Cycles repeat every 4 weeks in the absence of disease progression, unacceptable toxicity, or CR.

ARM II: Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for up to 8 cycles, then every 4 weeks thereafter in the absence of disease progression, unacceptable toxicity, or CR.

MAINTENANCE THERAPY: Patients achieving CR on Arm I or II receive nivolumab for an additional 12 months in the absence of disease progression or unacceptable toxicity.

Additionally, all patients may optionally undergo collection of tissue samples on study as well as blood samples throughout the trial. All patients also undergo computed tomography (CT) scan and/or magnetic resonance imaging (MRI) throughout the trial.

Patients are followed every 3 months for 2 years, and then, every 6 months for 3 years.

Being tested
Biospecimen Collection, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging, Nivolumab
Medical subject headings
Carcinoma, Endometrioid, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of tissue and/or blood samples

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • IpilimumabBiological

    Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • NivolumabBiological

    Also called ABP 206, BCD-263, BMS 936558, BMS-936558

    Given IV

Study groups in NCT05112601
Study groupRoleWhat they receive
Arm I (nivolumab and ipilimumab)ExperimentalPatients receive nivolumab IV over 30 minutes on day 1 of each cycle and ipilimumab IV over 90 minutes on day 1 of every other cycle. Cycles repeat every three weeks. Treatment with nivolumab and ipilimumab repeats for up to 8 cycles in the absence of disease progression, unacceptable toxicity, or CR. Patients then receive nivolumab alone on day 1 of each cycle. Cycles repeat every 4 weeks in the absence of disease progression, unacceptable toxicity, or CR. MAINTENANCE THERAPY: Patients achieving CR receive nivolumab for an additional 12 months in the absence of disease progression or unacceptable toxicity. Additionally, patients may optionally undergo collection of tissue samples on study as well as blood samples throughout the trial. Patients also undergo CT scan and/or MRI throughout the trial.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Biological: Ipilimumab; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab
Arm II (nivolumab)Active comparatorPatients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for up to 8 cycles, then every 4 weeks thereafter in the absence of disease progression, unacceptable toxicity, or CR. MAINTENANCE THERAPY: Patients achieving CR receive nivolumab for an additional 12 months in the absence of disease progression or unacceptable toxicity. Additionally, patients may optionally undergo collection of tissue samples on study as well as blood samples throughout the trial. Patients also undergo CT scan and/or MRI throughout the trial.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    The statistical test used for decision making is the stratified, standardized log-rank test (Z) based on PFS. For the safety lead-in analysis, the primary endpoint is the observation of at least one dose-limiting toxicity (DLT) in the first 3 cycles of treatment. Patients are classified as having a DLT in 3 cycles or receiving adequate treatment.

    Measured: From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years after randomization

Secondary outcomes (4)

  1. Overall survival (OS)

    Will be assessed when the PFS data are mature. The null hypothesis will be that the hazard of death in regimen 1 is equal to the hazard of death in regimen 2. That is, Ho: HR = 1.00. The alternative will be that Ha: HR < 1.00 (regimen 1 to 2). The number of deaths is unknown.

    Measured: Up to 5 years after randomization

  2. Objective tumor response (ORR)

    Defined as the frequency of patients who have either a partial or complete response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The number of patients with responses will be tabulated by the treatment they were randomized to. Fisher's Exact Test will be used to test the hypothesis that the probabilities of response in each arm is the same. ORR will be evaluated only in patients who had measurable disease per RECIST 1.1 before starting treatment.

    Measured: Up to 5 years after randomization

  3. Progression-free survival (PFS) at 6 months

    A patient who survives at least 6 months progression-free will be considered to have had a successful outcome. Those who progress or die within 6 months are considered treatment failures, and those who survive progression-free for less than 6 months will be considered to have an unknown outcome or indeterminate. If the patient's status cannot be determined, she will be moved to the "failure" status for analysis. Like tumor response, the hypothesis of equivalent probabilities will be assessed with Fisher's Exact Test.

    Measured: From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed at 6 months after randomization

  4. Incidence of adverse events

    Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE). Will be tabulated by frequency and severity by treatment regimen. The treatment regimens will be compared by classifying the toxicities as severe or not and tested for equivalent probabilities by Fisher's Exact Test or whether the estimated probabilities of severe toxicities diverge by more than 10%.

    Measured: Up to 5 years after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2021
  2. Study start2 Jun 2022
  3. Primary completion30 Jul 2032 (estimated)
  4. Study completion30 Jul 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05112601
Sponsor's protocol ID
NCI-2021-11881
Other IDs
NCI-2021-11881, NRG-GY025, NRG-GY025, U10CA180868
Status last verified
Jun 2026
First submitted
6 Nov 2021
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Computed Tomography and Ipilimumab in people with Endometrial Adenocarcinoma and Endometrial Clear Cell Adenocarcinoma, run by National Cancer Institute (NCI) at 138 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 5 years after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05112601.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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