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Treating Recurrent dMMR or MSI-High Endometrial Cancer with the Immunotherapy Drug, Nivolumab with or without the Immunotherapy Drug, Ipilimumab

Treatment

Phase 2 treatment study for recurrent endometrial cancer with dMMR or MSI-High biomarker

Clinicaltrials.gov identifier:
NCT05112601

Study Contact Information:

Please reach out to the individual contact at the study site you wish to enroll in. See the locations section below. 

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Overview
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Details
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About The Study

This clinical trial is studying two different approaches for people with endometrial cancer that has come back after treatment (recurrent). It focuses on tumors that have a called , ( or ) or microsite instability high (). These biomarkers are often found in cancers that respond to .

Researchers want to see whether giving the nivolumab (Opdivo) together with a second called ipilimumab (Yervoy) works better to shrink tumors and delay the cancer’s return than giving nivolumab by itself. Both nivolumab and ipilimumab are drugs that help the immune system recognize and attack cancer cells.

This Study is Open To:

People with the following may be eligible:

  • diagnosed with recurrent endometrial cancer whose tumors have a  called deficient mismatch repair ( or ).
  • participants may have received previous treatments, including:
    • one or two prior chemotherapy treatments.
    • prior (anti-PD-1 or anti-PD-L1) that was given in combination with chemotherapy or radiation, the cancer initially responded fully, and it returned at least 12 months after the last dose. 
    • prior radiation therapy for endometrial cancer, as long as radiation ended at least 4 weeks before joining the study.  
    • prior hormonal therapy for endometrial cancer, as long as the hormonal treatment was stopped at least 3 weeks before joining the study. 

This Study is NOT Open To:

People cannot join the study if they: 

  • do not have recurrent endometrial cancer.
  • have a subtype of endometrial cancer called serous carcinoma or carcinosarcoma.
  • their cancer is mismatch repair proficient (pMMR or MMR-P) and microsatellite stable (MSS). 
  • have received previous treatment with a type of known as a CTLA-4 inhibitor. 

What the Study Involves

If a person joins this study, they will be randomly placed into one of two groups:

  • Group 1: Receive nivolumab combined with ipilimumab.

  • Group 2: Receive nivolumab alone.

Treatment is given through intravenous (IV) infusions at scheduled intervals. Some participants may also have tissue and blood samples collected, as well as imaging studies like CT or , to monitor the cancer.

Participants will continue treatment until the cancer progresses, side effects become unacceptable, or they complete the planned treatment. After treatment, participants are followed regularly to check their health and monitor cancer outcomes.

Study Contact Information:

Please reach out to the individual contact at the study site you wish to enroll in. See the locations section below. 

Locations:

Alabama

City: Birmingham RECRUITING
Facility: University of Alabama at Birmingham Cancer Center
Contact Info:
charlesbaldwin@uabmc.edu 205-895-1816
Michael D. Toboni

Georgia

City: Athens RECRUITING
Facility: University Cancer and Blood Center LLC
Contact Info:
research@universitycancer.com
Sharad A. Ghamande

City: Augusta RECRUITING
Facility: Augusta University Medical Center
Contact Info:
ga_cares@augusta.edu 706-721-2388
Sharad A. Ghamande

Iowa

City: Iowa City RECRUITING
Facility: University of Iowa/Holden Comprehensive Cancer Center
Contact Info:
800-237-1225
David P. Bender

Idaho

City: Boise RECRUITING
Facility: Saint Luke's Cancer Institute - Boise
Contact Info:
eslinget@slhs.org 208-381-2774
Dan S. Zuckerman

City: Coeur d'Alene RECRUITING
Facility: Kootenai Health - Coeur d'Alene
Contact Info:
mccinfo@mtcancer.org 406-969-6060
John M. Schallenkamp

City: Fruitland RECRUITING
Facility: Saint Luke's Cancer Institute - Fruitland
Contact Info:
eslinget@slhs.org 208-381-2774
Dan S. Zuckerman

City: Meridian RECRUITING
Facility: Saint Luke's Cancer Institute - Meridian
Contact Info:
eslinget@slhs.org 208-381-2774
Dan S. Zuckerman

City: Nampa RECRUITING
Facility: Saint Luke's Cancer Institute - Nampa
Contact Info:
eslinget@slhs.org 208-381-2774
Dan S. Zuckerman

City: Post Falls RECRUITING
Facility: Kootenai Clinic Cancer Services - Post Falls
Contact Info:
mccinfo@mtcancer.org 406-969-6060
John M. Schallenkamp

City: Sandpoint RECRUITING
Facility: Kootenai Clinic Cancer Services - Sandpoint
Contact Info:
mccinfo@mtcancer.org 406-969-6060
John M. Schallenkamp

Illinois

City: Chicago RECRUITING
Facility: University of Illinois
Contact Info:
312-355-3046
Sarah Werner

City: Danville RECRUITING
Facility: Carle at The Riverfront
Contact Info:
Research@Carle.com 800-446-5532
Pratima Chalasani

City: Effingham RECRUITING
Facility: Carle Physician Group-Effingham
Contact Info:
Research@carle.com 800-446-5532
Pratima Chalasani

City: Mattoon RECRUITING
Facility: Carle Physician Group-Mattoon/Charleston
Contact Info:
Research@carle.com 800-446-5532
Pratima Chalasani

City: Normal RECRUITING
Facility: Carle Cancer Institute Normal
Contact Info:
Research@Carle.com 800-446-5532
Pratima Chalasani

City: Normal RECRUITING
Facility: Carle BroMenn Medical Center
Contact Info:
Research@Carle.com 800-446-5532
Pratima Chalasani

City: Urbana RECRUITING
Facility: Carle Cancer Center
Contact Info:
Research@carle.com 800-446-5532
Pratima Chalasani

Indiana

City: Carmel RECRUITING
Facility: IU Health North Hospital
Contact Info:
iutrials@iu.edu 317-278-5632
Lisa M. Landrum

City: Crown Point RECRUITING
Facility: Northwest Cancer Center - Main Campus
Contact Info:
219-310-2550
Pratima Chalasani

City: Dyer RECRUITING
Facility: Northwest Oncology LLC
Contact Info:
219-924-8178
Pratima Chalasani

City: Hobart RECRUITING
Facility: Northwest Cancer Center - Hobart
Contact Info:
219-947-1795
Pratima Chalasani

City: Hobart RECRUITING
Facility: Saint Mary Medical Center
Contact Info:
CancerResearch@COMHS.org 219-836-6875
Pratima Chalasani

City: Indianapolis RECRUITING
Facility: Indiana University/Melvin and Bren Simon Cancer Center
Contact Info:
iutrials@iu.edu 317-278-5632
Lisa M. Landrum

City: Indianapolis RECRUITING
Facility: Saint Catherine Hospital
Contact Info:
Roster@nrgoncology.org 412-339-5294
Pratima Chalasani

City: Munster RECRUITING
Facility: The Community Hospital
Contact Info:
219-836-3349
Pratima Chalasani

City: Munster RECRUITING
Facility: Women's Diagnostic Center - Munster
Contact Info:
mnicholson@comhs.org 219-934-8869
Pratima Chalasani

City: Valparaiso RECRUITING
Facility: Northwest Cancer Center - Valparaiso
Contact Info:
CancerResearch@COMHS.org 219-836-6875
Pratima Chalasani

Kentucky

City: Louisville RECRUITING
Facility: The James Graham Brown Cancer Center at University of Louisville
Contact Info:
502-562-3429
Jason A. Chesney

City: Louisville RECRUITING
Facility: UofL Health Medical Center Northeast
Contact Info:
ctoinfo@louisville.edu 502-852-2755
Jason A. Chesney

Minnesota

City: Coon Rapids RECRUITING
Facility: Mercy Hospital
Contact Info:
mmcorc@healthpartners.com 952-993-1517
Adrianne Mallen

City: Deer River RECRUITING
Facility: Essentia Health - Deer River Clinic
Contact Info:
CancerTrials@EssentiaHealth.org 218-786-3308
Bret E. Friday

City: Duluth RECRUITING
Facility: Essentia Health Cancer Center
Contact Info:
CancerTrials@EssentiaHealth.org 218-786-3308
Bret E. Friday

City: Duluth RECRUITING
Facility: Miller-Dwan Hospital
Contact Info:
CancerTrials@EssentiaHealth.org 218-786-3308
Bret E. Friday

City: Edina RECRUITING
Facility: Fairview Southdale Hospital
Contact Info:
mmcorc@healthpartners.com 952-993-1517
Adrianne Mallen

City: Hibbing RECRUITING
Facility: Essentia Health Hibbing Clinic
Contact Info:
218-786-3308
Bret E. Friday

City: Minneapolis RECRUITING
Facility: Abbott-Northwestern Hospital
Contact Info:
mmcorc@healthpartners.com 952-993-1517
Adrianne Mallen

City: Saint Louis Park RECRUITING
Facility: Park Nicollet Clinic - Saint Louis Park
Contact Info:
mmcorc@healthpartners.com 952-993-1517
Adrianne Mallen

City: Saint Paul RECRUITING
Facility: Regions Hospital
Contact Info:
mmcorc@healthpartners.com 952-993-1517
Adrianne Mallen

City: Saint Paul RECRUITING
Facility: United Hospital
Contact Info:
mmcorc@healthpartners.com 952-993-1517
Adrianne Mallen

City: Sandstone RECRUITING
Facility: Essentia Health Sandstone
Contact Info:
CancerTrials@EssentiaHealth.org 218-786-3308
Bret E. Friday

City: Shakopee RECRUITING
Facility: Saint Francis Regional Medical Center
Contact Info:
mmcorc@healthpartners.com 952-993-1517
Adrianne Mallen

City: Virginia RECRUITING
Facility: Essentia Health Virginia Clinic
Contact Info:
CancerTrials@EssentiaHealth.org 218-786-3308
Bret E. Friday

Missouri

City: St Louis RECRUITING
Facility: Washington University School of Medicine
Contact Info:
info@siteman.wustl.edu 800-600-3606
Premal H. Thaker

Montana

City: Anaconda RECRUITING
Facility: Community Hospital of Anaconda
Contact Info:
mccinfo@mtcancer.org 406-969-6060
John M. Schallenkamp

City: Billings RECRUITING
Facility: Billings Clinic Cancer Center
Contact Info:
research@billingsclinic.org 800-996-2663
John M. Schallenkamp

City: Billings RECRUITING
Facility: Saint Vincent Frontier Cancer Center
Contact Info:
800-648-6274
Megan Petersen

City: Billings RECRUITING
Facility: Intermountain Health West End Clinic
Contact Info:
406-238-6685
Megan Petersen

City: Bozeman RECRUITING
Facility: Bozeman Health Deaconess Hospital
Contact Info:
mccinfo@mtcancer.org 406-969-6060
John M. Schallenkamp

City: Great Falls RECRUITING
Facility: Benefis Sletten Cancer Institute
Contact Info:
mccinfo@mtcancer.org 406-969-6060
John M. Schallenkamp

City: Kalispell RECRUITING
Facility: Logan Health Medical Center
Contact Info:
mccinfo@mtcancer.org 406-969-6060
John M. Schallenkamp

City: Missoula RECRUITING
Facility: Community Medical Center
Contact Info:
mccinfo@mtcancer.org 406-969-6060
John M. Schallenkamp

North Carolina

City: Durham RECRUITING
Facility: Duke University Medical Center
Contact Info:
888-275-3853
Angeles A. Secord

City: Raleigh RECRUITING
Facility: Duke Women's Cancer Care Raleigh
Contact Info:
919-785-4878
Angeles A. Secord

North Dakota

City: Fargo RECRUITING
Facility: Essentia Health Cancer Center-South University Clinic
Contact Info:
CancerTrials@EssentiaHealth.org 218-786-3308
Bret E. Friday

Nebraska

City: Omaha RECRUITING
Facility: Nebraska Methodist Hospital
Contact Info:
402-354-5144
Brent J. Tierney

New Mexico

City: Albuquerque RECRUITING
Facility: University of New Mexico Cancer Center
Contact Info:
HSC-ClinicalTrialInfo@salud.unm.edu 505-925-0348
Carolyn Y. Muller

Nevada

City: Las Vegas RECRUITING
Facility: Women's Cancer Center of Nevada
Contact Info:
702-851-4672
Nicola M. Spirtos

New York

City: Rochester RECRUITING
Facility: University of Rochester
Contact Info:
585-275-5830
Rachael Turner

City: Syracuse RECRUITING
Facility: State University of New York Upstate Medical University
Contact Info:
315-464-5476
Mary J. Cunningham

City: Webster RECRUITING
Facility: Wilmot Cancer Institute at Webster
Contact Info:
WCICTOresearch@urmc.rochester.edu
Rachael Turner

Ohio

City: Beachwood RECRUITING
Facility: UHHS-Chagrin Highlands Medical Center
Contact Info:
CTUReferral@UHhospitals.org 800-641-2422
Amy Armstrong

City: Centerville RECRUITING
Facility: Miami Valley Hospital South
Contact Info:
clinical.trials@daytonncorp.org 937-528-2900
Michael S. Guy

City: Chardon RECRUITING
Facility: Geauga Hospital
Contact Info:
CTUReferral@UHhospitals.org 800-641-2422
Amy Armstrong

City: Cincinnati RECRUITING
Facility: Good Samaritan Hospital - Cincinnati
Contact Info:
ResearchInstituteInquiries@CommonSpirit.org 720-874-1881
Shahzad Siddique

City: Cleveland RECRUITING
Facility: Case Western Reserve University
Contact Info:
CTUReferral@UHhospitals.org 800-641-2422
Amy Armstrong

City: Cleveland RECRUITING
Facility: Cleveland Clinic Cancer Center/Fairview Hospital
Contact Info:
TaussigResearch@ccf.org 866-223-8100
Peter G. Rose

City: Cleveland RECRUITING
Facility: Cleveland Clinic Foundation
Contact Info:
TaussigResearch@ccf.org 866-223-8100
Peter G. Rose

City: Columbus RECRUITING
Facility: Ohio State University Comprehensive Cancer Center
Contact Info:
Jamesline@osumc.edu 800-293-5066
Floor Backes

City: Mayfield Heights RECRUITING
Facility: Hillcrest Hospital Cancer Center
Contact Info:
TaussigResearch@ccf.org 866-223-8100
Peter G. Rose

City: Mentor RECRUITING
Facility: UH Seidman Cancer Center at Lake Health Mentor Campus
Contact Info:
CTUReferral@UHhospitals.org 800-641-2422
Amy Armstrong

City: Westlake RECRUITING
Facility: UH Seidman Cancer Center at Saint John Medical Center
Contact Info:
CTUReferral@UHhospitals.org 800-641-2422
Amy Armstrong

Oklahoma

City: Oklahoma City RECRUITING
Facility: University of Oklahoma Health Sciences Center
Contact Info:
ou-clinical-trials@ouhsc.edu 405-271-8777
Christina Washington

City: Tulsa RECRUITING
Facility: Oklahoma Cancer Specialists and Research Institute-Tulsa
Contact Info:
918-505-3200
Katherine M. Moxley

Oregon

City: Portland RECRUITING
Facility: Providence Portland Medical Center
Contact Info:
CanRsrchStudies@providence.org 503-215-2614
Dan S. Zuckerman

City: Portland RECRUITING
Facility: Providence Saint Vincent Medical Center
Contact Info:
CanRsrchStudies@providence.org 503-215-2614
Dan S. Zuckerman

Pennsylvania

City: Beaver RECRUITING
Facility: UPMC-Heritage Valley Health System Beaver
Contact Info:
haneydl@upmc.edu 412-389-5208
Alexander B. Olawaiye

City: Butler RECRUITING
Facility: UPMC Hillman Cancer Center at Butler Health System
Contact Info:
haneydl@upmc.edu 412-389-5208
Alexander B. Olawaiye

City: Cranberry Township RECRUITING
Facility: UPMC Hillman Cancer Center - Passavant - Cranberry
Contact Info:
haneydl@upmc.edu 412-389-5208
Alexander B. Olawaiye

City: Erie RECRUITING
Facility: UPMC Hillman Cancer Center Erie
Contact Info:
ClinicalResearchServices@upmc.edu 412-864-7716
Alexander B. Olawaiye

City: Farrell RECRUITING
Facility: UPMC Cancer Center at UPMC Horizon
Contact Info:
Roster@nrgoncology.org 412-339-5294
Alexander B. Olawaiye

City: Greensburg RECRUITING
Facility: UPMC Cancer Centers - Arnold Palmer Pavilion
Contact Info:
724-838-1900
Alexander B. Olawaiye

City: Indiana RECRUITING
Facility: IRMC Cancer Center
Contact Info:
haneydl@upmc.edu 412-389-5208
Alexander B. Olawaiye

City: Johnstown RECRUITING
Facility: UPMC-Johnstown/John P. Murtha Regional Cancer Center
Contact Info:
814-534-4724
Alexander B. Olawaiye

City: McKeesport RECRUITING
Facility: UPMC Cancer Center at UPMC McKeesport
Contact Info:
412-647-8073
Alexander B. Olawaiye

City: Mechanicsburg RECRUITING
Facility: UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Contact Info:
haneydl@upmc.edu 412-389-5208
Alexander B. Olawaiye

City: Monroeville RECRUITING
Facility: UPMC Hillman Cancer Center - Monroeville
Contact Info:
ClinicalResearchServices@upmc.edu 412-864-7716
Alexander B. Olawaiye

City: Moon Township RECRUITING
Facility: UPMC Hillman Cancer Center in Coraopolis
Contact Info:
haneydl@upmc.edu 412-389-5208
Alexander B. Olawaiye

City: Mount Pleasant RECRUITING
Facility: UPMC Hillman Cancer Center - Part of Frick Hospital
Contact Info:
haneydl@upmc.edu 412-389-5208
Alexander B. Olawaiye

City: N. Huntingdon RECRUITING
Facility: Arnold Palmer Cancer Center Medical Oncology Norwin
Contact Info:
ClinicalResearchServices@upmc.edu 412-864-7716
Alexander B. Olawaiye

City: Natrona Heights RECRUITING
Facility: UPMC Cancer Center-Natrona Heights
Contact Info:
724-230-3030
Alexander B. Olawaiye

City: New Castle RECRUITING
Facility: UPMC Hillman Cancer Center - New Castle
Contact Info:
haneydl@upmc.edu 412-389-5208
Alexander B. Olawaiye

City: Pittsburgh RECRUITING
Facility: UPMC-Magee Womens Hospital
Contact Info:
412-647-2811
Alexander B. Olawaiye

City: Pittsburgh RECRUITING
Facility: UPMC-Saint Margaret
Contact Info:
412-784-4900
Alexander B. Olawaiye

City: Pittsburgh RECRUITING
Facility: UPMC-Mercy Hospital
Contact Info:
800-533-8762
Alexander B. Olawaiye

City: Pittsburgh RECRUITING
Facility: University of Pittsburgh Cancer Institute (UPCI)
Contact Info:
412-647-8073
Alexander B. Olawaiye

City: Pittsburgh RECRUITING
Facility: UPMC-Passavant Hospital
Contact Info:
412-367-6454
Alexander B. Olawaiye

City: Pittsburgh RECRUITING
Facility: UPMC-Saint Clair Hospital Cancer Center
Contact Info:
412-502-3920
Alexander B. Olawaiye

City: Seneca RECRUITING
Facility: UPMC Cancer Center at UPMC Northwest
Contact Info:
814-676-7900
Alexander B. Olawaiye

City: Washington RECRUITING
Facility: UPMC Cancer Center-Washington
Contact Info:
Roster@nrgoncology.org 412-339-5294
Alexander B. Olawaiye

City: West Mifflin RECRUITING
Facility: UPMC West Mifflin-Cancer Center Jefferson
Contact Info:
412-653-8100
Alexander B. Olawaiye

Rhode Island

City: Providence RECRUITING
Facility: Women and Infants Hospital
Contact Info:
401-274-1122
Cara A. Mathews

Texas

City: Dallas RECRUITING
Facility: Parkland Memorial Hospital
Contact Info:
canceranswerline@UTSouthwestern.edu 214-590-5582
David S. Miller

City: Dallas RECRUITING
Facility: UT Southwestern/Simmons Cancer Center-Dallas
Contact Info:
canceranswerline@UTSouthwestern.edu 214-648-7097
David S. Miller

City: Fort Worth RECRUITING
Facility: UT Southwestern/Simmons Cancer Center-Fort Worth
Contact Info:
canceranswerline@UTSouthwestern.edu 214-648-7097
David S. Miller

City: Richardson RECRUITING
Facility: UT Southwestern Clinical Center at Richardson/Plano
Contact Info:
Suzanne.cole@utsouthwestern.edu 972-669-7044
David S. Miller

Virginia

City: Charlottesville RECRUITING
Facility: University of Virginia Cancer Center
Contact Info:
uvacancertrials@hscmail.mcc.virginia.edu 434-243-6303
Linda R. Duska

City: Richmond RECRUITING
Facility: Henrico Doctor's Hospital
Contact Info:
804-591-4152
Andrew S. Kennedy

City: Richmond RECRUITING
Facility: VCU Massey Comprehensive Cancer Center
Contact Info:
CTOclinops@vcu.edu 804-628-6430
Chelsea Salyer

Washington

City: Edmonds RECRUITING
Facility: Swedish Cancer Institute-Edmonds
Contact Info:
PCRC-NCORP@Swedish.org 206-215-2343
Dan S. Zuckerman

City: Issaquah RECRUITING
Facility: Swedish Cancer Institute-Issaquah
Contact Info:
PCRC-NCORP@Swedish.org 206-215-2343
Dan S. Zuckerman

City: Seattle RECRUITING
Facility: Swedish Medical Center-First Hill
Contact Info:
PCRC-NCORP@Swedish.org 206-215-2343
Dan S. Zuckerman

Wisconsin

City: Ashland RECRUITING
Facility: Duluth Clinic Ashland
Contact Info:
CancerTrials@EssentiaHealth.org 218-786-3308
Bret E. Friday

City: Ashland RECRUITING
Facility: Northwest Wisconsin Cancer Center
Contact Info:
CancerTrials@EssentiaHealth.org 218-786-3308
Bret E. Friday

Treatment

Phase 2 treatment study for recurrent endometrial cancer with dMMR or MSI-High biomarker

Clinicaltrials.gov identifier:
NCT05112601

Study Contact Information:

Please reach out to the individual contact at the study site you wish to enroll in. See the locations section below. 

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