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ClinicalTrials.gov record
Completed Phase 2Phase 3 Interventional Results available

Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma

ClinicalTrials.gov ID: NCT04396860

Public ClinicalTrials.gov record NCT04396860. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 11:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients With Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase II/III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy in combination with immunotherapy with ipilimumab and nivolumab in treating patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses high energy photons to kill tumor and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Temozolomide, may not work as well for the treatment of tumors that have the unmethylated MGMT. Immunotherapy with monoclonal antibodies called immune checkpoint inhibitors, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is possible that immune checkpoint inhibitors may work better at time of first diagnosis as opposed to when tumor comes back. Giving radiation therapy with ipilimumab and nivolumab may lengthen the time without brain tumor returning or growing and may extend patients' life compared to usual treatment with radiation therapy and temozolomide.

Study identification

NCT ID
NCT04396860
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Enrollment
159 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 1, 2020 (Actual)
Primary completion
Jan 13, 2023 (Actual)
Completion
Dec 23, 2025 (Actual)
Last update posted
Apr 22, 2026

2020 – 2025

United States locations

U.S. sites
285
U.S. states
42
U.S. cities
213
Facility City State ZIP Site status
University of Alabama at Birmingham Cancer Center Birmingham Alabama 35233 —
University of Arkansas for Medical Sciences Little Rock Arkansas 72205 —
Kaiser Permanente-Anaheim Anaheim California 92806 —
Sutter Auburn Faith Hospital Auburn California 95602 —
Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California 95603 —
John Muir Medical Center-Concord Concord California 94520 —
UC San Diego Moores Cancer Center La Jolla California 92093 —
Loma Linda University Medical Center Loma Linda California 92354 —
Kaiser Permanente Los Angeles Medical Center Los Angeles California 90027 —
Cedars Sinai Medical Center Los Angeles California 90048 —
Kaiser Permanente-Ontario Ontario California 91761 —
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California 92868 —
Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California 95661 —
Sutter Roseville Medical Center Roseville California 95661 —
Sutter Medical Center Sacramento Sacramento California 95816 —
University of California Davis Comprehensive Cancer Center Sacramento California 95817 —
Torrance Memorial Physician Network - Cancer Care Torrance California 90505 —
Torrance Memorial Medical Center Torrance California 90509 —
John Muir Medical Center-Walnut Creek Walnut Creek California 94598 —
Penrose-Saint Francis Healthcare Colorado Springs Colorado 80907 —
AdventHealth Porter Denver Colorado 80210 —
AdventHealth Littleton Littleton Colorado 80122 —
AdventHealth Parker Parker Colorado 80138 —
Hartford Hospital Hartford Connecticut 06102 —
The Hospital of Central Connecticut New Britain Connecticut 06050 —
Beebe Medical Center Lewes Delaware 19958 —
Beebe South Coastal Health Campus Millville Delaware 19967 —
Delaware Clinical and Laboratory Physicians PA Newark Delaware 19713 —
Helen F Graham Cancer Center Newark Delaware 19713 —
Medical Oncology Hematology Consultants PA Newark Delaware 19713 —
Christiana Care Health System-Christiana Hospital Newark Delaware 19718 —
Beebe Health Campus Rehoboth Beach Delaware 19971 —
Baptist MD Anderson Cancer Center Jacksonville Florida 32207 —
AdventHealth Orlando Orlando Florida 32803 —
Augusta University Medical Center Augusta Georgia 30912 —
Memorial Health University Medical Center Savannah Georgia 31404 —
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia 31405 —
Lewis Hall Singletary Oncology Center Thomasville Georgia 31792 —
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii 96813 —
Island Urology Honolulu Hawaii 96813 —
Queen's Cancer Cenrer - POB I Honolulu Hawaii 96813 —
Queen's Medical Center Honolulu Hawaii 96813 —
Straub Clinic and Hospital Honolulu Hawaii 96813 —
University of Hawaii Cancer Center Honolulu Hawaii 96813 —
Hawaii Cancer Care Inc-Liliha Honolulu Hawaii 96817 —
Queen's Cancer Center - Kuakini Honolulu Hawaii 96817 —
The Cancer Center of Hawaii-Liliha Honolulu Hawaii 96817 —
Kapiolani Medical Center for Women and Children Honolulu Hawaii 96826 —
Castle Medical Center Kailua Hawaii 96734 —
Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii 96766 —
Hawaii Cancer Care - Westridge ‘Aiea Hawaii 96701 —
Pali Momi Medical Center ‘Aiea Hawaii 96701 —
Queen's Cancer Center - Pearlridge ‘Aiea Hawaii 96701 —
The Cancer Center of Hawaii-Pali Momi ‘Aiea Hawaii 96701 —
Saint Luke's Cancer Institute - Boise Boise Idaho 83712 —
Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho 83605 —
Saint Luke's Cancer Institute - Fruitland Fruitland Idaho 83619 —
Saint Luke's Cancer Institute - Meridian Meridian Idaho 83642 —
Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho 83687 —
Saint Luke's Cancer Institute - Nampa Nampa Idaho 83687 —
Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho 83301 —
Illinois CancerCare-Bloomington Bloomington Illinois 61704 —
Illinois CancerCare-Canton Canton Illinois 61520 —
Illinois CancerCare-Carthage Carthage Illinois 62321 —
Centralia Oncology Clinic Centralia Illinois 62801 —
Northwestern University Chicago Illinois 60611 —
University of Illinois Chicago Illinois 60612 —
Carle at The Riverfront Danville Illinois 61832 —
Cancer Care Specialists of Illinois - Decatur Decatur Illinois 62526 —
Decatur Memorial Hospital Decatur Illinois 62526 —
Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois 60115 —
Carle Physician Group-Effingham Effingham Illinois 62401 —
Crossroads Cancer Center Effingham Illinois 62401 —
Elmhurst Memorial Hospital Elmhurst Illinois 60126 —
Illinois CancerCare-Eureka Eureka Illinois 61530 —
NorthShore University HealthSystem-Evanston Hospital Evanston Illinois 60201 —
Illinois CancerCare-Galesburg Galesburg Illinois 61401 —
Western Illinois Cancer Treatment Center Galesburg Illinois 61401 —
Northwestern Medicine Cancer Center Delnor Geneva Illinois 60134 —
NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois 60026 —
NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois 60035 —
Illinois CancerCare-Kewanee Clinic Kewanee Illinois 61443 —
Illinois CancerCare-Macomb Macomb Illinois 61455 —
Carle Physician Group-Mattoon/Charleston Mattoon Illinois 61938 —
Edward Hospital/Cancer Center Naperville Illinois 60540 —
Cancer Care Center of O'Fallon O'Fallon Illinois 62269 —
Illinois CancerCare-Ottawa Clinic Ottawa Illinois 61350 —
Advocate Lutheran General Hospital Park Ridge Illinois 60068 —
Illinois CancerCare-Pekin Pekin Illinois 61554 —
Illinois CancerCare-Peoria Peoria Illinois 61615 —
Methodist Medical Center of Illinois Peoria Illinois 61636 —
OSF Saint Francis Medical Center Peoria Illinois 61637 —
Illinois CancerCare-Peru Peru Illinois 61354 —
Illinois CancerCare-Princeton Princeton Illinois 61356 —
UW Health Carbone Cancer Center Rockford Rockford Illinois 61114 —
Southern Illinois University School of Medicine Springfield Illinois 62702 —
Springfield Clinic Springfield Illinois 62702 —
Springfield Memorial Hospital Springfield Illinois 62781 —
Carle Cancer Center Urbana Illinois 61801 —
The Carle Foundation Hospital Urbana Illinois 61801 —
Northwestern Medicine Cancer Center Warrenville Warrenville Illinois 60555 —
Illinois CancerCare - Washington Washington Illinois 61571 —
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana 46202 —
IU Health Methodist Hospital Indianapolis Indiana 46202 —
Mary Greeley Medical Center Ames Iowa 50010 —
McFarland Clinic - Ames Ames Iowa 50010 —
Mercy Cancer Center-West Lakes Clive Iowa 50325 —
UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive Iowa 50325 —
Heartland Oncology and Hematology LLP Council Bluffs Iowa 51503 —
Methodist Jennie Edmundson Hospital Council Bluffs Iowa 51503 —
Greater Regional Medical Center Creston Iowa 50801 —
Iowa Methodist Medical Center Des Moines Iowa 50309 —
UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines Iowa 50309 —
Broadlawns Medical Center Des Moines Iowa 50314 —
Mercy Medical Center - Des Moines Des Moines Iowa 50314 —
UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines Iowa 50314 —
University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa 52242 —
Mercy Medical Center-West Lakes West Des Moines Iowa 50266 —
University of Kentucky/Markey Cancer Center Lexington Kentucky 40536 —
Tulane University School of Medicine New Orleans Louisiana 70112 —
Ochsner Medical Center Jefferson New Orleans Louisiana 70121 —
Eastern Maine Medical Center Bangor Maine 04401 —
MaineHealth Coastal Cancer Treatment Center Bath Maine 04530 —
MaineHealth Waldo Hospital Belfast Maine 04915 —
Lafayette Family Cancer Center-EMMC Brewer Maine 04412 —
MaineHealth Maine Medical Center - Portland Portland Maine 04102 —
Penobscot Bay Medical Center Rockport Maine 04856 —
MaineHealth Cancer Care Center of York County Sanford Maine 04073 —
Maine Medical Partners Neurology Scarborough Maine 04074 —
MaineHealth Maine Medical Center- Scarborough Scarborough Maine 04074 —
MaineHealth Cancer Care and IV Therapy - South Portland South Portland Maine 04106 —
University of Maryland/Greenebaum Cancer Center Baltimore Maryland 21201 —
UM Upper Chesapeake Medical Center Bel Air Maryland 21014 —
Central Maryland Radiation Oncology in Howard County Columbia Maryland 21044 —
UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland 21061 —
Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan 48106 —
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan 48114 —
Trinity Health Medical Center - Brighton Brighton Michigan 48114 —
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan 48188 —
Trinity Health Medical Center - Canton Canton Michigan 48188 —
Chelsea Hospital Chelsea Michigan 48118 —
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan 48118 —
Corewell Health Dearborn Hospital Dearborn Michigan 48124 —
Henry Ford Health Saint John Hospital Detroit Michigan 48236 —
Genesys Hurley Cancer Institute Flint Michigan 48503 —
Hurley Medical Center Flint Michigan 48503 —
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan 49503 —
Bronson Methodist Hospital Kalamazoo Michigan 49007 —
West Michigan Cancer Center Kalamazoo Michigan 49007 —
Beacon Kalamazoo Kalamazoo Michigan 49048 —
Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan 48154 —
Michigan Healthcare Professionals Pontiac Pontiac Michigan 48341 —
Corewell Health William Beaumont University Hospital Royal Oak Michigan 48073 —
MyMichigan Medical Center Saginaw Saginaw Michigan 48601 —
Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan 48604 —
MyMichigan Medical Center Tawas Tawas City Michigan 48764 —
Corewell Health Beaumont Troy Hospital Troy Michigan 48085 —
Henry Ford Health Warren Hospital Warren Michigan 48093 —
Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan 48661 —
University of Michigan Health - West Wyoming Michigan 49519 —
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan 48197 —
Sanford Joe Lueken Cancer Center Bemidji Minnesota 56601 —
Fairview Ridges Hospital Burnsville Minnesota 55337 —
Minnesota Oncology - Burnsville Burnsville Minnesota 55337 —
Mercy Hospital Coon Rapids Minnesota 55433 —
Fairview Southdale Hospital Edina Minnesota 55435 —
Unity Hospital Fridley Minnesota 55432 —
Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota 55369 —
Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota 55109 —
Hennepin County Medical Center Minneapolis Minnesota 55415 —
Health Partners Inc Minneapolis Minnesota 55454 —
Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota 55416 —
Regions Hospital Saint Paul Minnesota 55101 —
United Hospital Saint Paul Minnesota 55102 —
Lakeview Hospital Stillwater Minnesota 55082 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi 38671 —
Saint Francis Medical Center Cape Girardeau Missouri 63703 —
Billings Clinic Cancer Center Billings Montana 59101 —
Bozeman Health Deaconess Hospital Bozeman Montana 59715 —
Saint James Community Hospital and Cancer Treatment Center Butte Montana 59701 —
Benefis Sletten Cancer Institute Great Falls Montana 59405 —
Logan Health Medical Center Kalispell Montana 59901 —
Nebraska Medicine-Bellevue Bellevue Nebraska 68123 —
Cancer Partners of Nebraska Lincoln Nebraska 68516 —
Nebraska Methodist Hospital Omaha Nebraska 68114 —
Nebraska Medicine-Village Pointe Omaha Nebraska 68118 —
University of Nebraska Medical Center Omaha Nebraska 68198 —
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire 03756 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Saint Barnabas Medical Center Livingston New Jersey 07039 —
Morristown Medical Center Morristown New Jersey 07960 —
Jersey Shore Medical Center Neptune City New Jersey 07753 —
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey 08903 —
Capital Health Medical Center-Hopewell Pennington New Jersey 08534 —
Overlook Hospital Summit New Jersey 07902 —
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York 10016 —
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York 10032 —
NYP/Weill Cornell Medical Center New York New York 10065 —
University of Rochester Rochester New York 14642 —
State University of New York Upstate Medical University Syracuse New York 13210 —
Good Samaritan University Hospital West Islip New York 11795 —
Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina 28203 —
Atrium Health Pineville/LCI-Pineville Charlotte North Carolina 28210 —
Atrium Health Cabarrus/LCI-Concord Concord North Carolina 28025 —
Sanford Bismarck Medical Center Bismarck North Dakota 58501 —
Sanford Broadway Medical Center Fargo North Dakota 58122 —
Sanford Roger Maris Cancer Center Fargo North Dakota 58122 —
Summa Health System - Akron Campus Akron Ohio 44304 —
Case Western Reserve University Cleveland Ohio 44106 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Riverside Methodist Hospital Columbus Ohio 43214 —
Dublin Methodist Hospital Dublin Ohio 43016 —
Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma 73505 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Clackamas Radiation Oncology Center Clackamas Oregon 97015 —
Providence Cancer Institute Clackamas Clinic Clackamas Oregon 97015 —
Legacy Mount Hood Medical Center Gresham Oregon 97030 —
Providence Newberg Medical Center Newberg Oregon 97132 —
Legacy Good Samaritan Hospital and Medical Center Portland Oregon 97210 —
Providence Portland Medical Center Portland Oregon 97213 —
Providence Saint Vincent Medical Center Portland Oregon 97225 —
Kaiser Permanente Northwest Portland Oregon 97227 —
Legacy Meridian Park Hospital Tualatin Oregon 97062 —
Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania 18103 —
Crozer-Keystone Regional Cancer Center at Broomall Broomall Pennsylvania 19008 —
Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania 19317 —
Lancaster General Ann B Barshinger Cancer Institute Lancaster Pennsylvania 17601 —
Lancaster General Hospital Lancaster Pennsylvania 17602 —
Forbes Hospital Monroeville Pennsylvania 15146 —
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107 —
Allegheny General Hospital Pittsburgh Pennsylvania 15212 —
University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania 15232 —
UPMC-Shadyside Hospital Pittsburgh Pennsylvania 15232 —
Reading Hospital West Reading Pennsylvania 19611 —
Wexford Health and Wellness Pavilion Wexford Pennsylvania 15090 —
Rock Hill Radiation Therapy Center Rock Hill South Carolina 29730 —
Avera Cancer Institute at Pierre Pierre South Dakota 57501 —
Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota 57104 —
Avera Cancer Institute Sioux Falls South Dakota 57105 —
Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota 57117-5134 —
Baptist Memorial Hospital and Cancer Center-Collierville Collierville Tennessee 38017 —
Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee 38120 —
Memorial Hermann Texas Medical Center Houston Texas 77030 —
University of Texas Health Science Center at San Antonio San Antonio Texas 78229 —
American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah 84003 —
Sandra L Maxwell Cancer Center Cedar City Utah 84720 —
Logan Regional Hospital Logan Utah 84321 —
Intermountain Medical Center Murray Utah 84107 —
McKay-Dee Hospital Center Ogden Utah 84403 —
Utah Valley Regional Medical Center Provo Utah 84604 —
Riverton Hospital Riverton Utah 84065 —
Huntsman Cancer Institute/University of Utah Salt Lake City Utah 84112 —
LDS Hospital Salt Lake City Utah 84143 —
Saint George Regional Medical Center St. George Utah 84770 —
Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners Vermont 05602 —
University of Vermont Medical Center Burlington Vermont 05401 —
University of Vermont and State Agricultural College Burlington Vermont 05405 —
Inova Schar Cancer Institute Fairfax Virginia 22031 —
VCU Massey Comprehensive Cancer Center Richmond Virginia 23298 —
VCU Community Memorial Health Center South Hill Virginia 23970 —
Virginia Mason Medical Center Seattle Washington 98101 —
Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver Washington 98684 —
Legacy Salmon Creek Hospital Vancouver Washington 98686 —
Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia 26003 —
Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin 53105 —
Aurora Health Care Germantown Health Center Germantown Wisconsin 53022 —
Aurora Cancer Care-Grafton Grafton Wisconsin 53024 —
Aurora BayCare Medical Center Green Bay Wisconsin 54311 —
University of Wisconsin Carbone Cancer Center - Johnson Creek Johnson Creek Wisconsin 53038 —
Aurora Cancer Care-Kenosha South Kenosha Wisconsin 53142 —
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin 53792 —
Aurora Bay Area Medical Group-Marinette Marinette Wisconsin 54143 —
Aurora Cancer Care-Milwaukee Milwaukee Wisconsin 53209 —
Aurora Saint Luke's Medical Center Milwaukee Wisconsin 53215 —
Aurora Sinai Medical Center Milwaukee Wisconsin 53233 —
Marshfield Medical Center - Minocqua Minocqua Wisconsin 54548 —
Cancer Center of Western Wisconsin New Richmond Wisconsin 54017 —
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin 54904 —
Aurora Cancer Care-Racine Racine Wisconsin 53406 —
Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin 53081 —
Aurora Medical Center in Summit Summit Wisconsin 53066 —
Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin 54241 —
Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin 53226 —
Aurora West Allis Medical Center West Allis Wisconsin 53227 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04396860, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 22, 2026 · Synced Oct 21, 2026

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Open the official record

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