Testen van nivolumab en ipilimumab met kortdurende straling bij lokaal gevorderde endeldarmkanker
21 oktober 2026 bijgewerkt door: National Cancer Institute (NCI)
Een fase II-studie van neoadjuvant nivolumab plus ipilimumab en kortdurende bestraling bij MSI-H/dMMR lokaal gevorderd rectaal adenocarcinoom
This phase II trial investigates the effect of nivolumab and ipilimumab when given together with short-course radiation therapy in treating patients with rectal cancer that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may kill more cancer cells.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Gedetailleerde beschrijving
PRIMARY OBJECTIVE:
I. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve the pathologic complete response rate (pCR) in microsatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR) locally advanced rectal adenocarcinoma at total mesorectal excision (TME).
SECONDARY OBJECTIVES:
I. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve the rate of sphincter preservation in low-lying tumors.
II. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve 5-year disease-free survival (DFS).
III. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve overall survival (OS).
IV. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will have acceptable safety/toxicity.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for 2 cycles. Starting at least 2 weeks but no longer than 6 weeks after completion of cycle 2 of nivolumab and ipilimumab, patients undergo short-course radiation therapy of 5 fractions daily for 1 week. Patients then continue to receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 8-12 weeks after completion of 4th cycle of nivolumab and ipilimumab, patients undergo TME. Patients also undergo magnetic resonance imaging (MRI) and computed tomography (CT) prior to TME and during follow up, and undergo sigmoidoscopy prior to TME.
After completion of study treatment, patients are followed up for 5 years.
Studietype
Ingrijpend
Inschrijving (Geschat)
31
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Alabama
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Mobile, Alabama, Verenigde Staten, 36607
- Mobile Infirmary Medical Center
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Alaska
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Anchorage, Alaska, Verenigde Staten, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Verenigde Staten, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Verenigde Staten, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Verenigde Staten, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Verenigde Staten, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Verenigde Staten, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Verenigde Staten, 99508
- Providence Alaska Medical Center
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Fort Smith, Arkansas, Verenigde Staten, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, Verenigde Staten, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Arroyo Grande, California, Verenigde Staten, 93420
- PCR Oncology
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Burbank, California, Verenigde Staten, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Los Angeles, California, Verenigde Staten, 90033
- USC / Norris Comprehensive Cancer Center
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Orange, California, Verenigde Staten, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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San Luis Obispo, California, Verenigde Staten, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria, California, Verenigde Staten, 93444
- Mission Hope Medical Oncology - Santa Maria
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Verenigde Staten, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Verenigde Staten, 80210
- AdventHealth Porter
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Lakewood, Colorado, Verenigde Staten, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Verenigde Staten, 80122
- AdventHealth Littleton
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Longmont, Colorado, Verenigde Staten, 80501
- Longmont United Hospital
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Parker, Colorado, Verenigde Staten, 80138
- AdventHealth Parker
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Pueblo, Colorado, Verenigde Staten, 81004
- Saint Mary Corwin Medical Center
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Delaware
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Millville, Delaware, Verenigde Staten, 19967
- Beebe South Coastal Health Campus
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Newark, Delaware, Verenigde Staten, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Verenigde Staten, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Verenigde Staten, 19971
- Beebe Health Campus
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Florida
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Altamonte Springs, Florida, Verenigde Staten, 32701
- AdventHealth Altamonte
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Orlando, Florida, Verenigde Staten, 32803
- AdventHealth Orlando
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Idaho
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Boise, Idaho, Verenigde Staten, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Verenigde Staten, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Verenigde Staten, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Verenigde Staten, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Verenigde Staten, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Verenigde Staten, 83642
- Idaho Urologic Institute-Meridian
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Meridian, Idaho, Verenigde Staten, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Verenigde Staten, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Verenigde Staten, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Verenigde Staten, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Twin Falls, Idaho, Verenigde Staten, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Verenigde Staten, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Verenigde Staten, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, Verenigde Staten, 62902
- Memorial Hospital of Carbondale
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Carterville, Illinois, Verenigde Staten, 62918
- SIH Cancer Institute
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Carthage, Illinois, Verenigde Staten, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Verenigde Staten, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Verenigde Staten, 60612
- University of Illinois
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Danville, Illinois, Verenigde Staten, 61832
- Carle at The Riverfront
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Decatur, Illinois, Verenigde Staten, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Verenigde Staten, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Verenigde Staten, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Verenigde Staten, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Verenigde Staten, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Verenigde Staten, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Verenigde Staten, 61401
- Western Illinois Cancer Treatment Center
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Galesburg, Illinois, Verenigde Staten, 61401
- Illinois CancerCare-Galesburg
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Kewanee, Illinois, Verenigde Staten, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, Verenigde Staten, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Verenigde Staten, 61938
- Carle Physician Group-Mattoon/Charleston
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Mount Vernon, Illinois, Verenigde Staten, 62864
- SSM Health Good Samaritan
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O'Fallon, Illinois, Verenigde Staten, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, Verenigde Staten, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Verenigde Staten, 61554
- Illinois CancerCare-Pekin
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Pekin, Illinois, Verenigde Staten, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, Verenigde Staten, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Verenigde Staten, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Verenigde Staten, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Verenigde Staten, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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Peru, Illinois, Verenigde Staten, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Verenigde Staten, 61354
- Valley Radiation Oncology
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Princeton, Illinois, Verenigde Staten, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Verenigde Staten, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Verenigde Staten, 62702
- Springfield Clinic
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Springfield, Illinois, Verenigde Staten, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Verenigde Staten, 61801
- Carle Cancer Center
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Washington, Illinois, Verenigde Staten, 61571
- Illinois CancerCare - Washington
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Iowa
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Ames, Iowa, Verenigde Staten, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Verenigde Staten, 50010
- McFarland Clinic - Ames
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Carroll, Iowa, Verenigde Staten, 51401
- Saint Anthony Regional Hospital
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Clive, Iowa, Verenigde Staten, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Verenigde Staten, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Creston, Iowa, Verenigde Staten, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Verenigde Staten, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Verenigde Staten, 50314
- Broadlawns Medical Center
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Des Moines, Iowa, Verenigde Staten, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Verenigde Staten, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Verenigde Staten, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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West Des Moines, Iowa, Verenigde Staten, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, Verenigde Staten, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Garden City, Kansas, Verenigde Staten, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Verenigde Staten, 67530
- Central Care Cancer Center - Great Bend
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, Verenigde Staten, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
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Louisville, Kentucky, Verenigde Staten, 40202
- Jewish Hospital
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Louisville, Kentucky, Verenigde Staten, 40245
- UofL Health Medical Center Northeast
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Massachusetts
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Springfield, Massachusetts, Verenigde Staten, 01199
- Baystate Medical Center
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Worcester, Massachusetts, Verenigde Staten, 01655
- UMass Memorial Medical Center - University Campus
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Minnesota
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Burnsville, Minnesota, Verenigde Staten, 55337
- Fairview Ridges Hospital
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Burnsville, Minnesota, Verenigde Staten, 55337
- Minnesota Oncology - Burnsville
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Coon Rapids, Minnesota, Verenigde Staten, 55433
- Mercy Hospital
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Edina, Minnesota, Verenigde Staten, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Verenigde Staten, 55432
- Unity Hospital
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Maple Grove, Minnesota, Verenigde Staten, 55369
- Fairview Clinics and Surgery Center Maple Grove
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Maplewood, Minnesota, Verenigde Staten, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, Verenigde Staten, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Verenigde Staten, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Verenigde Staten, 55407
- Abbott-Northwestern Hospital
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Monticello, Minnesota, Verenigde Staten, 55362
- Monticello Cancer Center
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Robbinsdale, Minnesota, Verenigde Staten, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic in Rochester
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Verenigde Staten, 55101
- Regions Hospital
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Saint Paul, Minnesota, Verenigde Staten, 55102
- United Hospital
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Shakopee, Minnesota, Verenigde Staten, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, Verenigde Staten, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Verenigde Staten, 56201
- Rice Memorial Hospital
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Woodbury, Minnesota, Verenigde Staten, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Missouri
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Ballwin, Missouri, Verenigde Staten, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
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Bolivar, Missouri, Verenigde Staten, 65613
- Central Care Cancer Center - Bolivar
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Cape Girardeau, Missouri, Verenigde Staten, 63703
- Saint Francis Medical Center
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Cape Girardeau, Missouri, Verenigde Staten, 63703
- Mercy Cancer Center - Cape Girardeau
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Farmington, Missouri, Verenigde Staten, 63640
- Parkland Health Center - Farmington
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Jefferson City, Missouri, Verenigde Staten, 65109
- MU Health Care Goldschmidt Cancer Center
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Joplin, Missouri, Verenigde Staten, 64804
- Freeman Health System
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Joplin, Missouri, Verenigde Staten, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Verenigde Staten, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Rolla, Missouri, Verenigde Staten, 65401
- Phelps Health Delbert Day Cancer Institute
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Saint Joseph, Missouri, Verenigde Staten, 64506
- Heartland Regional Medical Center
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Sainte Genevieve, Missouri, Verenigde Staten, 63670
- Sainte Genevieve County Memorial Hospital
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Springfield, Missouri, Verenigde Staten, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Verenigde Staten, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, Verenigde Staten, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Verenigde Staten, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Verenigde Staten, 63128
- Mercy Hospital South
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Sullivan, Missouri, Verenigde Staten, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Billings, Montana, Verenigde Staten, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, Verenigde Staten, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Verenigde Staten, 59405
- Great Falls Clinic
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Great Falls, Montana, Verenigde Staten, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, Verenigde Staten, 59901
- Logan Health Medical Center
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Missoula, Montana, Verenigde Staten, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Verenigde Staten, 59804
- Community Medical Center
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Nebraska
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Grand Island, Nebraska, Verenigde Staten, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
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Kearney, Nebraska, Verenigde Staten, 68847
- CHI Health Good Samaritan
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Omaha, Nebraska, Verenigde Staten, 68124
- Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, Verenigde Staten, 68122
- Alegent Health Immanuel Medical Center
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Omaha, Nebraska, Verenigde Staten, 68130
- Alegent Health Lakeside Hospital
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Nevada
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Henderson, Nevada, Verenigde Staten, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
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Henderson, Nevada, Verenigde Staten, 89074
- Oncology Las Vegas - Henderson
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Las Vegas, Nevada, Verenigde Staten, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, Verenigde Staten, 89106
- Radiation Oncology Centers of Nevada Central
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Las Vegas, Nevada, Verenigde Staten, 89119
- Radiation Oncology Centers of Nevada Southeast
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Las Vegas, Nevada, Verenigde Staten, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
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Las Vegas, Nevada, Verenigde Staten, 89128
- OptumCare Cancer Care at MountainView
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Las Vegas, Nevada, Verenigde Staten, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, Verenigde Staten, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
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Las Vegas, Nevada, Verenigde Staten, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
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Las Vegas, Nevada, Verenigde Staten, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Verenigde Staten, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
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Las Vegas, Nevada, Verenigde Staten, 89183
- OptumCare Cancer Care at Fort Apache
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Reno, Nevada, Verenigde Staten, 89502
- Renown Regional Medical Center
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Reno, Nevada, Verenigde Staten, 89503
- Saint Mary's Regional Medical Center
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Reno, Nevada, Verenigde Staten, 89509
- Radiation Oncology Associates
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New Hampshire
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Concord, New Hampshire, Verenigde Staten, 03301
- New Hampshire Oncology Hematology PA-Concord
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Lebanon, New Hampshire, Verenigde Staten, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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Manchester, New Hampshire, Verenigde Staten, 03103
- Solinsky Center for Cancer Care
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New York
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Lake Success, New York, Verenigde Staten, 11042
- Northwell Health/Center for Advanced Medicine
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Middletown, New York, Verenigde Staten, 10940
- Garnet Health Medical Center
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Mount Kisco, New York, Verenigde Staten, 10549
- Northern Westchester Hospital
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New York, New York, Verenigde Staten, 10075
- Lenox Hill Hospital
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New York, New York, Verenigde Staten, 10065
- Manhattan Eye Ear and Throat Hospital
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45220
- Good Samaritan Hospital - Cincinnati
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Cincinnati, Ohio, Verenigde Staten, 45242
- Bethesda North Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Verenigde Staten, 73120
- Mercy Hospital Oklahoma City
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Oregon
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Bend, Oregon, Verenigde Staten, 97701
- Saint Charles Health System
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Clackamas, Oregon, Verenigde Staten, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, Verenigde Staten, 97015
- Providence Cancer Institute Clackamas Clinic
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Coos Bay, Oregon, Verenigde Staten, 97420
- Bay Area Hospital
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Newberg, Oregon, Verenigde Staten, 97132
- Providence Newberg Medical Center
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Portland, Oregon, Verenigde Staten, 97213
- Providence Portland Medical Center
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Portland, Oregon, Verenigde Staten, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Chadds Ford, Pennsylvania, Verenigde Staten, 19317
- Christiana Care Health System-Concord Health Center
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South Dakota
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Rapid City, South Dakota, Verenigde Staten, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Verenigde Staten, 57105
- Avera Cancer Institute
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37232
- Vanderbilt University/Ingram Cancer Center
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Nashville, Tennessee, Verenigde Staten, 37204
- Vanderbilt Breast Center at One Hundred Oaks
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Texas
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Bryan, Texas, Verenigde Staten, 77802
- Saint Joseph Regional Cancer Center
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Vermont
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Saint Johnsbury, Vermont, Verenigde Staten, 05819
- Dartmouth Cancer Center - North
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Washington
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Aberdeen, Washington, Verenigde Staten, 98520
- Providence Regional Cancer System-Aberdeen
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Bellevue, Washington, Verenigde Staten, 98004
- Overlake Medical Center
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Bellingham, Washington, Verenigde Staten, 98225
- PeaceHealth Saint Joseph Medical Center
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Burien, Washington, Verenigde Staten, 98166
- Saint Anne Hospital
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Centralia, Washington, Verenigde Staten, 98531
- Providence Regional Cancer System-Centralia
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Edmonds, Washington, Verenigde Staten, 98026
- Swedish Cancer Institute-Edmonds
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Everett, Washington, Verenigde Staten, 98201
- Providence Regional Cancer Partnership
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Issaquah, Washington, Verenigde Staten, 98029
- Swedish Cancer Institute-Issaquah
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Lacey, Washington, Verenigde Staten, 98503
- Providence Regional Cancer System-Lacey
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Longview, Washington, Verenigde Staten, 98632
- PeaceHealth Saint John Medical Center
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Renton, Washington, Verenigde Staten, 98055
- Valley Medical Center
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Seattle, Washington, Verenigde Staten, 98107
- Swedish Medical Center-Ballard Campus
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Seattle, Washington, Verenigde Staten, 98122
- Swedish Medical Center-First Hill
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Sedro-Woolley, Washington, Verenigde Staten, 98284
- PeaceHealth United General Medical Center
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Silverdale, Washington, Verenigde Staten, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
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Vancouver, Washington, Verenigde Staten, 98664
- PeaceHealth Southwest Medical Center
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Walla Walla, Washington, Verenigde Staten, 99362
- Providence Saint Mary Regional Cancer Center
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Yakima, Washington, Verenigde Staten, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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Wisconsin
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Appleton, Wisconsin, Verenigde Staten, 54911
- ThedaCare Regional Cancer Center
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New Richmond, Wisconsin, Verenigde Staten, 54017
- Cancer Center of Western Wisconsin
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Wyoming
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Sheridan, Wyoming, Verenigde Staten, 82801
- Welch Cancer Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Patient must be >= 18 years of age
- Patient must have histologically confirmed adenocarcinoma of the rectum with the inferior margin within 15 cm from the anal verge based on colonoscopy and/or flexible sigmoidoscopy
- Patient must have T3-4Nx or TxN+ disease (stage II or III) based on magnetic resonance imaging of the pelvis and computed tomography of the chest and abdomen. These baseline scans must be done within 28 days prior to registration
- Patient must have MSI-H (microsatellite instability-high) or dMMR (deficient mismatch repair) tumors based on immunohistochemistry or PCR (polymerase chain reaction)
- Patient must have Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- Patient must not have previously received chemotherapy or immunotherapy for rectal cancer
- Patient must not have previously received radiotherapy to the pelvis
- Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
- Patient must not have had major surgery performed within 28 days prior to registration
- Patient must not have a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan
- Patient must not have a serious active infection requiring IV antibiotics at time of registration
- Patient must agree to not receive live vaccines while on this study
- Patient must not have active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater). 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, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or anti-phospholipid syndrome. Patients with any of these are ineligible for this study because of the risk of recurrence or exacerbation of disease
- Patient must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids and adrenal replacement doses < 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if < 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A repeat pregnancy test must be done within 72 hours prior to first dose of treatment if the baseline test was done outside the 72 hour window. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Patients of childbearing potential and sexually active patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for at least one month (female patients) or one week (male patients) prior to the start of study drug and continue for 5 months after the last dose of study drug (for female patients). Investigators must counsel patients on the importance of pregnancy prevention and the implications of an unexpected pregnancy
- Leukocytes >= 3,000/mcL (must be obtained =< 14 days prior to protocol registration)
- Absolute neutrophil count (ANC) >= 1,500/mcL (must be obtained =< 14 days prior to protocol registration)
- Platelets >= 100,000/mcL (must be obtained =< 14 days prior to protocol registration)
- Total bilirubin =< institutional upper limit of normal (ULN) (must be obtained =< 14 days prior to protocol registration)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional ULN (must be obtained =< 14 days prior to protocol registration)
- Creatinine =< 1.5 x institutional ULN (must be obtained =< 14 days prior to protocol registration)
- Patients should have urine dipstick with proteinuria < 1. If urine dipstick > 2, proteinuria must be less than 1 g in 24 hours urine collection
- 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
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable 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 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
- 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
- Patient must not have had live vaccines within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Patients are permitted to receive inactivated vaccines and any non-live vaccines including those for the seasonal influenza and COVID-19 (Note: intranasal influenza vaccines, such as Flu-Mist [registered trademark] are live attenuated vaccines and are not allowed). If possible, it is recommended to separate study drug administration from vaccine administration by about a week (primarily, in order to minimize an overlap of adverse events)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Treatment (nivolumab, ipilimumab, radiation therapy, TME)
Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for 2 cycles. Starting at least 2 weeks but no longer than 6 weeks after completion of cycle 2 of nivolumab and ipilimumab, patients undergo short-course radiation therapy of 5 fractions daily for 1 week. Patients then continue to receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 8-12 weeks after completion of 4th cycle of nivolumab and ipilimumab, patients undergo TME. Patients also undergo MRI and CT prior to TME and during follow up, and undergo sigmoidoscopy prior to TME. |
Given IV
Andere namen:
Undergo CT
Andere namen:
Undergo MRI
Andere namen:
Given IV
Andere namen:
Undergo sigmoidoscopy
Andere namen:
Undergo short-course radiation therapy
Andere namen:
Undergo TME
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Pathologische volledige respons
Tijdsspanne: Op het moment van totale mesorectale excisie
|
Op het moment van totale mesorectale excisie
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Rate of sphincter preservation in low-lying tumors
Tijdsspanne: Up to 5 years
|
95% confidence interval will be estimated. |
Up to 5 years
|
|
Disease free survival
Tijdsspanne: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Overall survival
Tijdsspanne: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Incidence of adverse events
Tijdsspanne: Up to 5 years
|
Will be assessed by Common Terminology Criteria for Adverse Events 5.0. Toxicities will be tabulated by grade and treatment relation. |
Up to 5 years
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Kristen K Ciombor, ECOG-ACRIN Cancer Research Group
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
8 februari 2022
Primaire voltooiing (Geschat)
30 juni 2027
Studie voltooiing (Geschat)
30 juni 2027
Studieregistratiedata
Eerst ingediend
11 februari 2021
Eerst ingediend dat voldeed aan de QC-criteria
11 februari 2021
Eerst geplaatst (Werkelijk)
12 februari 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
22 oktober 2026
Laatste update ingediend die voldeed aan QC-criteria
21 oktober 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Darmziekten
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Colorectale neoplasmata
- Intestinale neoplasmata
- Rectale ziekten
- Rectale neoplasmata
- Aminozuren, peptiden en eiwitten
- Eiwitten
- Onderzoekstechnieken
- Therapeutica
- Diagnostische technieken en procedures
- Diagnose
- Chirurgische procedures, operatief
- Minimaal invasieve chirurgische procedures
- Biologische factoren
- Fysieke fenomeen
- Antilichamen, monoklonaal, gehumaniseerd
- Antilichamen, monoklonaal
- Antilichamen
- Immunoglobulinen
- Immunoproteïnen
- Bloedeiwitten
- Serum -globulines
- Globulines
- Diagnostische technieken, chirurgisch
- Endoscopie, gastro -intestinaal
- Endoscopie, spijsverteringssysteem
- Diagnostische technieken, spijsverteringssysteem
- Endoscopie
- Chirurgische procedures van het spijsverteringssysteem
- Chemie -technieken, analytisch
- Spectrumanalyse
- Receptoren, celoppervlak
- Membraaneiwitten
- Antigenen
- Colonoscopie
- Antigenen, oppervlak
- Biomarkers
- Receptoren, immunologisch
- Antigenen, differentiatie, T-lymfocyt
- Antigenen, differentiatie
- Immuun checkpoint -eiwitten
- Costimulatoire en remmende T-celreceptoren
- Nivolumab
- Ipilimumab
- Radiotherapie
- Bestraling
- Magnetische resonantiespectroscopie
- Sigmoïdoscopie
- CTLA-4 antigeen
Andere studie-ID-nummers
- NCI-2021-00912
- U10CA180820 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2021-00912 (Register-ID: CTRP (Clinical Trial Reporting Program))
- EA2201 (Andere identificatie: CTEP)
- EA2201 (Andere identificatie: ECOG-ACRIN Cancer Research Group)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .