Test du nivolumab et de l'ipilimumab avec une radiothérapie de courte durée dans le cancer rectal localement avancé
21 octobre 2026 mis à jour par: National Cancer Institute (NCI)
Une étude de phase II sur le nivolumab néoadjuvant plus ipilimumab et la radiothérapie de courte durée dans l'adénocarcinome rectal localement avancé MSI-H/dMMR
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.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
31
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Mobile, Alabama, États-Unis, 36607
- Mobile Infirmary Medical Center
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Alaska
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Anchorage, Alaska, États-Unis, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, États-Unis, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, États-Unis, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, États-Unis, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, États-Unis, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, États-Unis, 99508
- Katmai Oncology Group
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Anchorage, Alaska, États-Unis, 99508
- Providence Alaska Medical Center
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Arizona
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Phoenix, Arizona, États-Unis, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Fort Smith, Arkansas, États-Unis, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, États-Unis, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Arroyo Grande, California, États-Unis, 93420
- PCR Oncology
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Burbank, California, États-Unis, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Los Angeles, California, États-Unis, 90033
- USC / Norris Comprehensive Cancer Center
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Orange, California, États-Unis, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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San Luis Obispo, California, États-Unis, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria, California, États-Unis, 93444
- Mission Hope Medical Oncology - Santa Maria
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Colorado
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Colorado Springs, Colorado, États-Unis, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, États-Unis, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, États-Unis, 80210
- AdventHealth Porter
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Lakewood, Colorado, États-Unis, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, États-Unis, 80122
- AdventHealth Littleton
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Longmont, Colorado, États-Unis, 80501
- Longmont United Hospital
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Parker, Colorado, États-Unis, 80138
- AdventHealth Parker
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Pueblo, Colorado, États-Unis, 81004
- Saint Mary Corwin Medical Center
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Delaware
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Millville, Delaware, États-Unis, 19967
- Beebe South Coastal Health Campus
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Newark, Delaware, États-Unis, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, États-Unis, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, États-Unis, 19971
- Beebe Health Campus
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Florida
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Altamonte Springs, Florida, États-Unis, 32701
- AdventHealth Altamonte
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Orlando, Florida, États-Unis, 32803
- AdventHealth Orlando
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Idaho
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Boise, Idaho, États-Unis, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, États-Unis, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, États-Unis, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, États-Unis, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, États-Unis, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, États-Unis, 83642
- Idaho Urologic Institute-Meridian
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Meridian, Idaho, États-Unis, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, États-Unis, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, États-Unis, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, États-Unis, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Twin Falls, Idaho, États-Unis, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, États-Unis, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, États-Unis, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, États-Unis, 62902
- Memorial Hospital of Carbondale
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Carterville, Illinois, États-Unis, 62918
- SIH Cancer Institute
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Carthage, Illinois, États-Unis, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, États-Unis, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, États-Unis, 60612
- University of Illinois
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Danville, Illinois, États-Unis, 61832
- Carle at The Riverfront
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Decatur, Illinois, États-Unis, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, États-Unis, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, États-Unis, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, États-Unis, 62401
- Crossroads Cancer Center
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Effingham, Illinois, États-Unis, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, États-Unis, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, États-Unis, 61401
- Western Illinois Cancer Treatment Center
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Galesburg, Illinois, États-Unis, 61401
- Illinois CancerCare-Galesburg
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Kewanee, Illinois, États-Unis, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, États-Unis, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, États-Unis, 61938
- Carle Physician Group-Mattoon/Charleston
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Mount Vernon, Illinois, États-Unis, 62864
- SSM Health Good Samaritan
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O'Fallon, Illinois, États-Unis, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, États-Unis, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, États-Unis, 61554
- Illinois CancerCare-Pekin
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Pekin, Illinois, États-Unis, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, États-Unis, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, États-Unis, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, États-Unis, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, États-Unis, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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Peru, Illinois, États-Unis, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, États-Unis, 61354
- Valley Radiation Oncology
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Princeton, Illinois, États-Unis, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, États-Unis, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, États-Unis, 62702
- Springfield Clinic
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Springfield, Illinois, États-Unis, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, États-Unis, 61801
- Carle Cancer Center
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Washington, Illinois, États-Unis, 61571
- Illinois CancerCare - Washington
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Iowa
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Ames, Iowa, États-Unis, 50010
- Mary Greeley Medical Center
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Ames, Iowa, États-Unis, 50010
- McFarland Clinic - Ames
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Carroll, Iowa, États-Unis, 51401
- Saint Anthony Regional Hospital
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Clive, Iowa, États-Unis, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, États-Unis, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Creston, Iowa, États-Unis, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, États-Unis, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, États-Unis, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, États-Unis, 50314
- Broadlawns Medical Center
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Des Moines, Iowa, États-Unis, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, États-Unis, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, États-Unis, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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West Des Moines, Iowa, États-Unis, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, États-Unis, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Garden City, Kansas, États-Unis, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, États-Unis, 67530
- Central Care Cancer Center - Great Bend
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Kentucky
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Lexington, Kentucky, États-Unis, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, États-Unis, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
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Louisville, Kentucky, États-Unis, 40202
- Jewish Hospital
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Louisville, Kentucky, États-Unis, 40245
- UofL Health Medical Center Northeast
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Massachusetts
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Springfield, Massachusetts, États-Unis, 01199
- Baystate Medical Center
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Worcester, Massachusetts, États-Unis, 01655
- UMass Memorial Medical Center - University Campus
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Minnesota
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Burnsville, Minnesota, États-Unis, 55337
- Fairview Ridges Hospital
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Burnsville, Minnesota, États-Unis, 55337
- Minnesota Oncology - Burnsville
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Coon Rapids, Minnesota, États-Unis, 55433
- Mercy Hospital
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Edina, Minnesota, États-Unis, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, États-Unis, 55432
- Unity Hospital
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Maple Grove, Minnesota, États-Unis, 55369
- Fairview Clinics and Surgery Center Maple Grove
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Maplewood, Minnesota, États-Unis, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, États-Unis, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, États-Unis, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, États-Unis, 55407
- Abbott-Northwestern Hospital
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Monticello, Minnesota, États-Unis, 55362
- Monticello Cancer Center
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Robbinsdale, Minnesota, États-Unis, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic in Rochester
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Saint Louis Park, Minnesota, États-Unis, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, États-Unis, 55101
- Regions Hospital
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Saint Paul, Minnesota, États-Unis, 55102
- United Hospital
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Shakopee, Minnesota, États-Unis, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, États-Unis, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, États-Unis, 56201
- Rice Memorial Hospital
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Woodbury, Minnesota, États-Unis, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Missouri
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Ballwin, Missouri, États-Unis, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
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Bolivar, Missouri, États-Unis, 65613
- Central Care Cancer Center - Bolivar
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Cape Girardeau, Missouri, États-Unis, 63703
- Saint Francis Medical Center
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Cape Girardeau, Missouri, États-Unis, 63703
- Mercy Cancer Center - Cape Girardeau
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Farmington, Missouri, États-Unis, 63640
- Parkland Health Center - Farmington
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Jefferson City, Missouri, États-Unis, 65109
- MU Health Care Goldschmidt Cancer Center
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Joplin, Missouri, États-Unis, 64804
- Freeman Health System
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Joplin, Missouri, États-Unis, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, États-Unis, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Rolla, Missouri, États-Unis, 65401
- Phelps Health Delbert Day Cancer Institute
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Saint Joseph, Missouri, États-Unis, 64506
- Heartland Regional Medical Center
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Sainte Genevieve, Missouri, États-Unis, 63670
- Sainte Genevieve County Memorial Hospital
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Springfield, Missouri, États-Unis, 65807
- CoxHealth South Hospital
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Springfield, Missouri, États-Unis, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, États-Unis, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, États-Unis, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, États-Unis, 63128
- Mercy Hospital South
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Sullivan, Missouri, États-Unis, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Billings, Montana, États-Unis, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, États-Unis, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, États-Unis, 59405
- Great Falls Clinic
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Great Falls, Montana, États-Unis, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, États-Unis, 59901
- Logan Health Medical Center
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Missoula, Montana, États-Unis, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, États-Unis, 59804
- Community Medical Center
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Nebraska
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Grand Island, Nebraska, États-Unis, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
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Kearney, Nebraska, États-Unis, 68847
- CHI Health Good Samaritan
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Omaha, Nebraska, États-Unis, 68124
- Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, États-Unis, 68122
- Alegent Health Immanuel Medical Center
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Omaha, Nebraska, États-Unis, 68130
- Alegent Health Lakeside Hospital
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Nevada
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Henderson, Nevada, États-Unis, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
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Henderson, Nevada, États-Unis, 89074
- Oncology Las Vegas - Henderson
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Las Vegas, Nevada, États-Unis, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, États-Unis, 89106
- Radiation Oncology Centers of Nevada Central
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Las Vegas, Nevada, États-Unis, 89119
- Radiation Oncology Centers of Nevada Southeast
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Las Vegas, Nevada, États-Unis, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
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Las Vegas, Nevada, États-Unis, 89128
- OptumCare Cancer Care at MountainView
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Las Vegas, Nevada, États-Unis, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, États-Unis, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
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Las Vegas, Nevada, États-Unis, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
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Las Vegas, Nevada, États-Unis, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, États-Unis, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
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Las Vegas, Nevada, États-Unis, 89183
- OptumCare Cancer Care at Fort Apache
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Reno, Nevada, États-Unis, 89502
- Renown Regional Medical Center
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Reno, Nevada, États-Unis, 89503
- Saint Mary's Regional Medical Center
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Reno, Nevada, États-Unis, 89509
- Radiation Oncology Associates
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New Hampshire
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Concord, New Hampshire, États-Unis, 03301
- New Hampshire Oncology Hematology PA-Concord
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Lebanon, New Hampshire, États-Unis, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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Manchester, New Hampshire, États-Unis, 03103
- Solinsky Center for Cancer Care
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New York
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Lake Success, New York, États-Unis, 11042
- Northwell Health/Center for Advanced Medicine
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Middletown, New York, États-Unis, 10940
- Garnet Health Medical Center
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Mount Kisco, New York, États-Unis, 10549
- Northern Westchester Hospital
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New York, New York, États-Unis, 10075
- Lenox Hill Hospital
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New York, New York, États-Unis, 10065
- Manhattan Eye Ear and Throat Hospital
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Ohio
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Cincinnati, Ohio, États-Unis, 45220
- Good Samaritan Hospital - Cincinnati
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Cincinnati, Ohio, États-Unis, 45242
- Bethesda North Hospital
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, États-Unis, 73120
- Mercy Hospital Oklahoma City
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Oregon
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Bend, Oregon, États-Unis, 97701
- Saint Charles Health System
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Clackamas, Oregon, États-Unis, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, États-Unis, 97015
- Providence Cancer Institute Clackamas Clinic
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Coos Bay, Oregon, États-Unis, 97420
- Bay Area Hospital
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Newberg, Oregon, États-Unis, 97132
- Providence Newberg Medical Center
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Portland, Oregon, États-Unis, 97213
- Providence Portland Medical Center
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Portland, Oregon, États-Unis, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Chadds Ford, Pennsylvania, États-Unis, 19317
- Christiana Care Health System-Concord Health Center
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South Dakota
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Rapid City, South Dakota, États-Unis, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, États-Unis, 57105
- Avera Cancer Institute
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Tennessee
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Nashville, Tennessee, États-Unis, 37232
- Vanderbilt University/Ingram Cancer Center
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Nashville, Tennessee, États-Unis, 37204
- Vanderbilt Breast Center at One Hundred Oaks
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Texas
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Bryan, Texas, États-Unis, 77802
- Saint Joseph Regional Cancer Center
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Vermont
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Saint Johnsbury, Vermont, États-Unis, 05819
- Dartmouth Cancer Center - North
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Washington
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Aberdeen, Washington, États-Unis, 98520
- Providence Regional Cancer System-Aberdeen
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Bellevue, Washington, États-Unis, 98004
- Overlake Medical Center
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Bellingham, Washington, États-Unis, 98225
- PeaceHealth Saint Joseph Medical Center
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Burien, Washington, États-Unis, 98166
- Saint Anne Hospital
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Centralia, Washington, États-Unis, 98531
- Providence Regional Cancer System-Centralia
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Edmonds, Washington, États-Unis, 98026
- Swedish Cancer Institute-Edmonds
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Everett, Washington, États-Unis, 98201
- Providence Regional Cancer Partnership
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Issaquah, Washington, États-Unis, 98029
- Swedish Cancer Institute-Issaquah
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Lacey, Washington, États-Unis, 98503
- Providence Regional Cancer System-Lacey
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Longview, Washington, États-Unis, 98632
- PeaceHealth Saint John Medical Center
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Renton, Washington, États-Unis, 98055
- Valley Medical Center
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Seattle, Washington, États-Unis, 98107
- Swedish Medical Center-Ballard Campus
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Seattle, Washington, États-Unis, 98122
- Swedish Medical Center-First Hill
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Sedro-Woolley, Washington, États-Unis, 98284
- PeaceHealth United General Medical Center
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Silverdale, Washington, États-Unis, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
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Vancouver, Washington, États-Unis, 98664
- PeaceHealth Southwest Medical Center
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Walla Walla, Washington, États-Unis, 99362
- Providence Saint Mary Regional Cancer Center
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Yakima, Washington, États-Unis, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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Wisconsin
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Appleton, Wisconsin, États-Unis, 54911
- ThedaCare Regional Cancer Center
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New Richmond, Wisconsin, États-Unis, 54017
- Cancer Center of Western Wisconsin
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Wyoming
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Sheridan, Wyoming, États-Unis, 82801
- Welch Cancer Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
Undergo CT
Autres noms:
Undergo MRI
Autres noms:
Given IV
Autres noms:
Undergo sigmoidoscopy
Autres noms:
Undergo short-course radiation therapy
Autres noms:
Undergo TME
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Réponse complète pathologique
Délai: Au moment de l'exérèse mésorectale totale
|
Au moment de l'exérèse mésorectale totale
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rate of sphincter preservation in low-lying tumors
Délai: Up to 5 years
|
95% confidence interval will be estimated. |
Up to 5 years
|
|
Disease free survival
Délai: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Overall survival
Délai: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Incidence of adverse events
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Kristen K Ciombor, ECOG-ACRIN Cancer Research Group
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 février 2022
Achèvement primaire (Estimé)
30 juin 2027
Achèvement de l'étude (Estimé)
30 juin 2027
Dates d'inscription aux études
Première soumission
11 février 2021
Première soumission répondant aux critères de contrôle qualité
11 février 2021
Première publication (Réel)
12 février 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 octobre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 octobre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Maladies intestinales
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies gastro-intestinales
- Tumeurs colorectales
- Tumeurs intestinales
- Maladies rectales
- Tumeurs rectales
- Acides aminés, peptides et protéines
- Protéines
- Techniques d'investigation
- Thérapeutique
- Techniques et procédures de diagnostic
- Diagnostic
- Procédures chirurgicales, opératoires
- Procédures chirurgicales mini-invasives
- Facteurs biologiques
- Phénomènes physiques
- Anticorps, monoclonal, humanisé
- Anticorps, monoclonal
- Anticorps
- Immunoglobulines
- Immunoprotéines
- Protéines sanguines
- Globulines sériques
- Globulines
- Techniques de diagnostic, chirurgicale
- Endoscopie, gastro-intestinal
- Endoscopie, système digestif
- Techniques de diagnostic, système digestif
- Endoscopie
- Procédures chirurgicales du système digestif
- Techniques de chimie, analytique
- Analyse du spectre
- Récepteurs, surface cellulaire
- Protéines membranaires
- Antigènes
- Coloscopie
- Antigènes, surface
- Biomarqueurs
- Récepteurs, immunologique
- Antigènes, différenciation, lymphocyte T
- Antigènes, différenciation
- Protéines de point de contrôle immunitaire
- Récepteurs costimulants et inhibiteurs des cellules T
- Nivolumab
- Ipilimumab
- Radiothérapie
- Radiation
- Spectroscopie de résonance magnétique
- Sigmoïdoscopie
- Antigène CTLA-4
Autres numéros d'identification d'étude
- NCI-2021-00912
- U10CA180820 (Subvention/contrat des NIH des États-Unis)
- NCI-2021-00912 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- EA2201 (Autre identifiant: CTEP)
- EA2201 (Autre identifiant: ECOG-ACRIN Cancer Research Group)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .