Prueba de nivolumab e ipilimumab con radiación de corta duración en el cáncer de recto localmente avanzado
21 de octubre de 2026 actualizado por: National Cancer Institute (NCI)
Un estudio de fase II de neoadyuvante nivolumab más ipilimumab y radiación de corta duración en MSI-H/dMMR adenocarcinoma rectal localmente avanzado
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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
31
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alabama
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Mobile, Alabama, Estados Unidos, 36607
- Mobile Infirmary Medical Center
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Alaska
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Anchorage, Alaska, Estados Unidos, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Estados Unidos, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Estados Unidos, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Estados Unidos, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Estados Unidos, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Estados Unidos, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Estados Unidos, 99508
- Providence Alaska Medical Center
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Arizona
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Phoenix, Arizona, Estados Unidos, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Fort Smith, Arkansas, Estados Unidos, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, Estados Unidos, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Arroyo Grande, California, Estados Unidos, 93420
- PCR Oncology
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Burbank, California, Estados Unidos, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Los Angeles, California, Estados Unidos, 90033
- USC / Norris Comprehensive Cancer Center
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Orange, California, Estados Unidos, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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San Luis Obispo, California, Estados Unidos, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria, California, Estados Unidos, 93444
- Mission Hope Medical Oncology - Santa Maria
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Estados Unidos, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Estados Unidos, 80210
- AdventHealth Porter
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Lakewood, Colorado, Estados Unidos, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Estados Unidos, 80122
- AdventHealth Littleton
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Longmont, Colorado, Estados Unidos, 80501
- Longmont United Hospital
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Parker, Colorado, Estados Unidos, 80138
- AdventHealth Parker
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Pueblo, Colorado, Estados Unidos, 81004
- Saint Mary Corwin Medical Center
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Delaware
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Millville, Delaware, Estados Unidos, 19967
- Beebe South Coastal Health Campus
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Newark, Delaware, Estados Unidos, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Estados Unidos, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Estados Unidos, 19971
- Beebe Health Campus
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Florida
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Altamonte Springs, Florida, Estados Unidos, 32701
- AdventHealth Altamonte
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Orlando, Florida, Estados Unidos, 32803
- AdventHealth Orlando
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Idaho
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Boise, Idaho, Estados Unidos, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Estados Unidos, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Estados Unidos, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Estados Unidos, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Estados Unidos, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Estados Unidos, 83642
- Idaho Urologic Institute-Meridian
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Meridian, Idaho, Estados Unidos, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Estados Unidos, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Estados Unidos, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Estados Unidos, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Twin Falls, Idaho, Estados Unidos, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Estados Unidos, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Estados Unidos, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, Estados Unidos, 62902
- Memorial Hospital of Carbondale
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Carterville, Illinois, Estados Unidos, 62918
- SIH Cancer Institute
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Carthage, Illinois, Estados Unidos, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Estados Unidos, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Estados Unidos, 60612
- University of Illinois
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Danville, Illinois, Estados Unidos, 61832
- Carle at The Riverfront
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Decatur, Illinois, Estados Unidos, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Estados Unidos, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Estados Unidos, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Estados Unidos, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Estados Unidos, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Estados Unidos, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Estados Unidos, 61401
- Western Illinois Cancer Treatment Center
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Galesburg, Illinois, Estados Unidos, 61401
- Illinois CancerCare-Galesburg
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Kewanee, Illinois, Estados Unidos, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, Estados Unidos, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Estados Unidos, 61938
- Carle Physician Group-Mattoon/Charleston
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Mount Vernon, Illinois, Estados Unidos, 62864
- SSM Health Good Samaritan
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O'Fallon, Illinois, Estados Unidos, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, Estados Unidos, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Estados Unidos, 61554
- Illinois CancerCare-Pekin
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Pekin, Illinois, Estados Unidos, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, Estados Unidos, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Estados Unidos, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Estados Unidos, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Estados Unidos, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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Peru, Illinois, Estados Unidos, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Estados Unidos, 61354
- Valley Radiation Oncology
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Princeton, Illinois, Estados Unidos, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Estados Unidos, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Estados Unidos, 62702
- Springfield Clinic
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Springfield, Illinois, Estados Unidos, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Estados Unidos, 61801
- Carle Cancer Center
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Washington, Illinois, Estados Unidos, 61571
- Illinois CancerCare - Washington
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Iowa
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Ames, Iowa, Estados Unidos, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Estados Unidos, 50010
- McFarland Clinic - Ames
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Carroll, Iowa, Estados Unidos, 51401
- Saint Anthony Regional Hospital
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Clive, Iowa, Estados Unidos, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Estados Unidos, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Creston, Iowa, Estados Unidos, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Estados Unidos, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Estados Unidos, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Estados Unidos, 50314
- Broadlawns Medical Center
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Des Moines, Iowa, Estados Unidos, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Estados Unidos, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Estados Unidos, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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West Des Moines, Iowa, Estados Unidos, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, Estados Unidos, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Garden City, Kansas, Estados Unidos, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Estados Unidos, 67530
- Central Care Cancer Center - Great Bend
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, Estados Unidos, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
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Louisville, Kentucky, Estados Unidos, 40202
- Jewish Hospital
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Louisville, Kentucky, Estados Unidos, 40245
- UofL Health Medical Center Northeast
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Massachusetts
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Springfield, Massachusetts, Estados Unidos, 01199
- Baystate Medical Center
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Worcester, Massachusetts, Estados Unidos, 01655
- UMass Memorial Medical Center - University Campus
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Minnesota
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Burnsville, Minnesota, Estados Unidos, 55337
- Fairview Ridges Hospital
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Burnsville, Minnesota, Estados Unidos, 55337
- Minnesota Oncology - Burnsville
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Coon Rapids, Minnesota, Estados Unidos, 55433
- Mercy Hospital
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Edina, Minnesota, Estados Unidos, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Estados Unidos, 55432
- Unity Hospital
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Maple Grove, Minnesota, Estados Unidos, 55369
- Fairview Clinics and Surgery Center Maple Grove
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Maplewood, Minnesota, Estados Unidos, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, Estados Unidos, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Estados Unidos, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Estados Unidos, 55407
- Abbott-Northwestern Hospital
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Monticello, Minnesota, Estados Unidos, 55362
- Monticello Cancer Center
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Robbinsdale, Minnesota, Estados Unidos, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic in Rochester
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Estados Unidos, 55101
- Regions Hospital
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Saint Paul, Minnesota, Estados Unidos, 55102
- United Hospital
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Shakopee, Minnesota, Estados Unidos, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, Estados Unidos, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Estados Unidos, 56201
- Rice Memorial Hospital
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Woodbury, Minnesota, Estados Unidos, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Missouri
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Ballwin, Missouri, Estados Unidos, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
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Bolivar, Missouri, Estados Unidos, 65613
- Central Care Cancer Center - Bolivar
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Cape Girardeau, Missouri, Estados Unidos, 63703
- Saint Francis Medical Center
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Cape Girardeau, Missouri, Estados Unidos, 63703
- Mercy Cancer Center - Cape Girardeau
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Farmington, Missouri, Estados Unidos, 63640
- Parkland Health Center - Farmington
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Jefferson City, Missouri, Estados Unidos, 65109
- MU Health Care Goldschmidt Cancer Center
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Joplin, Missouri, Estados Unidos, 64804
- Freeman Health System
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Joplin, Missouri, Estados Unidos, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Estados Unidos, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Rolla, Missouri, Estados Unidos, 65401
- Phelps Health Delbert Day Cancer Institute
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Saint Joseph, Missouri, Estados Unidos, 64506
- Heartland Regional Medical Center
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Sainte Genevieve, Missouri, Estados Unidos, 63670
- Sainte Genevieve County Memorial Hospital
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Springfield, Missouri, Estados Unidos, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Estados Unidos, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, Estados Unidos, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Estados Unidos, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Estados Unidos, 63128
- Mercy Hospital South
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Sullivan, Missouri, Estados Unidos, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Billings, Montana, Estados Unidos, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, Estados Unidos, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Estados Unidos, 59405
- Great Falls Clinic
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Great Falls, Montana, Estados Unidos, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, Estados Unidos, 59901
- Logan Health Medical Center
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Missoula, Montana, Estados Unidos, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Estados Unidos, 59804
- Community Medical Center
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Nebraska
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Grand Island, Nebraska, Estados Unidos, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
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Kearney, Nebraska, Estados Unidos, 68847
- CHI Health Good Samaritan
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Omaha, Nebraska, Estados Unidos, 68124
- Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, Estados Unidos, 68122
- Alegent Health Immanuel Medical Center
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Omaha, Nebraska, Estados Unidos, 68130
- Alegent Health Lakeside Hospital
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Nevada
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Henderson, Nevada, Estados Unidos, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
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Henderson, Nevada, Estados Unidos, 89074
- Oncology Las Vegas - Henderson
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Las Vegas, Nevada, Estados Unidos, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, Estados Unidos, 89106
- Radiation Oncology Centers of Nevada Central
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Las Vegas, Nevada, Estados Unidos, 89119
- Radiation Oncology Centers of Nevada Southeast
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Las Vegas, Nevada, Estados Unidos, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
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Las Vegas, Nevada, Estados Unidos, 89128
- OptumCare Cancer Care at MountainView
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Las Vegas, Nevada, Estados Unidos, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, Estados Unidos, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
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Las Vegas, Nevada, Estados Unidos, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
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Las Vegas, Nevada, Estados Unidos, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Estados Unidos, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
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Las Vegas, Nevada, Estados Unidos, 89183
- OptumCare Cancer Care at Fort Apache
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Reno, Nevada, Estados Unidos, 89502
- Renown Regional Medical Center
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Reno, Nevada, Estados Unidos, 89503
- Saint Mary's Regional Medical Center
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Reno, Nevada, Estados Unidos, 89509
- Radiation Oncology Associates
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New Hampshire
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Concord, New Hampshire, Estados Unidos, 03301
- New Hampshire Oncology Hematology PA-Concord
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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Manchester, New Hampshire, Estados Unidos, 03103
- Solinsky Center for Cancer Care
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New York
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Lake Success, New York, Estados Unidos, 11042
- Northwell Health/Center for Advanced Medicine
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Middletown, New York, Estados Unidos, 10940
- Garnet Health Medical Center
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Mount Kisco, New York, Estados Unidos, 10549
- Northern Westchester Hospital
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New York, New York, Estados Unidos, 10075
- Lenox Hill Hospital
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New York, New York, Estados Unidos, 10065
- Manhattan Eye Ear and Throat Hospital
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45220
- Good Samaritan Hospital - Cincinnati
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Cincinnati, Ohio, Estados Unidos, 45242
- Bethesda North Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Estados Unidos, 73120
- Mercy Hospital Oklahoma City
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Oregon
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Bend, Oregon, Estados Unidos, 97701
- Saint Charles Health System
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Clackamas, Oregon, Estados Unidos, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, Estados Unidos, 97015
- Providence Cancer Institute Clackamas Clinic
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Coos Bay, Oregon, Estados Unidos, 97420
- Bay Area Hospital
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Newberg, Oregon, Estados Unidos, 97132
- Providence Newberg Medical Center
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Portland, Oregon, Estados Unidos, 97213
- Providence Portland Medical Center
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Portland, Oregon, Estados Unidos, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Chadds Ford, Pennsylvania, Estados Unidos, 19317
- Christiana Care Health System-Concord Health Center
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Estados Unidos, 57105
- Avera Cancer Institute
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University/Ingram Cancer Center
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Nashville, Tennessee, Estados Unidos, 37204
- Vanderbilt Breast Center at One Hundred Oaks
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Texas
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Bryan, Texas, Estados Unidos, 77802
- Saint Joseph Regional Cancer Center
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Vermont
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Saint Johnsbury, Vermont, Estados Unidos, 05819
- Dartmouth Cancer Center - North
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Washington
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Aberdeen, Washington, Estados Unidos, 98520
- Providence Regional Cancer System-Aberdeen
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Bellevue, Washington, Estados Unidos, 98004
- Overlake Medical Center
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Bellingham, Washington, Estados Unidos, 98225
- PeaceHealth Saint Joseph Medical Center
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Burien, Washington, Estados Unidos, 98166
- Saint Anne Hospital
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Centralia, Washington, Estados Unidos, 98531
- Providence Regional Cancer System-Centralia
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Edmonds, Washington, Estados Unidos, 98026
- Swedish Cancer Institute-Edmonds
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Everett, Washington, Estados Unidos, 98201
- Providence Regional Cancer Partnership
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Issaquah, Washington, Estados Unidos, 98029
- Swedish Cancer Institute-Issaquah
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Lacey, Washington, Estados Unidos, 98503
- Providence Regional Cancer System-Lacey
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Longview, Washington, Estados Unidos, 98632
- PeaceHealth Saint John Medical Center
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Renton, Washington, Estados Unidos, 98055
- Valley Medical Center
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Seattle, Washington, Estados Unidos, 98107
- Swedish Medical Center-Ballard Campus
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Seattle, Washington, Estados Unidos, 98122
- Swedish Medical Center-First Hill
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Sedro-Woolley, Washington, Estados Unidos, 98284
- PeaceHealth United General Medical Center
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Silverdale, Washington, Estados Unidos, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
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Vancouver, Washington, Estados Unidos, 98664
- PeaceHealth Southwest Medical Center
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Walla Walla, Washington, Estados Unidos, 99362
- Providence Saint Mary Regional Cancer Center
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Yakima, Washington, Estados Unidos, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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Wisconsin
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Appleton, Wisconsin, Estados Unidos, 54911
- ThedaCare Regional Cancer Center
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New Richmond, Wisconsin, Estados Unidos, 54017
- Cancer Center of Western Wisconsin
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Wyoming
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Sheridan, Wyoming, Estados Unidos, 82801
- Welch Cancer Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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
Otros nombres:
Undergo CT
Otros nombres:
Undergo MRI
Otros nombres:
Given IV
Otros nombres:
Undergo sigmoidoscopy
Otros nombres:
Undergo short-course radiation therapy
Otros nombres:
Undergo TME
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Respuesta patológica completa
Periodo de tiempo: En el momento de la escisión total del mesorrecto
|
En el momento de la escisión total del mesorrecto
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rate of sphincter preservation in low-lying tumors
Periodo de tiempo: Up to 5 years
|
95% confidence interval will be estimated. |
Up to 5 years
|
|
Disease free survival
Periodo de tiempo: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Overall survival
Periodo de tiempo: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Incidence of adverse events
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Kristen K Ciombor, ECOG-ACRIN Cancer Research Group
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de febrero de 2022
Finalización primaria (Estimado)
30 de junio de 2027
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
11 de febrero de 2021
Primero enviado que cumplió con los criterios de control de calidad
11 de febrero de 2021
Publicado por primera vez (Actual)
12 de febrero de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de octubre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de octubre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades intestinales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias colorrectales
- Neoplasias Intestinales
- Enfermedades Rectales
- Neoplasias Rectales
- Aminoácidos, péptidos y proteínas
- Proteínas
- Técnicas de investigación
- Terapéutica
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Procedimientos quirúrgicos, operativo
- Procedimientos quirúrgicos mínimamente invasivos
- Factores biológicos
- Fenómeno físico
- Anticuerpos, monoclonales, humanizados
- Anticuerpos, monoclonal
- Anticuerpos
- Inmunoglobulinas
- Inmunoproteínas
- Proteínas de la sangre
- Globulinas séricas
- Globulinas
- Técnicas de diagnóstico, quirúrgico
- Endoscopia, gastrointestinal
- Endoscopia, sistema digestivo
- Técnicas de diagnóstico, sistema digestivo
- Endoscopia
- Procedimientos quirúrgicos del sistema digestivo
- Técnicas de química, analítica
- Análisis de espectro
- Receptores, superficie celular
- Proteínas de membrana
- Antígenos
- Colonoscopia
- Antígenos, superficie
- Biomarcadores
- Receptores, inmunológico
- Antígenos, diferenciación, linfocito T
- Antígenos, diferenciación
- Proteínas de punto de control inmunes
- Receptores de células T costimulador e inhibidor
- Nivolumab
- Ipilimumab
- Radioterapia
- Radiación
- Espectroscopía de resonancia magnética
- Sigmoidoscopia
- Antígeno CTLA-4
Otros números de identificación del estudio
- NCI-2021-00912
- U10CA180820 (Subvención/contrato del NIH de EE. UU.)
- NCI-2021-00912 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- EA2201 (Otro identificador: CTEP)
- EA2201 (Otro identificador: ECOG-ACRIN Cancer Research Group)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .