Test di nivolumab e ipilimumab con radiazioni a breve corso nel cancro del retto localmente avanzato
21 ottobre 2026 aggiornato da: National Cancer Institute (NCI)
Uno studio di fase II su nivolumab neoadiuvante più ipilimumab e radiazioni a breve corso nell'adenocarcinoma rettale localmente avanzato con 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
31
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Alabama
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Mobile, Alabama, Stati Uniti, 36607
- Mobile Infirmary Medical Center
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Alaska
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Anchorage, Alaska, Stati Uniti, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Stati Uniti, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Stati Uniti, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Stati Uniti, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Stati Uniti, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Stati Uniti, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Stati Uniti, 99508
- Providence Alaska Medical Center
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Arizona
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Phoenix, Arizona, Stati Uniti, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Fort Smith, Arkansas, Stati Uniti, 72903
- Mercy Hospital Fort Smith
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Hot Springs, Arkansas, Stati Uniti, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Arroyo Grande, California, Stati Uniti, 93420
- PCR Oncology
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Burbank, California, Stati Uniti, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Los Angeles, California, Stati Uniti, 90033
- USC / Norris Comprehensive Cancer Center
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Orange, California, Stati Uniti, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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San Luis Obispo, California, Stati Uniti, 93401
- Pacific Central Coast Health Center-San Luis Obispo
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Santa Maria, California, Stati Uniti, 93444
- Mission Hope Medical Oncology - Santa Maria
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Stati Uniti, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Stati Uniti, 80210
- AdventHealth Porter
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Lakewood, Colorado, Stati Uniti, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Stati Uniti, 80122
- AdventHealth Littleton
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Longmont, Colorado, Stati Uniti, 80501
- Longmont United Hospital
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Parker, Colorado, Stati Uniti, 80138
- AdventHealth Parker
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Pueblo, Colorado, Stati Uniti, 81004
- Saint Mary Corwin Medical Center
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Delaware
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Millville, Delaware, Stati Uniti, 19967
- Beebe South Coastal Health Campus
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Newark, Delaware, Stati Uniti, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Stati Uniti, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Stati Uniti, 19971
- Beebe Health Campus
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Florida
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Altamonte Springs, Florida, Stati Uniti, 32701
- AdventHealth Altamonte
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Orlando, Florida, Stati Uniti, 32803
- AdventHealth Orlando
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Idaho
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Boise, Idaho, Stati Uniti, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Stati Uniti, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Stati Uniti, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Stati Uniti, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Stati Uniti, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Stati Uniti, 83642
- Idaho Urologic Institute-Meridian
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Meridian, Idaho, Stati Uniti, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Stati Uniti, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Stati Uniti, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Stati Uniti, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Twin Falls, Idaho, Stati Uniti, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Stati Uniti, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Stati Uniti, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, Stati Uniti, 62902
- Memorial Hospital of Carbondale
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Carterville, Illinois, Stati Uniti, 62918
- SIH Cancer Institute
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Carthage, Illinois, Stati Uniti, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Stati Uniti, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Stati Uniti, 60612
- University of Illinois
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Danville, Illinois, Stati Uniti, 61832
- Carle at The Riverfront
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Decatur, Illinois, Stati Uniti, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Stati Uniti, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Stati Uniti, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Stati Uniti, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Stati Uniti, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Stati Uniti, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Stati Uniti, 61401
- Western Illinois Cancer Treatment Center
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Galesburg, Illinois, Stati Uniti, 61401
- Illinois CancerCare-Galesburg
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Kewanee, Illinois, Stati Uniti, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, Stati Uniti, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Stati Uniti, 61938
- Carle Physician Group-Mattoon/Charleston
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Mount Vernon, Illinois, Stati Uniti, 62864
- SSM Health Good Samaritan
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O'Fallon, Illinois, Stati Uniti, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, Stati Uniti, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Stati Uniti, 61554
- Illinois CancerCare-Pekin
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Pekin, Illinois, Stati Uniti, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, Stati Uniti, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Stati Uniti, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Stati Uniti, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Stati Uniti, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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Peru, Illinois, Stati Uniti, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Stati Uniti, 61354
- Valley Radiation Oncology
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Princeton, Illinois, Stati Uniti, 61356
- Illinois CancerCare-Princeton
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Springfield, Illinois, Stati Uniti, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Stati Uniti, 62702
- Springfield Clinic
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Springfield, Illinois, Stati Uniti, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Stati Uniti, 61801
- Carle Cancer Center
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Washington, Illinois, Stati Uniti, 61571
- Illinois CancerCare - Washington
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Iowa
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Ames, Iowa, Stati Uniti, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Stati Uniti, 50010
- McFarland Clinic - Ames
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Carroll, Iowa, Stati Uniti, 51401
- Saint Anthony Regional Hospital
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Clive, Iowa, Stati Uniti, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Stati Uniti, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Creston, Iowa, Stati Uniti, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Stati Uniti, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Stati Uniti, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Stati Uniti, 50314
- Broadlawns Medical Center
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Des Moines, Iowa, Stati Uniti, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Stati Uniti, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Stati Uniti, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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West Des Moines, Iowa, Stati Uniti, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, Stati Uniti, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Garden City, Kansas, Stati Uniti, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Stati Uniti, 67530
- Central Care Cancer Center - Great Bend
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, Stati Uniti, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
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Louisville, Kentucky, Stati Uniti, 40202
- Jewish Hospital
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Louisville, Kentucky, Stati Uniti, 40245
- UofL Health Medical Center Northeast
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Massachusetts
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Springfield, Massachusetts, Stati Uniti, 01199
- Baystate Medical Center
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Worcester, Massachusetts, Stati Uniti, 01655
- UMass Memorial Medical Center - University Campus
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Minnesota
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Burnsville, Minnesota, Stati Uniti, 55337
- Fairview Ridges Hospital
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Burnsville, Minnesota, Stati Uniti, 55337
- Minnesota Oncology - Burnsville
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Coon Rapids, Minnesota, Stati Uniti, 55433
- Mercy Hospital
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Edina, Minnesota, Stati Uniti, 55435
- Fairview Southdale Hospital
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Fridley, Minnesota, Stati Uniti, 55432
- Unity Hospital
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Maple Grove, Minnesota, Stati Uniti, 55369
- Fairview Clinics and Surgery Center Maple Grove
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Maplewood, Minnesota, Stati Uniti, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, Stati Uniti, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Stati Uniti, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Stati Uniti, 55407
- Abbott-Northwestern Hospital
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Monticello, Minnesota, Stati Uniti, 55362
- Monticello Cancer Center
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Robbinsdale, Minnesota, Stati Uniti, 55422
- North Memorial Medical Health Center
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic in Rochester
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Saint Louis Park, Minnesota, Stati Uniti, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Stati Uniti, 55101
- Regions Hospital
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Saint Paul, Minnesota, Stati Uniti, 55102
- United Hospital
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Shakopee, Minnesota, Stati Uniti, 55379
- Saint Francis Regional Medical Center
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Waconia, Minnesota, Stati Uniti, 55387
- Ridgeview Medical Center
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Willmar, Minnesota, Stati Uniti, 56201
- Rice Memorial Hospital
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Woodbury, Minnesota, Stati Uniti, 55125
- Minnesota Oncology Hematology PA-Woodbury
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Missouri
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Ballwin, Missouri, Stati Uniti, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
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Bolivar, Missouri, Stati Uniti, 65613
- Central Care Cancer Center - Bolivar
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Cape Girardeau, Missouri, Stati Uniti, 63703
- Saint Francis Medical Center
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Cape Girardeau, Missouri, Stati Uniti, 63703
- Mercy Cancer Center - Cape Girardeau
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Farmington, Missouri, Stati Uniti, 63640
- Parkland Health Center - Farmington
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Jefferson City, Missouri, Stati Uniti, 65109
- MU Health Care Goldschmidt Cancer Center
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Joplin, Missouri, Stati Uniti, 64804
- Freeman Health System
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Joplin, Missouri, Stati Uniti, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Stati Uniti, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Rolla, Missouri, Stati Uniti, 65401
- Phelps Health Delbert Day Cancer Institute
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Saint Joseph, Missouri, Stati Uniti, 64506
- Heartland Regional Medical Center
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Sainte Genevieve, Missouri, Stati Uniti, 63670
- Sainte Genevieve County Memorial Hospital
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Springfield, Missouri, Stati Uniti, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Stati Uniti, 65804
- Mercy Hospital Springfield
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St Louis, Missouri, Stati Uniti, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Stati Uniti, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Stati Uniti, 63128
- Mercy Hospital South
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Sullivan, Missouri, Stati Uniti, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Billings, Montana, Stati Uniti, 59101
- Billings Clinic Cancer Center
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Bozeman, Montana, Stati Uniti, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Stati Uniti, 59405
- Great Falls Clinic
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Great Falls, Montana, Stati Uniti, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, Stati Uniti, 59901
- Logan Health Medical Center
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Missoula, Montana, Stati Uniti, 59802
- Saint Patrick Hospital - Community Hospital
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Missoula, Montana, Stati Uniti, 59804
- Community Medical Center
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Nebraska
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Grand Island, Nebraska, Stati Uniti, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
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Kearney, Nebraska, Stati Uniti, 68847
- CHI Health Good Samaritan
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Omaha, Nebraska, Stati Uniti, 68124
- Alegent Health Bergan Mercy Medical Center
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Omaha, Nebraska, Stati Uniti, 68122
- Alegent Health Immanuel Medical Center
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Omaha, Nebraska, Stati Uniti, 68130
- Alegent Health Lakeside Hospital
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Nevada
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Henderson, Nevada, Stati Uniti, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
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Henderson, Nevada, Stati Uniti, 89074
- Oncology Las Vegas - Henderson
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Las Vegas, Nevada, Stati Uniti, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, Stati Uniti, 89106
- Radiation Oncology Centers of Nevada Central
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Las Vegas, Nevada, Stati Uniti, 89119
- Radiation Oncology Centers of Nevada Southeast
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Las Vegas, Nevada, Stati Uniti, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
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Las Vegas, Nevada, Stati Uniti, 89128
- OptumCare Cancer Care at MountainView
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Las Vegas, Nevada, Stati Uniti, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
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Las Vegas, Nevada, Stati Uniti, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
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Las Vegas, Nevada, Stati Uniti, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
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Las Vegas, Nevada, Stati Uniti, 89148
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Stati Uniti, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
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Las Vegas, Nevada, Stati Uniti, 89183
- OptumCare Cancer Care at Fort Apache
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Reno, Nevada, Stati Uniti, 89502
- Renown Regional Medical Center
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Reno, Nevada, Stati Uniti, 89503
- Saint Mary's Regional Medical Center
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Reno, Nevada, Stati Uniti, 89509
- Radiation Oncology Associates
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New Hampshire
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Concord, New Hampshire, Stati Uniti, 03301
- New Hampshire Oncology Hematology PA-Concord
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Lebanon, New Hampshire, Stati Uniti, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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Manchester, New Hampshire, Stati Uniti, 03103
- Solinsky Center for Cancer Care
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New York
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Lake Success, New York, Stati Uniti, 11042
- Northwell Health/Center for Advanced Medicine
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Middletown, New York, Stati Uniti, 10940
- Garnet Health Medical Center
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Mount Kisco, New York, Stati Uniti, 10549
- Northern Westchester Hospital
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New York, New York, Stati Uniti, 10075
- Lenox Hill Hospital
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New York, New York, Stati Uniti, 10065
- Manhattan Eye Ear and Throat Hospital
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45220
- Good Samaritan Hospital - Cincinnati
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Cincinnati, Ohio, Stati Uniti, 45242
- Bethesda North Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Stati Uniti, 73120
- Mercy Hospital Oklahoma City
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Oregon
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Bend, Oregon, Stati Uniti, 97701
- Saint Charles Health System
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Clackamas, Oregon, Stati Uniti, 97015
- Clackamas Radiation Oncology Center
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Clackamas, Oregon, Stati Uniti, 97015
- Providence Cancer Institute Clackamas Clinic
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Coos Bay, Oregon, Stati Uniti, 97420
- Bay Area Hospital
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Newberg, Oregon, Stati Uniti, 97132
- Providence Newberg Medical Center
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Portland, Oregon, Stati Uniti, 97213
- Providence Portland Medical Center
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Portland, Oregon, Stati Uniti, 97225
- Providence Saint Vincent Medical Center
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Pennsylvania
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Chadds Ford, Pennsylvania, Stati Uniti, 19317
- Christiana Care Health System-Concord Health Center
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South Dakota
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Rapid City, South Dakota, Stati Uniti, 57701
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Stati Uniti, 57105
- Avera Cancer Institute
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37232
- Vanderbilt University/Ingram Cancer Center
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Nashville, Tennessee, Stati Uniti, 37204
- Vanderbilt Breast Center at One Hundred Oaks
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Texas
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Bryan, Texas, Stati Uniti, 77802
- Saint Joseph Regional Cancer Center
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Vermont
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Saint Johnsbury, Vermont, Stati Uniti, 05819
- Dartmouth Cancer Center - North
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Washington
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Aberdeen, Washington, Stati Uniti, 98520
- Providence Regional Cancer System-Aberdeen
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Bellevue, Washington, Stati Uniti, 98004
- Overlake Medical Center
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Bellingham, Washington, Stati Uniti, 98225
- PeaceHealth Saint Joseph Medical Center
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Burien, Washington, Stati Uniti, 98166
- Saint Anne Hospital
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Centralia, Washington, Stati Uniti, 98531
- Providence Regional Cancer System-Centralia
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Edmonds, Washington, Stati Uniti, 98026
- Swedish Cancer Institute-Edmonds
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Everett, Washington, Stati Uniti, 98201
- Providence Regional Cancer Partnership
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Issaquah, Washington, Stati Uniti, 98029
- Swedish Cancer Institute-Issaquah
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Lacey, Washington, Stati Uniti, 98503
- Providence Regional Cancer System-Lacey
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Longview, Washington, Stati Uniti, 98632
- PeaceHealth Saint John Medical Center
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Renton, Washington, Stati Uniti, 98055
- Valley Medical Center
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Seattle, Washington, Stati Uniti, 98107
- Swedish Medical Center-Ballard Campus
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Seattle, Washington, Stati Uniti, 98122
- Swedish Medical Center-First Hill
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Sedro-Woolley, Washington, Stati Uniti, 98284
- PeaceHealth United General Medical Center
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Silverdale, Washington, Stati Uniti, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
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Vancouver, Washington, Stati Uniti, 98664
- PeaceHealth Southwest Medical Center
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Walla Walla, Washington, Stati Uniti, 99362
- Providence Saint Mary Regional Cancer Center
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Yakima, Washington, Stati Uniti, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
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Wisconsin
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Appleton, Wisconsin, Stati Uniti, 54911
- ThedaCare Regional Cancer Center
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New Richmond, Wisconsin, Stati Uniti, 54017
- Cancer Center of Western Wisconsin
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Wyoming
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Sheridan, Wyoming, Stati Uniti, 82801
- Welch Cancer Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
Undergo CT
Altri nomi:
Undergo MRI
Altri nomi:
Given IV
Altri nomi:
Undergo sigmoidoscopy
Altri nomi:
Undergo short-course radiation therapy
Altri nomi:
Undergo TME
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Risposta completa patologica
Lasso di tempo: Al momento dell'escissione totale del mesoretto
|
Al momento dell'escissione totale del mesoretto
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Rate of sphincter preservation in low-lying tumors
Lasso di tempo: Up to 5 years
|
95% confidence interval will be estimated. |
Up to 5 years
|
|
Disease free survival
Lasso di tempo: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Overall survival
Lasso di tempo: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Incidence of adverse events
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Kristen K Ciombor, ECOG-ACRIN Cancer Research Group
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
8 febbraio 2022
Completamento primario (Stimato)
30 giugno 2027
Completamento dello studio (Stimato)
30 giugno 2027
Date di iscrizione allo studio
Primo inviato
11 febbraio 2021
Primo inviato che soddisfa i criteri di controllo qualità
11 febbraio 2021
Primo Inserito (Effettivo)
12 febbraio 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 ottobre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 ottobre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Neoplasie
- Malattie intestinali
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Neoplasie colorettali
- Neoplasie intestinali
- Malattie del retto
- Neoplasie Rettali
- Aminoacidi, peptidi e proteine
- Proteine
- Tecniche investigative
- Terapie
- Tecniche e procedure diagnostiche
- Diagnosi
- Procedure chirurgiche, operative
- Procedure chirurgiche minimamente invasive
- Fattori biologici
- Fenomeni fisici
- Anticorpi, monoclonali, umanizzati
- Anticorpi, monoclonali
- Anticorpi
- Immunoglobuline
- Immunoproteine
- Proteine del sangue
- Globuline sieriche
- Globuline
- Tecniche diagnostiche, chirurgiche
- Endoscopia, gastrointestinale
- Endoscopia, sistema digestivo
- Tecniche diagnostiche, sistema digestivo
- Endoscopia
- Procedure chirurgiche del sistema digestivo
- Tecniche di chimica, analitiche
- Analisi dello spettro
- Recettori, superficie cellulare
- Proteine della membrana
- Antigeni
- Colonscopia
- Antigeni, superficie
- Biomarcatori
- Recettori, immunologici
- Antigeni, differenziazione, T-linfocita
- Antigeni, differenziazione
- Proteine del checkpoint immunitario
- Recettori costimolativi e inibitori delle cellule T.
- Nivolumab
- Ipilimumab
- Radioterapia
- Radiazione
- Spettroscopia di risonanza magnetica
- Sigmoidoscopia
- Antigene CTLA-4
Altri numeri di identificazione dello studio
- NCI-2021-00912
- U10CA180820 (Sovvenzione/contratto NIH degli Stati Uniti)
- NCI-2021-00912 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
- EA2201 (Altro identificatore: CTEP)
- EA2201 (Altro identificatore: ECOG-ACRIN Cancer Research Group)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .