Tester Nivolumab og Ipilimumab med kortvarig stråling ved lokalt avansert rektalkreft
21. oktober 2026 oppdatert av: National Cancer Institute (NCI)
En fase II-studie av Neoadjuvant Nivolumab Plus Ipilimumab og kortkursstråling ved MSI-H/dMMR lokalt avansert rektal adenokarsinom
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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Detaljert beskrivelse
PRIMARY OBJECTIVE:
I. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve the pathologic complete response rate (pCR) in microsatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR) locally advanced rectal adenocarcinoma at total mesorectal excision (TME).
SECONDARY OBJECTIVES:
I. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve the rate of sphincter preservation in low-lying tumors.
II. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve 5-year disease-free survival (DFS).
III. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve overall survival (OS).
IV. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will have acceptable safety/toxicity.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for 2 cycles. Starting at least 2 weeks but no longer than 6 weeks after completion of cycle 2 of nivolumab and ipilimumab, patients undergo short-course radiation therapy of 5 fractions daily for 1 week. Patients then continue to receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 28 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 8-12 weeks after completion of 4th cycle of nivolumab and ipilimumab, patients undergo TME. Patients also undergo magnetic resonance imaging (MRI) and computed tomography (CT) prior to TME and during follow up, and undergo sigmoidoscopy prior to TME.
After completion of study treatment, patients are followed up for 5 years.
Studietype
Intervensjonell
Registrering (Antatt)
31
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Alabama
-
Mobile, Alabama, Forente stater, 36607
- Mobile Infirmary Medical Center
-
-
Alaska
-
Anchorage, Alaska, Forente stater, 98508
- Anchorage Associates in Radiation Medicine
-
Anchorage, Alaska, Forente stater, 99508
- Alaska Breast Care and Surgery LLC
-
Anchorage, Alaska, Forente stater, 99508
- Alaska Oncology and Hematology LLC
-
Anchorage, Alaska, Forente stater, 99508
- Alaska Women's Cancer Care
-
Anchorage, Alaska, Forente stater, 99508
- Anchorage Oncology Centre
-
Anchorage, Alaska, Forente stater, 99508
- Katmai Oncology Group
-
Anchorage, Alaska, Forente stater, 99508
- Providence Alaska Medical Center
-
-
Arizona
-
Phoenix, Arizona, Forente stater, 85004
- Cancer Center at Saint Joseph's
-
-
Arkansas
-
Fort Smith, Arkansas, Forente stater, 72903
- Mercy Hospital Fort Smith
-
Hot Springs, Arkansas, Forente stater, 71913
- CHI Saint Vincent Cancer Center Hot Springs
-
-
California
-
Arroyo Grande, California, Forente stater, 93420
- PCR Oncology
-
Burbank, California, Forente stater, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
-
Los Angeles, California, Forente stater, 90033
- USC / Norris Comprehensive Cancer Center
-
Orange, California, Forente stater, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
-
San Luis Obispo, California, Forente stater, 93401
- Pacific Central Coast Health Center-San Luis Obispo
-
Santa Maria, California, Forente stater, 93444
- Mission Hope Medical Oncology - Santa Maria
-
-
Colorado
-
Colorado Springs, Colorado, Forente stater, 80907
- Penrose-Saint Francis Healthcare
-
Colorado Springs, Colorado, Forente stater, 80907
- Rocky Mountain Cancer Centers-Penrose
-
Denver, Colorado, Forente stater, 80210
- AdventHealth Porter
-
Lakewood, Colorado, Forente stater, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
-
Littleton, Colorado, Forente stater, 80122
- AdventHealth Littleton
-
Longmont, Colorado, Forente stater, 80501
- Longmont United Hospital
-
Parker, Colorado, Forente stater, 80138
- AdventHealth Parker
-
Pueblo, Colorado, Forente stater, 81004
- Saint Mary Corwin Medical Center
-
-
Delaware
-
Millville, Delaware, Forente stater, 19967
- Beebe South Coastal Health Campus
-
Newark, Delaware, Forente stater, 19713
- Helen F Graham Cancer Center
-
Newark, Delaware, Forente stater, 19713
- Medical Oncology Hematology Consultants PA
-
Rehoboth Beach, Delaware, Forente stater, 19971
- Beebe Health Campus
-
-
Florida
-
Altamonte Springs, Florida, Forente stater, 32701
- AdventHealth Altamonte
-
Orlando, Florida, Forente stater, 32803
- AdventHealth Orlando
-
-
Idaho
-
Boise, Idaho, Forente stater, 83706
- Saint Alphonsus Cancer Care Center-Boise
-
Boise, Idaho, Forente stater, 83712
- Saint Luke's Cancer Institute - Boise
-
Caldwell, Idaho, Forente stater, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
-
Coeur d'Alene, Idaho, Forente stater, 83814
- Kootenai Health - Coeur d'Alene
-
Fruitland, Idaho, Forente stater, 83619
- Saint Luke's Cancer Institute - Fruitland
-
Meridian, Idaho, Forente stater, 83642
- Idaho Urologic Institute-Meridian
-
Meridian, Idaho, Forente stater, 83642
- Saint Luke's Cancer Institute - Meridian
-
Nampa, Idaho, Forente stater, 83687
- Saint Alphonsus Cancer Care Center-Nampa
-
Nampa, Idaho, Forente stater, 83687
- Saint Luke's Cancer Institute - Nampa
-
Post Falls, Idaho, Forente stater, 83854
- Kootenai Clinic Cancer Services - Post Falls
-
Twin Falls, Idaho, Forente stater, 83301
- Saint Luke's Cancer Institute - Twin Falls
-
-
Illinois
-
Bloomington, Illinois, Forente stater, 61704
- Illinois CancerCare-Bloomington
-
Canton, Illinois, Forente stater, 61520
- Illinois CancerCare-Canton
-
Carbondale, Illinois, Forente stater, 62902
- Memorial Hospital of Carbondale
-
Carterville, Illinois, Forente stater, 62918
- SIH Cancer Institute
-
Carthage, Illinois, Forente stater, 62321
- Illinois CancerCare-Carthage
-
Centralia, Illinois, Forente stater, 62801
- Centralia Oncology Clinic
-
Chicago, Illinois, Forente stater, 60612
- University of Illinois
-
Danville, Illinois, Forente stater, 61832
- Carle at The Riverfront
-
Decatur, Illinois, Forente stater, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, Forente stater, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon, Illinois, Forente stater, 61021
- Illinois CancerCare-Dixon
-
Effingham, Illinois, Forente stater, 62401
- Crossroads Cancer Center
-
Effingham, Illinois, Forente stater, 62401
- Carle Physician Group-Effingham
-
Eureka, Illinois, Forente stater, 61530
- Illinois CancerCare-Eureka
-
Galesburg, Illinois, Forente stater, 61401
- Western Illinois Cancer Treatment Center
-
Galesburg, Illinois, Forente stater, 61401
- Illinois CancerCare-Galesburg
-
Kewanee, Illinois, Forente stater, 61443
- Illinois CancerCare-Kewanee Clinic
-
Macomb, Illinois, Forente stater, 61455
- Illinois CancerCare-Macomb
-
Mattoon, Illinois, Forente stater, 61938
- Carle Physician Group-Mattoon/Charleston
-
Mount Vernon, Illinois, Forente stater, 62864
- SSM Health Good Samaritan
-
O'Fallon, Illinois, Forente stater, 62269
- Cancer Care Center of O'Fallon
-
Ottawa, Illinois, Forente stater, 61350
- Illinois CancerCare-Ottawa Clinic
-
Pekin, Illinois, Forente stater, 61554
- Illinois CancerCare-Pekin
-
Pekin, Illinois, Forente stater, 61554
- OSF Saint Francis Radiation Oncology at Pekin
-
Peoria, Illinois, Forente stater, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Forente stater, 61637
- OSF Saint Francis Medical Center
-
Peoria, Illinois, Forente stater, 61615
- Illinois CancerCare-Peoria
-
Peoria, Illinois, Forente stater, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
-
Peru, Illinois, Forente stater, 61354
- Illinois CancerCare-Peru
-
Peru, Illinois, Forente stater, 61354
- Valley Radiation Oncology
-
Princeton, Illinois, Forente stater, 61356
- Illinois CancerCare-Princeton
-
Springfield, Illinois, Forente stater, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, Forente stater, 62702
- Springfield Clinic
-
Springfield, Illinois, Forente stater, 62781
- Springfield Memorial Hospital
-
Urbana, Illinois, Forente stater, 61801
- Carle Cancer Center
-
Washington, Illinois, Forente stater, 61571
- Illinois CancerCare - Washington
-
-
Iowa
-
Ames, Iowa, Forente stater, 50010
- Mary Greeley Medical Center
-
Ames, Iowa, Forente stater, 50010
- McFarland Clinic - Ames
-
Carroll, Iowa, Forente stater, 51401
- Saint Anthony Regional Hospital
-
Clive, Iowa, Forente stater, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, Forente stater, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Creston, Iowa, Forente stater, 50801
- Greater Regional Medical Center
-
Des Moines, Iowa, Forente stater, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Forente stater, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Forente stater, 50314
- Broadlawns Medical Center
-
Des Moines, Iowa, Forente stater, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, Forente stater, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Des Moines, Iowa, Forente stater, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
West Des Moines, Iowa, Forente stater, 50266-7700
- Methodist West Hospital
-
West Des Moines, Iowa, Forente stater, 50266
- Mercy Medical Center-West Lakes
-
-
Kansas
-
Garden City, Kansas, Forente stater, 67846
- Central Care Cancer Center - Garden City
-
Great Bend, Kansas, Forente stater, 67530
- Central Care Cancer Center - Great Bend
-
-
Kentucky
-
Lexington, Kentucky, Forente stater, 40504
- Saint Joseph Radiation Oncology Resource Center
-
Lexington, Kentucky, Forente stater, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
-
Louisville, Kentucky, Forente stater, 40202
- Jewish Hospital
-
Louisville, Kentucky, Forente stater, 40245
- UofL Health Medical Center Northeast
-
-
Massachusetts
-
Springfield, Massachusetts, Forente stater, 01199
- Baystate Medical Center
-
Worcester, Massachusetts, Forente stater, 01655
- UMass Memorial Medical Center - University Campus
-
-
Minnesota
-
Burnsville, Minnesota, Forente stater, 55337
- Fairview Ridges Hospital
-
Burnsville, Minnesota, Forente stater, 55337
- Minnesota Oncology - Burnsville
-
Coon Rapids, Minnesota, Forente stater, 55433
- Mercy Hospital
-
Edina, Minnesota, Forente stater, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, Forente stater, 55432
- Unity Hospital
-
Maple Grove, Minnesota, Forente stater, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, Forente stater, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Forente stater, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Forente stater, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Forente stater, 55407
- Abbott-Northwestern Hospital
-
Monticello, Minnesota, Forente stater, 55362
- Monticello Cancer Center
-
Robbinsdale, Minnesota, Forente stater, 55422
- North Memorial Medical Health Center
-
Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic in Rochester
-
Saint Louis Park, Minnesota, Forente stater, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, Forente stater, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Forente stater, 55102
- United Hospital
-
Shakopee, Minnesota, Forente stater, 55379
- Saint Francis Regional Medical Center
-
Waconia, Minnesota, Forente stater, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Forente stater, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Forente stater, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
-
Missouri
-
Ballwin, Missouri, Forente stater, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
-
Bolivar, Missouri, Forente stater, 65613
- Central Care Cancer Center - Bolivar
-
Cape Girardeau, Missouri, Forente stater, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, Forente stater, 63703
- Mercy Cancer Center - Cape Girardeau
-
Farmington, Missouri, Forente stater, 63640
- Parkland Health Center - Farmington
-
Jefferson City, Missouri, Forente stater, 65109
- MU Health Care Goldschmidt Cancer Center
-
Joplin, Missouri, Forente stater, 64804
- Freeman Health System
-
Joplin, Missouri, Forente stater, 64804
- Mercy Hospital Joplin
-
Rolla, Missouri, Forente stater, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, Forente stater, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, Forente stater, 64506
- Heartland Regional Medical Center
-
Sainte Genevieve, Missouri, Forente stater, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, Forente stater, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Forente stater, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Forente stater, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Forente stater, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Forente stater, 63128
- Mercy Hospital South
-
Sullivan, Missouri, Forente stater, 63080
- Missouri Baptist Sullivan Hospital
-
-
Montana
-
Billings, Montana, Forente stater, 59101
- Billings Clinic Cancer Center
-
Bozeman, Montana, Forente stater, 59715
- Bozeman Health Deaconess Hospital
-
Great Falls, Montana, Forente stater, 59405
- Great Falls Clinic
-
Great Falls, Montana, Forente stater, 59405
- Benefis Sletten Cancer Institute
-
Kalispell, Montana, Forente stater, 59901
- Logan Health Medical Center
-
Missoula, Montana, Forente stater, 59802
- Saint Patrick Hospital - Community Hospital
-
Missoula, Montana, Forente stater, 59804
- Community Medical Center
-
-
Nebraska
-
Grand Island, Nebraska, Forente stater, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, Forente stater, 68847
- CHI Health Good Samaritan
-
Omaha, Nebraska, Forente stater, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Forente stater, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Forente stater, 68130
- Alegent Health Lakeside Hospital
-
-
Nevada
-
Henderson, Nevada, Forente stater, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Forente stater, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Forente stater, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, Forente stater, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Forente stater, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Forente stater, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Forente stater, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, Forente stater, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, Forente stater, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, Forente stater, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Forente stater, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Forente stater, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Forente stater, 89183
- OptumCare Cancer Care at Fort Apache
-
Reno, Nevada, Forente stater, 89502
- Renown Regional Medical Center
-
Reno, Nevada, Forente stater, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, Forente stater, 89509
- Radiation Oncology Associates
-
-
New Hampshire
-
Concord, New Hampshire, Forente stater, 03301
- New Hampshire Oncology Hematology PA-Concord
-
Lebanon, New Hampshire, Forente stater, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
Manchester, New Hampshire, Forente stater, 03103
- Solinsky Center for Cancer Care
-
-
New York
-
Lake Success, New York, Forente stater, 11042
- Northwell Health/Center for Advanced Medicine
-
Middletown, New York, Forente stater, 10940
- Garnet Health Medical Center
-
Mount Kisco, New York, Forente stater, 10549
- Northern Westchester Hospital
-
New York, New York, Forente stater, 10075
- Lenox Hill Hospital
-
New York, New York, Forente stater, 10065
- Manhattan Eye Ear and Throat Hospital
-
-
Ohio
-
Cincinnati, Ohio, Forente stater, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Forente stater, 45242
- Bethesda North Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Forente stater, 73120
- Mercy Hospital Oklahoma City
-
-
Oregon
-
Bend, Oregon, Forente stater, 97701
- Saint Charles Health System
-
Clackamas, Oregon, Forente stater, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, Forente stater, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, Forente stater, 97420
- Bay Area Hospital
-
Newberg, Oregon, Forente stater, 97132
- Providence Newberg Medical Center
-
Portland, Oregon, Forente stater, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Forente stater, 97225
- Providence Saint Vincent Medical Center
-
-
Pennsylvania
-
Chadds Ford, Pennsylvania, Forente stater, 19317
- Christiana Care Health System-Concord Health Center
-
-
South Dakota
-
Rapid City, South Dakota, Forente stater, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Forente stater, 57105
- Avera Cancer Institute
-
-
Tennessee
-
Nashville, Tennessee, Forente stater, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, Forente stater, 37204
- Vanderbilt Breast Center at One Hundred Oaks
-
-
Texas
-
Bryan, Texas, Forente stater, 77802
- Saint Joseph Regional Cancer Center
-
-
Vermont
-
Saint Johnsbury, Vermont, Forente stater, 05819
- Dartmouth Cancer Center - North
-
-
Washington
-
Aberdeen, Washington, Forente stater, 98520
- Providence Regional Cancer System-Aberdeen
-
Bellevue, Washington, Forente stater, 98004
- Overlake Medical Center
-
Bellingham, Washington, Forente stater, 98225
- PeaceHealth Saint Joseph Medical Center
-
Burien, Washington, Forente stater, 98166
- Saint Anne Hospital
-
Centralia, Washington, Forente stater, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, Forente stater, 98026
- Swedish Cancer Institute-Edmonds
-
Everett, Washington, Forente stater, 98201
- Providence Regional Cancer Partnership
-
Issaquah, Washington, Forente stater, 98029
- Swedish Cancer Institute-Issaquah
-
Lacey, Washington, Forente stater, 98503
- Providence Regional Cancer System-Lacey
-
Longview, Washington, Forente stater, 98632
- PeaceHealth Saint John Medical Center
-
Renton, Washington, Forente stater, 98055
- Valley Medical Center
-
Seattle, Washington, Forente stater, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, Forente stater, 98122
- Swedish Medical Center-First Hill
-
Sedro-Woolley, Washington, Forente stater, 98284
- PeaceHealth United General Medical Center
-
Silverdale, Washington, Forente stater, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
-
Vancouver, Washington, Forente stater, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, Forente stater, 99362
- Providence Saint Mary Regional Cancer Center
-
Yakima, Washington, Forente stater, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
-
Wisconsin
-
Appleton, Wisconsin, Forente stater, 54911
- ThedaCare Regional Cancer Center
-
New Richmond, Wisconsin, Forente stater, 54017
- Cancer Center of Western Wisconsin
-
-
Wyoming
-
Sheridan, Wyoming, Forente stater, 82801
- Welch Cancer Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
Andre navn:
Undergo CT
Andre navn:
Undergo MRI
Andre navn:
Given IV
Andre navn:
Undergo sigmoidoscopy
Andre navn:
Undergo short-course radiation therapy
Andre navn:
Undergo TME
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Patologisk fullstendig respons
Tidsramme: På tidspunktet for total mesorektal eksisjon
|
På tidspunktet for total mesorektal eksisjon
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of sphincter preservation in low-lying tumors
Tidsramme: Up to 5 years
|
95% confidence interval will be estimated. |
Up to 5 years
|
|
Disease free survival
Tidsramme: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Overall survival
Tidsramme: Up to 5 years
|
Kaplan-Meier method will be used. |
Up to 5 years
|
|
Incidence of adverse events
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Kristen K Ciombor, ECOG-ACRIN Cancer Research Group
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. februar 2022
Primær fullføring (Antatt)
30. juni 2027
Studiet fullført (Antatt)
30. juni 2027
Datoer for studieregistrering
Først innsendt
11. februar 2021
Først innsendt som oppfylte QC-kriteriene
11. februar 2021
Først lagt ut (Faktiske)
12. februar 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. oktober 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Tarmsykdommer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Kolorektale neoplasmer
- Intestinale neoplasmer
- Rektale sykdommer
- Rektale neoplasmer
- Aminosyrer, peptider og proteiner
- Proteiner
- Undersøkelsesteknikker
- Terapeutikk
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Kirurgiske prosedyrer, operativ
- Minimalt invasive kirurgiske inngrep
- Biologiske faktorer
- Fysiske fenomener
- Antistoffer, monoklonalt, humanisert
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Diagnostiske teknikker, kirurgisk
- Endoskopi, gastrointestinal
- Endoskopi, fordøyelsessystem
- Diagnostiske teknikker, fordøyelsessystem
- Endoskopi
- Fordøyelsessystem kirurgiske inngrep
- Kjemisteknikker, analytisk
- Spektrumanalyse
- Reseptorer, celleoverflate
- Membranproteiner
- Antigener
- Koloskopi
- Antigener, overflate
- Biomarkører
- Reseptorer, immunologisk
- Antigener, differensiering, T-lymfocytt
- Antigener, differensiering
- Immunsjekkpunktproteiner
- Kostimulerende og hemmende T-celle reseptorer
- Nivolumab
- Ipilimumab
- Strålebehandling
- Stråling
- Magnetisk resonansspektroskopi
- Sigmoidoskopi
- CTLA-4 antigen
Andre studie-ID-numre
- NCI-2021-00912
- U10CA180820 (U.S. NIH-stipend/kontrakt)
- NCI-2021-00912 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- EA2201 (Annen identifikator: CTEP)
- EA2201 (Annen identifikator: ECOG-ACRIN Cancer Research Group)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .