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Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT04751370
Collaborator
(none)
31
Enrollment
196
Locations
1
Arm
16.6
Anticipated Duration (Months)
0.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 other places in the body (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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Ipilimumab
  • Biological: Nivolumab
  • Radiation: Radiation Therapy
  • Procedure: Total Mesorectal Excision
 Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:

  1. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve the rate of sphincter preservation in low-lying tumors.

  2. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve 5-year disease-free survival (DFS).

  3. To demonstrate that neoadjuvant nivolumab and ipilimumab in combination with short-course radiation will improve overall survival (OS).

  4. 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 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 total mesorectal excision.

After completion of study treatment, patients are followed up for 5 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
31 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Neoadjuvant Nivolumab Plus Ipilimumab and Short-Course Radiation in MSI-H/dMMR Locally Advanced Rectal Adenocarcinoma
Actual Study Start Date :
May 13, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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 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 total mesorectal excision.

Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • Ipilimumab Biosimilar CS1002
  • MDX-010
  • MDX-CTLA4
  • Yervoy

    • Biological: Nivolumab
    Given IV
    Other Names:
  • BMS-936558
  • CMAB819
  • MDX-1106
  • NIVO
  • Nivolumab Biosimilar CMAB819
  • ONO-4538
  • Opdivo

    • Radiation: Radiation Therapy
    Undergo short-course radiation therapy
    Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation

    • Procedure: Total Mesorectal Excision
    Undergo TME
    Other Names:
  • TME

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pathological complete response [At the time of total mesorectal excision]

    Secondary Outcome Measures

    1. Rate of sphincter preservation in low-lying tumors [Up to 5 years]

      95% confidence interval will be estimated.

    2. Disease free survival [Up to 5 years]

      Kaplan-Meier method will be used.

    3. Overall survival [Up to 5 years]

      Kaplan-Meier method will be used.

    4. Incidence of adverse events [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 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 agree to not receive live vaccines while on this study

    • 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

    Exclusion Criteria:

    • Patient must not have previously received chemotherapy or immunotherapy for rectal cancer

    • Patient must not have previously received radiotherapy to the pelvis

    • 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 computed tomography (CT) scan

    • Patient must not have a serious active infection requiring IV antibiotics at time of registration

    • 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)

    • 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 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anchorage Associates in Radiation Medicine Anchorage Alaska United States 98508
    2 Alaska Breast Care and Surgery LLC Anchorage Alaska United States 99508
    3 Alaska Oncology and Hematology LLC Anchorage Alaska United States 99508
    4 Alaska Women's Cancer Care Anchorage Alaska United States 99508
    5 Anchorage Oncology Centre Anchorage Alaska United States 99508
    6 Katmai Oncology Group Anchorage Alaska United States 99508
    7 Providence Alaska Medical Center Anchorage Alaska United States 99508
    8 Cancer Center at Saint Joseph's Phoenix Arizona United States 85004
    9 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
    10 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
    11 PCR Oncology Arroyo Grande California United States 93420
    12 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    13 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    14 Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California United States 93401
    15 Mission Hope Medical Oncology - Santa Maria Santa Maria California United States 93444
    16 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    17 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    18 Porter Adventist Hospital Denver Colorado United States 80210
    19 Saint Anthony Hospital Lakewood Colorado United States 80228
    20 Littleton Adventist Hospital Littleton Colorado United States 80122
    21 Longmont United Hospital Longmont Colorado United States 80501
    22 Parker Adventist Hospital Parker Colorado United States 80138
    23 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    24 Beebe South Coastal Health Campus Frankford Delaware United States 19945
    25 Helen F Graham Cancer Center Newark Delaware United States 19713
    26 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    27 Beebe Health Campus Rehoboth Beach Delaware United States 19971
    28 AdventHealth Altamonte Altamonte Springs Florida United States 32701
    29 AdventHealth Orlando Orlando Florida United States 32803
    30 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    31 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    32 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    33 Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho United States 83814
    34 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    35 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
    36 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    37 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    38 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    39 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
    40 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    41 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    42 Illinois CancerCare-Canton Canton Illinois United States 61520
    43 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
    44 SIH Cancer Institute Carterville Illinois United States 62918
    45 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    46 Centralia Oncology Clinic Centralia Illinois United States 62801
    47 University of Illinois Chicago Illinois United States 60612
    48 Carle on Vermilion Danville Illinois United States 61832
    49 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    50 Decatur Memorial Hospital Decatur Illinois United States 62526
    51 Illinois CancerCare-Dixon Dixon Illinois United States 61021
    52 Carle Physician Group-Effingham Effingham Illinois United States 62401
    53 Crossroads Cancer Center Effingham Illinois United States 62401
    54 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    55 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    56 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    57 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    58 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    59 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    60 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    61 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    62 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    63 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    64 OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois United States 61554
    65 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    66 OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois United States 61615
    67 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    68 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    69 Illinois CancerCare-Peru Peru Illinois United States 61354
    70 Valley Radiation Oncology Peru Illinois United States 61354
    71 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    72 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    73 Springfield Clinic Springfield Illinois United States 62702
    74 Memorial Medical Center Springfield Illinois United States 62781
    75 Carle Cancer Center Urbana Illinois United States 61801
    76 Illinois CancerCare - Washington Washington Illinois United States 61571
    77 Mary Greeley Medical Center Ames Iowa United States 50010
    78 McFarland Clinic PC - Ames Ames Iowa United States 50010
    79 Saint Anthony Regional Hospital Carroll Iowa United States 51401
    80 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    81 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    82 Greater Regional Medical Center Creston Iowa United States 50801
    83 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    84 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    85 Broadlawns Medical Center Des Moines Iowa United States 50314
    86 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    87 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    88 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    89 Methodist West Hospital West Des Moines Iowa United States 50266-7700
    90 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    91 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
    92 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
    93 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
    94 Saint Joseph Hospital East Lexington Kentucky United States 40509
    95 Jewish Hospital Louisville Kentucky United States 40202
    96 UofL Health Medical Center Northeast Louisville Kentucky United States 40245
    97 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    98 Mercy Hospital Coon Rapids Minnesota United States 55433
    99 Fairview Southdale Hospital Edina Minnesota United States 55435
    100 Unity Hospital Fridley Minnesota United States 55432
    101 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
    102 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    103 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    104 Monticello Cancer Center Monticello Minnesota United States 55362
    105 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    106 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    107 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    108 Regions Hospital Saint Paul Minnesota United States 55101
    109 Rice Memorial Hospital Willmar Minnesota United States 56201
    110 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    111 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
    112 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    113 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    114 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    115 Parkland Health Center - Farmington Farmington Missouri United States 63640
    116 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    117 Freeman Health System Joplin Missouri United States 64804
    118 Mercy Hospital Joplin Joplin Missouri United States 64804
    119 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    120 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    121 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    122 Mercy Hospital South Saint Louis Missouri United States 63128
    123 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    124 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    125 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    126 Mercy Hospital Springfield Springfield Missouri United States 65804
    127 CoxHealth South Hospital Springfield Missouri United States 65807
    128 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    129 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    130 Billings Clinic Cancer Center Billings Montana United States 59101
    131 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    132 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    133 Great Falls Clinic Great Falls Montana United States 59405
    134 Kalispell Regional Medical Center Kalispell Montana United States 59901
    135 Community Medical Hospital Missoula Montana United States 59804
    136 CHI Health Saint Francis Grand Island Nebraska United States 68803
    137 CHI Health Good Samaritan Kearney Nebraska United States 68847
    138 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    139 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    140 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
    141 Creighton University Medical Center Omaha Nebraska United States 68131
    142 Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada United States 89052
    143 OptumCare Cancer Care at Seven Hills Henderson Nevada United States 89052
    144 OptumCare Cancer Care at Charleston Las Vegas Nevada United States 89102
    145 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
    146 GenesisCare USA - Las Vegas Las Vegas Nevada United States 89109
    147 Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada United States 89119
    148 Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada United States 89128
    149 OptumCare Cancer Care at MountainView Las Vegas Nevada United States 89128
    150 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
    151 Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada United States 89144
    152 Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada United States 89144
    153 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    154 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
    155 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
    156 Renown Regional Medical Center Reno Nevada United States 89502
    157 Saint Mary's Regional Medical Center Reno Nevada United States 89503
    158 Radiation Oncology Associates Reno Nevada United States 89509
    159 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
    160 Garnet Health Medical Center Middletown New York United States 10940
    161 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    162 Bethesda North Hospital Cincinnati Ohio United States 45242
    163 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    164 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    165 Saint Charles Health System Bend Oregon United States 97701
    166 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    167 Providence Cancer Institute Clackamas Clinic Clackamas Oregon United States 97015
    168 Bay Area Hospital Coos Bay Oregon United States 97420
    169 Providence Newberg Medical Center Newberg Oregon United States 97132
    170 Providence Portland Medical Center Portland Oregon United States 97213
    171 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    172 Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania United States 19317
    173 Vanderbilt Breast Center at One Hundred Oaks Nashville Tennessee United States 37204
    174 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    175 Saint Joseph Regional Cancer Center Bryan Texas United States 77802
    176 Providence Regional Cancer System-Aberdeen Aberdeen Washington United States 98520
    177 Overlake Medical Center Bellevue Washington United States 98004
    178 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    179 Harrison Medical Center Bremerton Washington United States 98310
    180 Highline Medical Center-Main Campus Burien Washington United States 98166
    181 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    182 Swedish Cancer Institute-Edmonds Edmonds Washington United States 98026
    183 Providence Regional Cancer Partnership Everett Washington United States 98201
    184 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    185 Providence Regional Cancer System-Lacey Lacey Washington United States 98503
    186 PeaceHealth Saint John Medical Center Longview Washington United States 98632
    187 Valley Medical Center Renton Washington United States 98055
    188 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
    189 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    190 PeaceHealth United General Medical Center Sedro-Woolley Washington United States 98284
    191 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    192 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
    193 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington United States 98902
    194 ThedaCare Regional Cancer Center Appleton Wisconsin United States 54911
    195 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    196 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Kristen K Ciombor, ECOG-ACRIN Cancer Research Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT04751370
    Other Study ID Numbers:
    • NCI-2021-00912
    • NCI-2021-00912
    • EA2201
    • EA2201
    • U10CA180820
    First Posted:
    Feb 12, 2021
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adenocarcinoma
    Rectal Neoplasms
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Aug 25, 2022