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A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

Sponsor
Southwest Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT04511013
Collaborator
National Cancer Institute (NCI) (NIH)
112
Enrollment
310
Locations
2
Arms
81.2
Anticipated Duration (Months)
0.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ipilimumab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. To compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between participants randomized to the triplet combination of encorafenib
  • binimetinib + nivolumab versus the doublet combination of ipilimumab + nivolumab among participants with BRAF-V600 mutant melanoma that has metastasized to the brain.
SECONDARY OBJECTIVES:

  1. To estimate the overall survival (OS) of participants in each treatment arm. II. To estimate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial responses) per RECIST 1.1 in each treatment arm.

  2. To estimate the intracranial response rate (ICRR), defined as confirmed and unconfirmed complete and partial response per modified RECIST for brain metastases (mRECIST).

  3. To evaluate the duration of response, per RECIST 1.1 and the duration of ICRR per mRECIST, and per Response Assessment in Neuro-Oncology (RANO)-Brain Metastases (BM) (and immunotherapy [i]RANO) in each treatment arm.

  4. To evaluate the toxicity profile of each treatment arm. VI. To evaluate current and emerging radiographic response criteria (modified RECIST 1.1, modified RANO-BM and iRANO) by a retrospective blinded independent centralized review (BICR) of banked images.

BANKING OBJECTIVE:
  1. To bank tumor tissue, cerebral spinal fluid (CSF), stool and blood samples for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive encorafenib orally (PO) once daily (QD) on days 1-28, binimetinib PO twice daily (BID) on days 1-28, and nivolumab intravenously (IV) on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years, and then annually until 3 years after randomization.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab vs Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
Actual Study Start Date :
Sep 23, 2020
Anticipated Primary Completion Date :
Jun 30, 2027
Anticipated Study Completion Date :
Jun 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (encorafenib, binimetinib, nivolumab)

Patients receive encorafenib PO QD on days 1-28, binimetinib PO BID on days 1-28, and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Binimetinib
Given PO
Other Names:
  • ARRY-162
  • ARRY-438162
  • MEK162
  • Mektovi

    • Drug: Encorafenib
    Given PO
    Other Names:
  • Braftovi
  • LGX 818
  • LGX-818
  • LGX818

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

    		•
    Experimental: Arm II (nivolumab, ipilimumab)

    Patients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity.

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [From date of registration to date of first documentation of progression, or symptomatic deterioration, or death due to any cause, assessed up to 3 years after randomization]

      Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

    Secondary Outcome Measures

    1. Overall survival (OS) [From date of registration to date of death due to any cause, assessed up to 3 years after randomization]

      Will be assessed by Immunotherapy Response Assessment Criteria for Intracranial Metastases (RANO-BM). Will construct Kaplan-Meier plots and estimate the median OS and construct 95% Brookmeyer-Crowley Confidence intervals.

    2. Intracranial response rate (ICRR) [Up to 3 years after randomization]

      The ICRR is defined as the best response when applying modified (m)RECIST criteria. Will compare intracranial response based on assessments per mRECIST, RANO-BM and immunotherapy (i)RANO criteria based on a review of the banked images. For each of these methods, the best response to treatment will be summarized by treatment arm, the percent agreement between each pair of methods will be reported along with a 95% confidence interval, and a p-value based on a two-sided McNemar's test will be calculated.

    3. Objective response rate [Up to 3 years after randomization]

      Will be assessed by RECIST 1.1.

    4. Duration of response [Up to 3 years after randomization]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants must have histologically and pathologically confirmed melanoma that has metastasized to the brain

    • Any primary (cutaneous, acral/mucosal, etc) or unknown origin are permitted, except that participants with uveal primary are not eligible

    • Participants must have BRAF-V600 mutant melanoma documented by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory

    • All participants must have an magnetic resonance imaging (MRI) of the brain within 28 days prior to registration and must have central nervous system metastases with at least one measurable brain metastasis >= 0.5 cm in size (per modified RECIST 1.1) that has not been irradiated, or progressed (in the opinion of the treating physician) after prior radiation therapy. Participating sites MUST use MRI slice thickness of =< 1.5 mm and are recommended to adhere to the 'minimum' Brain Tumor Imaging Protocol for Clinical Trials in Brain Metastases (BTIP-BM) compliant MRI acquisition protocol. Computed tomography (CT) of the head cannot substitute for brain MRI. (NOTE: All central nervous system [CNS] disease must be documented on BOTH the Brain Metastases Baseline Tumor Assessment Form, using modified RECIST, and the Baseline Tumor Assessment Form [RECIST 1.1] using RECIST 1.1.)

    • Participants may have measurable or non-measurable extracranial disease. All measurable disease must be assessed within 28 days prior to randomization; all non-measurable disease must be assessed within 42 days prior to randomization. Please note, while any extracranial disease will also be assessed and followed, participants are NOT required to have extracranial disease for randomization. NOTE: All disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). CNS disease must be documented on BOTH the Brain Metastases Baseline Tumor Assessment Form, using modified RECIST, and the Baseline Tumor Assessment Form (RECIST 1.1) using RECIST 1.1

    • Participants may have leptomeningeal disease

    • Participants may be receiving corticosteroids for brain metastases at a dose of up to 8 mg of dexamethasone per day. The dose must not have exceeded 8 mg per day for at least 7 days prior to randomization

    • Participants must have Zubrod performance status =< 2

    • Participants must have complete history and physical examination within 28 days prior to randomization

    • Participants must be able to swallow and retain pills

    • Hemoglobin >= 8.0 g/dL (within 28 days prior to randomization)

    • Absolute neutrophil count >= 1,500/mcL (within 28 days prior to randomization)

    • Platelets >= 75,000/mcL (within 28 days prior to randomization)

    • Total bilirubin =< 1.5 institutional upper limit of normal (ULN) (within 28 days prior to randomization)

    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN (in participants with liver metastases =< 5 x ULN) (within 28 days prior to randomization)

    • Creatinine =< 2.0 institutional ULN (within 28 days prior to randomization)

    • Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better

    • Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

    • Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to randomization

    • Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to randomization

    • Participants must agree to participate in image banking. Images must be submitted via the Triad System

    • Participants must be offered the opportunity to participate in specimen and blood collections

    • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

    • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

    Exclusion Criteria:

    • Participants must not have received prior systemic therapy for metastatic disease. Prior systemic therapy received only in the neoadjuvant and/or adjuvant setting (e.g., BRAF/MEK inhibitor therapy, anti-PD-1 therapy or anti-CTLA4 therapy, alfa-interferon, etc.) is permitted. If patients received prior neoadjuvant/adjuvant therapy, they must have had eventual disease relapse prior to randomization

    • Participants must not have had prior radiation therapy within 7 days prior to randomization

    • Participants must not be planning to require any additional form of systemic anti-tumor therapy for melanoma while on protocol treatment

    • Participants must not be planning to use hormonal contraceptives

    • Participants must not have a serious active infection requiring systemic therapy at time of randomization in the opinion of the treating physician

    • Participants must not have active autoimmune disease that has required treatment in the past 6 months with use of biologic disease modifying agents (.e.g. infliximab, adalimumab). Patients on non-biologic disease modifying agents (e.g. methotrexate) or patients on corticosteroids =< 10 mg prednisone daily or equivalent (to treat auto-immune disease), or on replacement therapy (e.g., thyroxine, insulin) are eligible if deemed in the best interest of the patient by treating physician

    • Participants must not have had grade 3 or 4 immune-related adverse events on ipilimumab or nivolumab that required more than 12 weeks of immune suppression with corticosteroids

    • Participants must not have had adverse events related to encorafenib and/or binimetinib specifically, that required discontinuation of one or both drugs. (Please note this does not apply to other BRAF/MEK inhibitor drugs.)

    • Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective method of contraception. (NOTE: Patients must agree to not use hormonal contraceptives, as encorafenib can result in decreased concentration and loss of efficacy.) A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 Anchorage Associates in Radiation Medicine Anchorage Alaska United States 98508
    3 Anchorage Radiation Therapy Center Anchorage Alaska United States 99504
    4 Alaska Breast Care and Surgery LLC Anchorage Alaska United States 99508
    5 Alaska Oncology and Hematology LLC Anchorage Alaska United States 99508
    6 Alaska Women's Cancer Care Anchorage Alaska United States 99508
    7 Anchorage Oncology Centre Anchorage Alaska United States 99508
    8 Katmai Oncology Group Anchorage Alaska United States 99508
    9 Providence Alaska Medical Center Anchorage Alaska United States 99508
    10 Fairbanks Memorial Hospital Fairbanks Alaska United States 99701
    11 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
    12 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    13 Epic Care-Dublin Dublin California United States 94568
    14 Bay Area Breast Surgeons Inc Emeryville California United States 94608
    15 Epic Care Partners in Cancer Care Emeryville California United States 94608
    16 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095
    17 Contra Costa Regional Medical Center Martinez California United States 94553-3156
    18 Alta Bates Summit Medical Center - Summit Campus Oakland California United States 94609
    19 Bay Area Tumor Institute Oakland California United States 94609
    20 Sharp Memorial Hospital San Diego California United States 92123
    21 Epic Care Cyberknife Center Walnut Creek California United States 94597
    22 Rocky Mountain Cancer Centers-Aurora Aurora Colorado United States 80012
    23 The Medical Center of Aurora Aurora Colorado United States 80012
    24 University of Colorado Hospital Aurora Colorado United States 80045
    25 Boulder Community Foothills Hospital Boulder Colorado United States 80303
    26 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
    27 Rocky Mountain Cancer Centers - Centennial Centennial Colorado United States 80112
    28 The Women's Imaging Center Denver Colorado United States 80209
    29 Colorado Blood Cancer Institute Denver Colorado United States 80218
    30 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
    31 Rocky Mountain Cancer Centers-Midtown Denver Colorado United States 80218
    32 Rocky Mountain Cancer Centers-Rose Denver Colorado United States 80220
    33 Rose Medical Center Denver Colorado United States 80220
    34 Western Surgical Care Denver Colorado United States 80220
    35 Mountain Blue Cancer Care Center - Swedish Englewood Colorado United States 80113
    36 Rocky Mountain Cancer Centers - Swedish Englewood Colorado United States 80113
    37 Swedish Medical Center Englewood Colorado United States 80113
    38 The Melanoma and Skin Cancer Institute Englewood Colorado United States 80113
    39 North Colorado Medical Center Greeley Colorado United States 80631
    40 Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado United States 80228
    41 Rocky Mountain Cancer Centers-Littleton Littleton Colorado United States 80120
    42 Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado United States 80124
    43 Sky Ridge Medical Center Lone Tree Colorado United States 80124
    44 McKee Medical Center Loveland Colorado United States 80539
    45 Rocky Mountain Cancer Centers-Thornton Thornton Colorado United States 80260
    46 UM Sylvester Comprehensive Cancer Center at Aventura Aventura Florida United States 33180
    47 UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida United States 33146
    48 UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida United States 33442
    49 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    50 UM Sylvester Comprehensive Cancer Center at Kendall Miami Florida United States 33176
    51 UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida United States 33324
    52 Moffitt Cancer Center-International Plaza Tampa Florida United States 33607
    53 Moffitt Cancer Center - McKinley Campus Tampa Florida United States 33612
    54 Moffitt Cancer Center Tampa Florida United States 33612
    55 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    56 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    57 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    58 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    59 Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho United States 83814
    60 Walter Knox Memorial Hospital Emmett Idaho United States 83617
    61 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    62 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
    63 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    64 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    65 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    66 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
    67 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
    68 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    69 Saint Anthony's Health Alton Illinois United States 62002
    70 Rush - Copley Medical Center Aurora Illinois United States 60504
    71 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    72 Illinois CancerCare-Canton Canton Illinois United States 61520
    73 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
    74 SIH Cancer Institute Carterville Illinois United States 62918
    75 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    76 Centralia Oncology Clinic Centralia Illinois United States 62801
    77 Northwestern University Chicago Illinois United States 60611
    78 Carle on Vermilion Danville Illinois United States 61832
    79 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    80 Decatur Memorial Hospital Decatur Illinois United States 62526
    81 Illinois CancerCare-Dixon Dixon Illinois United States 61021
    82 Carle Physician Group-Effingham Effingham Illinois United States 62401
    83 Crossroads Cancer Center Effingham Illinois United States 62401
    84 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    85 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    86 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    87 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    88 Northwestern Medicine Lake Forest Hospital Lake Forest Illinois United States 60045
    89 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    90 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    91 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    92 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    93 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    94 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    95 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    96 Illinois CancerCare-Peru Peru Illinois United States 61354
    97 Valley Radiation Oncology Peru Illinois United States 61354
    98 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    99 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    100 Springfield Clinic Springfield Illinois United States 62702
    101 Memorial Medical Center Springfield Illinois United States 62781
    102 Southwest Illinois Health Services LLP Swansea Illinois United States 62226
    103 Carle Cancer Center Urbana Illinois United States 61801
    104 The Carle Foundation Hospital Urbana Illinois United States 61801
    105 Illinois CancerCare - Washington Washington Illinois United States 61571
    106 Rush-Copley Healthcare Center Yorkville Illinois United States 60560
    107 Reid Health Richmond Indiana United States 47374
    108 Mary Greeley Medical Center Ames Iowa United States 50010
    109 McFarland Clinic PC - Ames Ames Iowa United States 50010
    110 McFarland Clinic PC-Boone Boone Iowa United States 50036
    111 Saint Anthony Regional Hospital Carroll Iowa United States 51401
    112 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    113 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    114 Broadlawns Medical Center Des Moines Iowa United States 50314
    115 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    116 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
    117 Trinity Regional Medical Center Fort Dodge Iowa United States 50501
    118 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
    119 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
    120 Methodist West Hospital West Des Moines Iowa United States 50266-7700
    121 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
    122 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
    123 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    124 Bronson Battle Creek Battle Creek Michigan United States 49017
    125 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    126 Mercy Health Saint Mary's Grand Rapids Michigan United States 49503
    127 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    128 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    129 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    130 Ascension Borgess Cancer Center Kalamazoo Michigan United States 49009
    131 Borgess Medical Center Kalamazoo Michigan United States 49048
    132 Mercy Health Mercy Campus Muskegon Michigan United States 49444
    133 Lakeland Hospital Niles Niles Michigan United States 49120
    134 Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan United States 49444
    135 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    136 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    137 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    138 Munson Medical Center Traverse City Michigan United States 49684
    139 Metro Health Hospital Wyoming Michigan United States 49519
    140 Fairview Ridges Hospital Burnsville Minnesota United States 55337
    141 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
    142 Cambridge Medical Center Cambridge Minnesota United States 55008
    143 Mercy Hospital Coon Rapids Minnesota United States 55433
    144 Fairview Southdale Hospital Edina Minnesota United States 55435
    145 Unity Hospital Fridley Minnesota United States 55432
    146 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
    147 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
    148 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
    149 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
    150 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    151 Health Partners Inc Minneapolis Minnesota United States 55454
    152 Monticello Cancer Center Monticello Minnesota United States 55362
    153 New Ulm Medical Center New Ulm Minnesota United States 56073
    154 Fairview Northland Medical Center Princeton Minnesota United States 55371
    155 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
    156 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    157 Regions Hospital Saint Paul Minnesota United States 55101
    158 United Hospital Saint Paul Minnesota United States 55102
    159 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
    160 Lakeview Hospital Stillwater Minnesota United States 55082
    161 Ridgeview Medical Center Waconia Minnesota United States 55387
    162 Rice Memorial Hospital Willmar Minnesota United States 56201
    163 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
    164 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
    165 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
    166 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    167 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    168 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    169 Parkland Health Center - Farmington Farmington Missouri United States 63640
    170 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    171 Freeman Health System Joplin Missouri United States 64804
    172 Mercy Hospital Joplin Joplin Missouri United States 64804
    173 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    174 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    175 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    176 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    177 Mercy Hospital South Saint Louis Missouri United States 63128
    178 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    179 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    180 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    181 Mercy Hospital Springfield Springfield Missouri United States 65804
    182 CoxHealth South Hospital Springfield Missouri United States 65807
    183 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    184 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    185 Mercy Hospital Washington Washington Missouri United States 63090
    186 Community Hospital of Anaconda Anaconda Montana United States 59711
    187 Billings Clinic Cancer Center Billings Montana United States 59101
    188 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    189 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    190 Great Falls Clinic Great Falls Montana United States 59405
    191 Kalispell Regional Medical Center Kalispell Montana United States 59901
    192 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    193 Community Medical Hospital Missoula Montana United States 59804
    194 Cancer Partners of Nebraska - Pine Lake Lincoln Nebraska United States 68516
    195 Southeast Nebraska Cancer Center - 68th Street Place Lincoln Nebraska United States 68516
    196 Roswell Park Cancer Institute Buffalo New York United States 14263
    197 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
    198 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    199 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
    200 UHHS-Chagrin Highlands Medical Center Beachwood Ohio United States 44122
    201 Indu and Raj Soin Medical Center Beavercreek Ohio United States 45431
    202 Strecker Cancer Center-Belpre Belpre Ohio United States 45714
    203 Saint Elizabeth Boardman Hospital Boardman Ohio United States 44512
    204 Dayton Physicians LLC-Miami Valley South Centerville Ohio United States 45459
    205 Miami Valley Hospital South Centerville Ohio United States 45459
    206 Geauga Hospital Chardon Ohio United States 44024
    207 Adena Regional Medical Center Chillicothe Ohio United States 45601
    208 University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio United States 45219
    209 Oncology Hematology Care Inc-Kenwood Cincinnati Ohio United States 45236
    210 Case Western Reserve University Cleveland Ohio United States 44106
    211 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    212 Mount Carmel East Hospital Columbus Ohio United States 43213
    213 Columbus Oncology and Hematology Associates Inc Columbus Ohio United States 43214
    214 Riverside Methodist Hospital Columbus Ohio United States 43214
    215 Grant Medical Center Columbus Ohio United States 43215
    216 The Mark H Zangmeister Center Columbus Ohio United States 43219
    217 Mount Carmel Health Center West Columbus Ohio United States 43222
    218 Doctors Hospital Columbus Ohio United States 43228
    219 Miami Valley Hospital Dayton Ohio United States 45409
    220 Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio United States 45415
    221 Miami Valley Hospital North Dayton Ohio United States 45415
    222 Delaware Health Center-Grady Cancer Center Delaware Ohio United States 43015
    223 Grady Memorial Hospital Delaware Ohio United States 43015
    224 Dublin Methodist Hospital Dublin Ohio United States 43016
    225 Armes Family Cancer Center Findlay Ohio United States 45840
    226 Blanchard Valley Hospital Findlay Ohio United States 45840
    227 Orion Cancer Care Findlay Ohio United States 45840
    228 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
    229 Dayton Physicians LLC-Atrium Franklin Ohio United States 45005
    230 Central Ohio Breast and Endocrine Surgery Gahanna Ohio United States 43230
    231 Dayton Physicians LLC-Wayne Greenville Ohio United States 45331
    232 Wayne Hospital Greenville Ohio United States 45331
    233 Mount Carmel Grove City Hospital Grove City Ohio United States 43123
    234 Greater Dayton Cancer Center Kettering Ohio United States 45409
    235 Kettering Medical Center Kettering Ohio United States 45429
    236 Fairfield Medical Center Lancaster Ohio United States 43130
    237 Saint Rita's Medical Center Lima Ohio United States 45801
    238 OhioHealth Mansfield Hospital Mansfield Ohio United States 44903
    239 Marietta Memorial Hospital Marietta Ohio United States 45750
    240 OhioHealth Marion General Hospital Marion Ohio United States 43302
    241 UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio United States 44130
    242 Knox Community Hospital Mount Vernon Ohio United States 43050
    243 Licking Memorial Hospital Newark Ohio United States 43055
    244 Newark Radiation Oncology Newark Ohio United States 43055
    245 University Hospitals Parma Medical Center Parma Ohio United States 44129
    246 Mercy Health Perrysburg Cancer Center Perrysburg Ohio United States 43551
    247 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    248 University Hospitals Portage Medical Center Ravenna Ohio United States 44266
    249 UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio United States 44870
    250 Springfield Regional Cancer Center Springfield Ohio United States 45504
    251 Springfield Regional Medical Center Springfield Ohio United States 45505
    252 Saint Vincent Mercy Medical Center Toledo Ohio United States 43608
    253 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
    254 Dayton Physicians LLC-Upper Valley Troy Ohio United States 45373
    255 Upper Valley Medical Center Troy Ohio United States 45373
    256 University Hospitals Sharon Health Center Wadsworth Ohio United States 44281
    257 Saint Joseph Warren Hospital Warren Ohio United States 44484
    258 University of Cincinnati Cancer Center-West Chester West Chester Ohio United States 45069
    259 Saint Ann's Hospital Westerville Ohio United States 43081
    260 UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio United States 44145
    261 Saint Elizabeth Youngstown Hospital Youngstown Ohio United States 44501
    262 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    263 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    264 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    265 Saint Alphonsus Medical Center-Baker City Baker City Oregon United States 97814
    266 Saint Charles Health System Bend Oregon United States 97701
    267 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    268 Providence Cancer Institute Clackamas Clinic Clackamas Oregon United States 97015
    269 Bay Area Hospital Coos Bay Oregon United States 97420
    270 Providence Newberg Medical Center Newberg Oregon United States 97132
    271 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
    272 Providence Portland Medical Center Portland Oregon United States 97213
    273 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    274 Saint Charles Health System-Redmond Redmond Oregon United States 97756
    275 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
    276 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    277 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    278 Providence Regional Cancer System-Aberdeen Aberdeen Washington United States 98520
    279 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    280 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    281 Swedish Cancer Institute-Edmonds Edmonds Washington United States 98026
    282 Providence Regional Cancer Partnership Everett Washington United States 98201
    283 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    284 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
    285 Providence Regional Cancer System-Lacey Lacey Washington United States 98503
    286 PeaceHealth Saint John Medical Center Longview Washington United States 98632
    287 Jefferson Healthcare Port Townsend Washington United States 98368
    288 Pacific Gynecology Specialists Seattle Washington United States 98104
    289 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
    290 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    291 Swedish Medical Center-Cherry Hill Seattle Washington United States 98122-5711
    292 PeaceHealth United General Medical Center Sedro-Woolley Washington United States 98284
    293 Providence Regional Cancer System-Shelton Shelton Washington United States 98584
    294 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    295 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
    296 Providence Regional Cancer System-Yelm Yelm Washington United States 98597
    297 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
    298 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    299 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    300 Aspirus Medford Hospital Medford Wisconsin United States 54451
    301 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    302 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
    303 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    304 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
    305 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
    306 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
    307 Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin United States 54494
    308 Cheyenne Regional Medical Center-West Cheyenne Wyoming United States 82001
    309 Billings Clinic-Cody Cody Wyoming United States 82414
    310 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Zeynep Eroglu, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT04511013
    Other Study ID Numbers:
    • S2000
    • NCI-2020-05496
    • S2000
    • S2000
    • U10CA180888
    First Posted:
    Aug 12, 2020
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Melanoma
    Brain Neoplasms
    Neoplasms
    Skin Neoplasms
    Nivolumab
    Ipilimumab

    Study Results

    No Results Posted as of Nov 9, 2021