Phase
Condition
Melanoma
Treatment
cemiplimab
relatlimab+nivolumab
fianlimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revisededition.
Participants must not have received prior systemic therapy for unresectable ormetastatic melanoma as described in the protocol.
Measurable disease per RECIST version 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
Adequate bone marrow, hepatic, and kidney function
Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status orsubmitted sample for BRAF V600 mutation assessment as described in the protocol
Exclusion
Key Exclusion Criteria:
Medical Conditions:
Uveal, acral or mucosal melanoma.
Ongoing or recent (within 2 years) evidence of an autoimmune disease that requiredsystemic treatment with immunosuppressive agents as described in the protocol.
Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV),or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that isrelated to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic orrecurrent infection) is allowed. Prior/Concomitant Therapy:
Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described inthe protocol
Systemic immune suppression as described in the protocol. Other Comorbidities:
Participants with a history of myocarditis.
Troponin T (TnT) or troponin I (TnI) >2x institutional upper limit of normal (ULN).
Active or untreated brain metastases or spinal cord compression as described in theprotocol.
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply.
Study Design
Connect with a study center
London Regional Cancer Centre
London, Ontario N6A 5W9
CanadaSite Not Available
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
CanadaActive - Recruiting
London Regional Cancer Centre
London 6058560, Ontario 6093943 N6A 5W9
CanadaActive - Recruiting
Princess Margaret Cancer Centre
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaActive - Recruiting
Sunnybrook Health Sciences Centre
Toronto 6167865, Ontario 6093943 M4N 3M5
CanadaActive - Recruiting
Centre Hospitalier Universitaire de Quebec (CHUQ) - Centre Hospitalier de l'Universite Laval (CHUL)
Quebec, G1G 5X1
CanadaSite Not Available
Centre Hospitalier Universitaire de Quebec (CHUQ) - Centre Hospitalier de l'Universite Laval (CHUL)
Québec 6325494, G1J 0J9
CanadaActive - Recruiting
Ironwood Cancer & Research Centers
Chandler, Arizona 85224
United StatesSite Not Available
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United StatesSite Not Available
Arizona Oncology Associates
Tucson, Arizona 85711
United StatesSite Not Available
Ironwood Cancer & Research Centers
Chandler 5289282, Arizona 5551752 85224
United StatesActive - Recruiting
Banner MD Anderson Cancer Center
Gilbert 5295903, Arizona 5551752 85234
United StatesActive - Recruiting
Arizona Oncology Associates
Tucson 5318313, Arizona 5551752 85711
United StatesSite Not Available
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesSite Not Available
University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205
United StatesActive - Recruiting
Providence Medical Foundation
Fullerton, California 92835
United StatesSite Not Available
Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
United StatesSite Not Available
UCLA
Los Angeles, California 90095
United StatesActive - Recruiting
University of California Los Angeles
Los Angeles, California 90095
United StatesSite Not Available
St. Joseph Hospital Orange
Orange, California 92868
United StatesSite Not Available
Eisenhower Medical Center
Rancho Mirage, California 92270
United StatesSite Not Available
Sutter Health
Sacramento, California 95816
United StatesSite Not Available
UCSF
San Francisco, California 94143
United StatesActive - Recruiting
University of California San Francisco (UCSF)
San Francisco, California 94143
United StatesSite Not Available
Sansum Clinic
Santa Barbara, California 93105
United StatesSite Not Available
St John's Cancer Institute
Santa Monica, California 90404
United StatesSite Not Available
Providence Medical Foundation
Fullerton 5351247, California 5332921 92835
United StatesActive - Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos 5368304, California 5332921 90720
United StatesActive - Recruiting
University of California Los Angeles
Los Angeles 5368361, California 5332921 90024
United StatesActive - Recruiting
St. Joseph Hospital Orange
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
Eisenhower Medical Center
Rancho Mirage 5386015, California 5332921 92270
United StatesActive - Recruiting
Sutter Health
Sacramento 5389489, California 5332921 95816
United StatesActive - Recruiting
University of California San Francisco (UCSF)
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
Sansum Clinic
Santa Barbara 5392952, California 5332921 93105
United StatesActive - Recruiting
St John's Cancer Institute
Santa Monica 5393212, California 5332921 90404
United StatesActive - Recruiting
Rocky Mountain Regional VA Medical Center
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Colorado Cancer Center
Aurora, Colorado 80045
United StatesSite Not Available
The Melanoma And Skin Cancer Institute
Englewood, Colorado 80113
United StatesSite Not Available
UCHealth
Fort Collins, Colorado 80528
United StatesSite Not Available
Rocky Mountain Regional VA Medical Center
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
University of Colorado Cancer Center
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
The Melanoma And Skin Cancer Institute
Englewood 5421250, Colorado 5417618 80113
United StatesActive - Recruiting
UCHealth
Fort Collins 5577147, Colorado 5417618 80528
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06510
United StatesSite Not Available
Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06510
United StatesActive - Recruiting
Clermont Oncology Center
Clermont, Florida 34711
United StatesSite Not Available
Cancer Specialist of North Florida
Jacksonville, Florida 32256
United StatesActive - Recruiting
Mayo Clinic Florida
Jacksonville, Florida 32224
United StatesSite Not Available
Boca Raton Clinical Research (BRCR) Global
Plantation, Florida 33322
United StatesSite Not Available
Boca Raton Clinical Research (BRCR) Global
Tamarac, Florida 33321
United StatesSite Not Available
H. Lee Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Clermont Oncology Center
Clermont 4151352, Florida 4155751 34711
United StatesActive - Recruiting
Cancer Specialist of North Florida
Jacksonville 4160021, Florida 4155751 32256
United StatesActive - Recruiting
Mayo Clinic Florida
Jacksonville 4160021, Florida 4155751 32224
United StatesActive - Recruiting
Boca Raton Clinical Research (BRCR) Global
Tamarac 4174738, Florida 4155751 33321
United StatesActive - Recruiting
H. Lee Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
United StatesActive - Recruiting
University Cancer & Blood Center
Athens, Georgia 30607
United StatesSite Not Available
John B. Amos Cancer Center
Columbus, Georgia 31904
United StatesSite Not Available
University Cancer & Blood Center
Athens 4180386, Georgia 4197000 30607
United StatesActive - Recruiting
John B. Amos Cancer Center
Columbus 4188985, Georgia 4197000 31904
United StatesSite Not Available
Beacon Clinic
Coeur d'Alene, Idaho 83815
United StatesSite Not Available
Beacon Clinic
Coeur d'Alene 5589173, Idaho 5596512 83815
United StatesActive - Recruiting
Hope and Healing Cancer Services
Hinsdale, Illinois 60521
United StatesSite Not Available
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
United StatesSite Not Available
Illinois CancerCare
Peoria, Illinois 61615
United StatesSite Not Available
Hope and Healing Cancer Services
Hinsdale 4896012, Illinois 4896861 60521
United StatesActive - Recruiting
Advocate Lutheran General Hospital
Park Ridge 4905367, Illinois 4896861 60068
United StatesActive - Recruiting
Illinois CancerCare
Peoria 4905687, Illinois 4896861 61615
United StatesActive - Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46825-1623
United StatesSite Not Available
Fort Wayne Medical Oncology and Hematology
Fort Wayne 4920423, Indiana 4921868 46825
United StatesActive - Recruiting
The University of Kansas Cancer Center
Westwood, Kansas 66205
United StatesSite Not Available
The University of Kansas Cancer Center
Westwood 4281639, Kansas 4273857 66205
United StatesActive - Recruiting
Markey Cancer Center Clinical Research Organization
Lexington, Kentucky 40536-0093
United StatesSite Not Available
Markey Cancer Center Clinical Research Organization
Lexington 4297983, Kentucky 6254925 40536
United StatesActive - Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Mary Bird Perkins Cancer Center
Baton Rouge 4315588, Louisiana 4331987 70809
United StatesActive - Recruiting
Maryland Oncology Hematology, P.A.
Columbia, Maryland 21044
United StatesSite Not Available
Maryland Oncology Hematology, P.A.
Columbia 4352053, Maryland 4361885 21044
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48109
United StatesActive - Recruiting
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
United StatesActive - Recruiting
Minnesota Oncology Hematology, P.A
Fridley, Minnesota 55424
United StatesSite Not Available
Allina Health Cancer Institute
Minneapolis, Minnesota 55407
United StatesSite Not Available
Minnesota Oncology Hematology, P.A
Fridley 5027482, Minnesota 5037779 55432
United StatesActive - Recruiting
Allina Health Cancer Institute
Minneapolis 5037649, Minnesota 5037779 55407
United StatesActive - Recruiting
Mercy South
Saint Louis, Missouri 63128
United StatesSite Not Available
VA St. Louis Healthcare System
Saint Louis, Missouri 63106
United StatesActive - Recruiting
Washington University
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Mercy South
St Louis 4407066, Missouri 4398678 63128
United StatesActive - Recruiting
VA St. Louis Healthcare System
St Louis 4407066, Missouri 4398678 63106
United StatesActive - Recruiting
Washington University
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
St. Vincent Healthcare
Billings, Montana 59102
United StatesSite Not Available
St. Vincent Healthcare
Billings 5640350, Montana 5667009 59102
United StatesActive - Recruiting
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
United StatesSite Not Available
Oncology Hematology West, P.C. dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
United StatesActive - Recruiting
Regeneron Study Facility
Omaha, Nebraska 68130
United StatesActive - Recruiting
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
Omaha 5074472, Nebraska 5073708 68130
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada - Southwest
Las Vegas, Nevada 89148
United StatesActive - Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas 5506956, Nevada 5509151 89148
United StatesActive - Recruiting
John Theurer Cancer Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United StatesSite Not Available
The Valley Hospital Inc.
Paramus, New Jersey 07652
United StatesSite Not Available
John Theurer Cancer Center
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901
United StatesActive - Recruiting
The Valley Hospital Inc.
Paramus 5102387, New Jersey 5101760 07652
United StatesActive - Recruiting
New York Oncology Hematology
Albany, New York 12206
United StatesSite Not Available
New York Oncology Hematology
Albany 5106834, New York 5128638 12206
United StatesActive - Recruiting
Messino Cancer Center
Asheville, North Carolina 28806
United StatesSite Not Available
Levine Cancer Institute
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Novant Health Cancer Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
Novant Health Weisiger Cancer Institute - Charlotte
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Duke Health System
Durham, North Carolina 27710
United StatesSite Not Available
Novant Health Zimmer Cancer Institute - Wilmington
Wilmington, North Carolina 28401
United StatesSite Not Available
Messino Cancer Center
Asheville 4453066, North Carolina 4482348 28806
United StatesActive - Recruiting
Levine Cancer Institute
Charlotte 4460243, North Carolina 4482348 28204
United StatesActive - Recruiting
Novant Health Cancer Institute
Charlotte 4460243, North Carolina 4482348 28204
United StatesActive - Recruiting
Novant Health Weisiger Cancer Institute - Charlotte
Charlotte 4460243, North Carolina 4482348 28204
United StatesActive - Recruiting
Duke Health System
Durham 4464368, North Carolina 4482348 27710
United StatesActive - Recruiting
Novant Health Zimmer Cancer Institute - Wilmington
Wilmington 4499379, North Carolina 4482348 28401
United StatesActive - Recruiting
Oncology Hematology Care Clinical Trials
Cincinnati, Ohio 45242
United StatesSite Not Available
Seidman Cancer Center
Cleveland, Ohio 44106
United StatesSite Not Available
Oncology Hematology Care Clinical Trials
Cincinnati 4508722, Ohio 5165418 45242
United StatesActive - Recruiting
Seidman Cancer Center
Cleveland 5150529, Ohio 5165418 44106
United StatesActive - Recruiting
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma 74146
United StatesSite Not Available
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa 4553433, Oklahoma 4544379 74146
United StatesActive - Recruiting
Oncology Associates of Oregon PC
Eugene, Oregon 97401
United StatesSite Not Available
Kaiser Foundation Hospitals
Portland, Oregon 97227
United StatesSite Not Available
Oncology Associates of Oregon PC
Eugene 5725846, Oregon 5744337 97401
United StatesActive - Recruiting
Kaiser Foundation Hospitals
Portland 5746545, Oregon 5744337 97227
United StatesActive - Recruiting
Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239
United StatesActive - Recruiting
St. Luke's University Health Network
Easton, Pennsylvania 18045
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
St. Luke's University Health Network
Easton 5188140, Pennsylvania 6254927 18045
United StatesActive - Recruiting
Fox Chase Cancer Center
Philadelphia 4560349, Pennsylvania 6254927 19111
United StatesActive - Recruiting
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
United StatesActive - Recruiting
Lifespan Cancer Institute
Providence, Rhode Island 02903
United StatesSite Not Available
Lifespan Cancer Institute
Providence 5224151, Rhode Island 5224323 02903
United StatesActive - Recruiting
Saint Francis Cancer Center
Greenville, South Carolina 29607
United StatesSite Not Available
Saint Francis Cancer Center
Greenville 4580543, South Carolina 4597040 29607
United StatesActive - Recruiting
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee 37404
United StatesSite Not Available
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United StatesSite Not Available
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
Tennessee Oncology
Nashville, Tennessee 37203
United StatesSite Not Available
Tennessee Oncology - Chattanooga
Chattanooga 4612862, Tennessee 4662168 37404
United StatesActive - Recruiting
University of Tennessee Medical Center
Knoxville 4634946, Tennessee 4662168 37920
United StatesActive - Recruiting
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
Texas Oncology - Austin Central, Central Austin Cancer Center
Austin, Texas 78731
United StatesActive - Recruiting
Texas Oncology - Austin Midtown, Midtown Medical Center I
Austin, Texas 78705
United StatesSite Not Available
Texas Oncology - Bedford
Bedford, Texas 76022
United StatesSite Not Available
Texas Oncology
Dallas, Texas 75246
United StatesActive - Recruiting
Texas Oncology - Medical City
Dallas, Texas 75230
United StatesSite Not Available
Center For Disease And Blood Disorder
Fort Worth, Texas 76104
United StatesActive - Recruiting
Texas Oncology - Fort Worth
Fort Worth, Texas 76104
United StatesSite Not Available
Texas Oncology - Grapevine
Grapevine, Texas 76051
United StatesSite Not Available
Texas Oncology - Harlingen, Medical Arts Pavillion
Harlingen, Texas 78550
United StatesSite Not Available
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Texas Oncology - Longview
Longview, Texas 75601
United StatesSite Not Available
Joe Arrington Cancer Research & Treatment Center
Lubbock, Texas 79410
United StatesSite Not Available
Texas Oncology - McAllen
McAllen, Texas 78503
United StatesSite Not Available
Texas Oncology-Palestine Cancer Center
Palestine, Texas 75801
United StatesSite Not Available
Texas Oncology-Tyler, Northeast Texas Cancer Institute
Tyler, Texas 75702
United StatesSite Not Available
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center
Tyler, Texas 75701
United StatesActive - Recruiting
Texas Oncology - Weslaco, Knapp Medical Plaza
Weslaco, Texas 78596
United StatesSite Not Available
Texas Oncology - Austin Central, Central Austin Cancer Center
Austin 4671654, Texas 4736286 78731
United StatesActive - Recruiting
Texas Oncology - Austin Midtown, Midtown Medical Center I
Austin 4671654, Texas 4736286 78705
United StatesActive - Recruiting
Texas Oncology - Bedford
Bedford 4673094, Texas 4736286 76022
United StatesActive - Recruiting
Texas Oncology
Dallas 4684888, Texas 4736286 75246
United StatesActive - Recruiting
Texas Oncology - Medical City
Dallas 4684888, Texas 4736286 75230
United StatesActive - Recruiting
Center For Disease And Blood Disorder
Fort Worth 4691930, Texas 4736286 76104
United StatesActive - Recruiting
Texas Oncology - Fort Worth
Fort Worth 4691930, Texas 4736286 76104
United StatesActive - Recruiting
Texas Oncology - Grapevine
Grapevine 4694568, Texas 4736286 76051
United StatesActive - Recruiting
Texas Oncology - Harlingen, Medical Arts Pavillion
Harlingen 4696233, Texas 4736286 78550
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Texas Oncology - Longview
Longview 4707814, Texas 4736286 75601
United StatesActive - Recruiting
Joe Arrington Cancer Research & Treatment Center
Lubbock 5525577, Texas 4736286 79410
United StatesActive - Recruiting
Texas Oncology - McAllen
McAllen 4709796, Texas 4736286 78503
United StatesActive - Recruiting
Texas Oncology-Palestine Cancer Center
Palestine 4717232, Texas 4736286 75801
United StatesActive - Recruiting
Texas Oncology-Tyler, Northeast Texas Cancer Institute
Tyler 4738214, Texas 4736286 75702
United StatesActive - Recruiting
The University of Texas Health Science Center at Tyler D/B/A UT Health East Texas HOPE Cancer Center
Tyler 4738214, Texas 4736286 75701
United StatesSite Not Available
Texas Oncology - Weslaco, Knapp Medical Plaza
Weslaco 4740629, Texas 4736286 78596
United StatesActive - Recruiting
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
University of Utah Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030 84112
United StatesActive - Recruiting
University of Virginia
Charlottesville, Virginia 22908
United StatesSite Not Available
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United StatesSite Not Available
Virginia Oncology Associates
Norfolk, Virginia 23502
United StatesSite Not Available
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia 23298
United StatesSite Not Available
Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia 24014
United StatesSite Not Available
University of Virginia
Charlottesville 4752031, Virginia 6254928 22908
United StatesActive - Recruiting
Virginia Cancer Specialists, PC
Fairfax 4758023, Virginia 6254928 22031
United StatesActive - Recruiting
Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502
United StatesActive - Recruiting
Virginia Commonwealth University Massey Cancer Center
Richmond 4781708, Virginia 6254928 23298
United StatesActive - Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke 4782167, Virginia 6254928 24014
United StatesActive - Recruiting
Swedish Cancer Institute - Edmonds Campus
Edmonds, Washington 98026
United StatesSite Not Available
Swedish Cancer Institute - Issaquah Campus
Issaquah, Washington 98029
United StatesSite Not Available
Swedish Cancer Institute
Seattle, Washington 98104-3551
United StatesSite Not Available
Swedish Cancer Institute - Edmonds Campus
Edmonds 5793427, Washington 5815135 98026
United StatesActive - Recruiting
Swedish Cancer Institute - Issaquah Campus
Issaquah 5798487, Washington 5815135 98029
United StatesActive - Recruiting
Swedish Cancer Institute
Seattle 5809844, Washington 5815135 98104
United StatesActive - Recruiting
West Virginia University
Morgantown, West Virginia 26506
United StatesSite Not Available
West Virginia University (Please Use)
Morgantown, West Virginia 26506
United StatesActive - Recruiting
West Virginia University
Morgantown 4815352, West Virginia 4826850 26506
United StatesActive - Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
United StatesSite Not Available
University of Wisconsin Carbone Cancer Center
Madison 5261457, Wisconsin 5279468 53792
United StatesActive - Recruiting

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