A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
NCT ID: NCT03668119
Last Updated: 2024-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
212 participants
INTERVENTIONAL
2018-10-31
2023-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nivolumab + Ipilimumab Combination
Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Nivolumab Monotherapy
Nivolumab
Specified dose on specified days
Interventions
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Nivolumab
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be able to provide tissue and blood TMB-H testing results
* Must have measurable disease for response assessment
Exclusion Criteria
* Participants who received prior treatment with an anti-programmed death-1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1), anti-programmed death ligand 2 (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
* Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment
12 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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John Wayne Cancer Center
Santa Monica, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Local Institution - 0093
Minneapolis, Minnesota, United States
Broome Oncology
Johnson City, New York, United States
Duke Cancer Institute
Durham, North Carolina, United States
Local Institution - 0079
Portland, Oregon, United States
Local Institution - 0095
Austin, Texas, United States
Local Institution - 0094
Dallas, Texas, United States
Local Institution - 0090
Houston, Texas, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Local Institution - 0016
Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
Local Institution - 0087
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0078
CABA, , Argentina
Local Institution - 0015
CABA, , Argentina
Local Institution - 0119
Córdoba, , Argentina
Local Institution - 0118
St Leonards, New South Wales, Australia
Local Institution - 0062
Sydney, New South Wales, Australia
Local Institution - 0117
Woolloongabba, Queensland, Australia
Local Institution - 0112
Brussels, , Belgium
Local Institution - 0113
Brussels, , Belgium
Local Institution - 0114
Leuven, , Belgium
Local Institution - 0010
Edmonton, Alberta, Canada
Local Institution - 0060
Hamilton, Ontario, Canada
Local Institution - 0036
Montreal, Quebec, Canada
Local Institution - 0088
Montreal, Quebec, Canada
Local Institution - 0018
Santiago, Santiago Metropolitan, Chile
Local Institution - 0082
Santiago, Santiago Metropolitan, Chile
Local Institution - 0080
Copenhagen, , Denmark
Local Institution - 0081
Herlev, , Denmark
Local Institution - 0072
Lyon, , France
Local Institution - 0075
Marseille, , France
Local Institution - 0073
Paris, , France
Local Institution - 0074
Toulouse, , France
Local Institution - 0085
Villejuif, , France
Local Institution - 0039
Berlin, , Germany
Local Institution - 0001
Bonn, , Germany
Local Institution - 0002
Dresden, , Germany
Local Institution - 0086
Essen, , Germany
Local Institution - 0043
Würzburg, , Germany
Local Institution - 0032
Genova, , Italy
IRCCS Istituto Nazionale Tumori Milano
Milan, , Italy
Local Institution - 0029
Napoli, , Italy
Local Institution - 0031
Siena, , Italy
Local Institution - 0116
Rotterdam, South Holland, Netherlands
Local Institution - 0115
Amsterdam, , Netherlands
Local Institution - 0076
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0077
Gdansk, , Poland
Fundacion De Investigacion
San Juan, , Puerto Rico
Local Institution - 0068
Cluj-Napoca, Cluj, Romania
Local Institution - 0069
Bucharest, , Romania
Local Institution - 0067
Craiova, , Romania
Local Institution - 0070
Floreşti, , Romania
Local Institution - 0071
Timisoara, Timis, , Romania
Local Institution - 0065
Singapore, Central Singapore, Singapore
Local Institution - 0066
Singapore, , Singapore
Local Institution - 0084
Barcelona, , Spain
Local Institution - 0083
Madrid, , Spain
Local Institution - 0110
Pamplona, , Spain
Local Institution - 0106
London, Greater London, United Kingdom
Local Institution - 0107
Preston, , United Kingdom
Countries
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References
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Schenker M, Burotto M, Richardet M, Ciuleanu TE, Goncalves A, Steeghs N, Schoffski P, Ascierto PA, Maio M, Lugowska I, Lupinacci L, Leary A, Delord JP, Grasselli J, Tan DSP, Friedmann J, Vuky J, Tschaika M, Konduru S, Vemula SV, Slepetis R, Kollia G, Pacius M, Duong Q, Huang N, Doshi P, Baden J, Di Nicola M. Randomized, open-label, phase 2 study of nivolumab plus ipilimumab or nivolumab monotherapy in patients with advanced or metastatic solid tumors of high tumor mutational burden. J Immunother Cancer. 2024 Aug 6;12(8):e008872. doi: 10.1136/jitc-2024-008872.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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2016-002898-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-848
Identifier Type: -
Identifier Source: org_study_id
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