A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors
NCT ID: NCT01928394
Last Updated: 2024-12-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
1163 participants
INTERVENTIONAL
2013-10-24
2024-11-18
Brief Summary
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Detailed Description
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Triple Negative Breast Cancer
Gastric Cancer
Pancreatic Cancer
Small Cell Lung Cancer
Bladder Cancer
Ovarian Cancer
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm N - Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Nivolumab
Arm N-I, Level 1: Nivolumab+Ipilimumab
Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 1 mg/kg solution every 3 weeks for 4 doses followed by Nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Nivolumab
Ipilimumab
Arm N-I, Level 2: Nivolumab+Ipilimumab
Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Nivolumab
Ipilimumab
Arm N-I, Level 2b: Nivolumab+Ipilimumab
Nivolumab 3 mg/kg solution intravenously plus Ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Nivolumab
Ipilimumab
Arm N-I, Level 2c: Nivolumab+Ipilimumab
Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Nivolumab
Ipilimumab
Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib
Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks and cobimetinib 60mg once daily 21days on/7 days off until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Nivolumab
Ipilimumab
Cobimetinib
Interventions
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Nivolumab
Ipilimumab
Cobimetinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Triple Negative Breast Cancer
* Gastric Cancer
* Pancreatic Cancer
* Small Cell Lung Cancer
* Bladder Cancer
* Ovarian Cancer
* Subjects must have measurable disease
* Eastern Cooperative Oncology Group (ECOG) of 0 or 1
* Adequate hematological and organ function as confirmed by laboratory values
Exclusion Criteria
* Subjects with active, known or suspected autoimmune disease
* Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
* Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, including Ipilimumab; or other medicines specifically targeting T cell is also prohibited
18 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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Local Institution - 0047
Muscle Shoals, Alabama, United States
Local Institution - 0044
Aurora, Colorado, United States
Local Institution - 0015
New Haven, Connecticut, United States
Local Institution - 0046
Gainesville, Florida, United States
Local Institution - 0021
Tampa, Florida, United States
Local Institution - 0001
Atlanta, Georgia, United States
Local Institution - 0004
Baltimore, Maryland, United States
Local Institution - 0005
Boston, Massachusetts, United States
Local Institution - 0043
Boston, Massachusetts, United States
Local Institution - 0049
Omaha, Nebraska, United States
Local Institution - 0045
Mineola, New York, United States
Local Institution - 0006
New York, New York, United States
Local Institution - 0003
Charlotte, North Carolina, United States
Local Institution - 0008
Durham, North Carolina, United States
Local Institution - 0007
Portland, Oregon, United States
Local Institution - 0011
Franklin, Tennessee, United States
Local Institution - 0002
Nashville, Tennessee, United States
Local Institution - 0009
Houston, Texas, United States
Local Institution - 0042
Seattle, Washington, United States
Local Institution - 0038
Toronto, Ontario, Canada
Local Institution - 0039
Copenhagen, , Denmark
Local Institution - 0014
Helsinki, Uusimaa, Finland
Local Institution - 0036
Tampere, , Finland
Local Institution - 0048
Bonn, , Germany
Local Institution - 0026
Frankfurt, , Germany
Local Institution - 0016
Heidelberg, , Germany
Local Institution - 0050
Kassel, , Germany
Local Institution - 0024
Bologna, , Italy
Local Institution - 0019
Milan, , Italy
Local Institution - 0020
Napoli, , Italy
Local Institution - 0032
Padua, , Italy
Local Institution - 0037
Barcelona, , Spain
Local Institution - 0023
Madrid, , Spain
Local Institution - 0017
Madrid, , Spain
Local Institution - 0010
Madrid, , Spain
Local Institution - 0018
London, Greater London, United Kingdom
Local Institution - 0012
Glasgow, Lanarkshire, United Kingdom
Local Institution - 0013
Sutton, Surrey, United Kingdom
Countries
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References
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Sharma P, Siefker-Radtke A, de Braud F, Basso U, Calvo E, Bono P, Morse MA, Ascierto PA, Lopez-Martin J, Brossart P, Rohrberg K, Mellado B, Fischer BS, Meadows-Shropshire S, Abdel Saci, Callahan MK, Rosenberg J. Nivolumab Alone and With Ipilimumab in Previously Treated Metastatic Urothelial Carcinoma: CheckMate 032 Nivolumab 1 mg/kg Plus Ipilimumab 3 mg/kg Expansion Cohort Results. J Clin Oncol. 2019 Jul 1;37(19):1608-1616. doi: 10.1200/JCO.19.00538. Epub 2019 May 17.
Janjigian YY, Bendell J, Calvo E, Kim JW, Ascierto PA, Sharma P, Ott PA, Peltola K, Jaeger D, Evans J, de Braud F, Chau I, Harbison CT, Dorange C, Tschaika M, Le DT. CheckMate-032 Study: Efficacy and Safety of Nivolumab and Nivolumab Plus Ipilimumab in Patients With Metastatic Esophagogastric Cancer. J Clin Oncol. 2018 Oct 1;36(28):2836-2844. doi: 10.1200/JCO.2017.76.6212. Epub 2018 Aug 15.
Teo MY, Seier K, Ostrovnaya I, Regazzi AM, Kania BE, Moran MM, Cipolla CK, Bluth MJ, Chaim J, Al-Ahmadie H, Snyder A, Carlo MI, Solit DB, Berger MF, Funt S, Wolchok JD, Iyer G, Bajorin DF, Callahan MK, Rosenberg JE. Alterations in DNA Damage Response and Repair Genes as Potential Marker of Clinical Benefit From PD-1/PD-L1 Blockade in Advanced Urothelial Cancers. J Clin Oncol. 2018 Jun 10;36(17):1685-1694. doi: 10.1200/JCO.2017.75.7740. Epub 2018 Feb 28.
Sharma P, Callahan MK, Bono P, Kim J, Spiliopoulou P, Calvo E, Pillai RN, Ott PA, de Braud F, Morse M, Le DT, Jaeger D, Chan E, Harbison C, Lin CS, Tschaika M, Azrilevich A, Rosenberg JE. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. Lancet Oncol. 2016 Nov;17(11):1590-1598. doi: 10.1016/S1470-2045(16)30496-X. Epub 2016 Oct 9.
Antonia SJ, Lopez-Martin JA, Bendell J, Ott PA, Taylor M, Eder JP, Jager D, Pietanza MC, Le DT, de Braud F, Morse MA, Ascierto PA, Horn L, Amin A, Pillai RN, Evans J, Chau I, Bono P, Atmaca A, Sharma P, Harbison CT, Lin CS, Christensen O, Calvo E. Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial. Lancet Oncol. 2016 Jul;17(7):883-895. doi: 10.1016/S1470-2045(16)30098-5. Epub 2016 Jun 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2013-002844-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-032
Identifier Type: -
Identifier Source: org_study_id