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Brief Title: 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)
Official Title: A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
Study ID: NCT03668119
Brief Summary: The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.
Detailed Description:
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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, Cordoba, , 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, Bruxelles, , 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, Metropolitana, Chile
Local Institution - 0082, Santiago, Metropolitana, Chile
Local Institution - 0080, Copenhagen, , Denmark
Local Institution - 0081, Herlev, , Denmark
Local Institution - 0072, Lyon Cedex 08, , France
Local Institution - 0075, Marseille Cedex 9, , France
Local Institution - 0073, Paris Cedex 5, , 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, Wuerzburg, , Germany
Local Institution - 0032, Genova, , Italy
IRCCS Istituto Nazionale Tumori Milano, Milano, , Italy
Local Institution - 0029, Napoli, , Italy
Local Institution - 0031, Siena, , Italy
Local Institution - 0116, Rotterdam, Zuid-Holland, Netherlands
Local Institution - 0115, Amsterdam, , Netherlands
Local Institution - 0076, Warszawa, Mazowieckie, Poland
Local Institution - 0077, Gdansk, , Poland
Fundacion De Investigacion, San Juan, , Puerto Rico
Local Institution - 0068, Cluj-Napoca, Cluj, Romania
Local Institution - 0069, Bucuresti, , Romania
Local Institution - 0067, Craiova, , Romania
Local Institution - 0070, Floresti, , Romania
Local Institution - 0071, Timisoara, Timis, , Romania
Local Institution - 0066, Singapore, , Singapore
Local Institution - 0065, 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
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR