Bladder Cancer Clinical Trial
An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors
Summary
The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.
The following tumor types are included in this study:
Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.
Eligibility Criteria
Inclusion Criteria:
For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4.
For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC
Progressed, or been intolerant to, at least one standard treatment regimen, except for participants in 1st line cohorts.
ECOG performance status between 0 and 2
At least 1 lesion with measurable disease at baseline
Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy)
Exclusion Criteria:
Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease
Autoimmune disease
Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
Uncontrolled CNS metastases
Other protocol defined inclusion/exclusion criteria could apply
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There are 53 Locations for this study
La Jolla California, 92093, United States
Aurora Colorado, 80045, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60637, United States
Niles Illinois, 60714, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
New York New York, 10065, United States
Portland Oregon, 97213, United States
Allentown Pennsylvania, 18103, United States
Pittsburgh Pennsylvania, 15232, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
North Sydney New South Wales, 2060, Australia
Greenslopes Queensland, 4120, Australia
Southport Queensland, 4215, Australia
Melbourne Victoria, 3000, Australia
Nedlands Western Australia, 6009, Australia
Wien , 1090, Austria
Wien , 1090, Austria
Toronto Ontario, M5G 2, Canada
Quebec City Quebec, G1J 1, Canada
Copenhagen , 2100, Denmark
Herlev , 2730, Denmark
Helsinki , 00290, Finland
Marseille Cedex 5 , 13385, France
Nantes Cedex 01 , 44093, France
Pierre Benite Cedex , 69495, France
Toulouse Cedex 9 , 31059, France
Villejuif , 94800, France
Essen , 45122, Germany
Heilbronn , 74078, Germany
Wuerzburg , 97080, Germany
Milano , 20141, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Nagoya-shi Aichi, 46685, Japan
Sapporo-shi Hokkaido, 06085, Japan
Sunto-gun Shizuoka, 41187, Japan
Chuo-ku Tokyo, 10400, Japan
Amsterdam , 1066 , Netherlands
Oslo , 0379, Norway
Barcelona , 08035, Spain
Malaga , 29010, Spain
Pamplona , 31008, Spain
Lausanne , 1011, Switzerland
Zuerich , 8091, Switzerland
London Greater London, NW1 2, United Kingdom
London Greater London, SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
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