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.

View Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

1499

Study ID:

NCT01968109

Recruitment Status:

Active, not recruiting

Sponsor:

Bristol-Myers Squibb

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There are 53 Locations for this study

See Locations Near You

Local Institution - 0043
La Jolla California, 92093, United States
Local Institution - 0053
Aurora Colorado, 80045, United States
Local Institution - 0058
Tampa Florida, 33612, United States
Local Institution - 0003
Chicago Illinois, 60637, United States
Local Institution - 0048
Niles Illinois, 60714, United States
Local Institution - 0004
Baltimore Maryland, 21287, United States
Local Institution - 0001
Boston Massachusetts, 02215, United States
Local Institution - 0011
Detroit Michigan, 48201, United States
Local Institution - 0051
Rochester Minnesota, 55905, United States
Local Institution - 0044
Saint Louis Missouri, 63110, United States
Local Institution - 0005
New York New York, 10065, United States
Local Institution - 0002
Portland Oregon, 97213, United States
Local Institution - 0047
Allentown Pennsylvania, 18103, United States
Local Institution - 0010
Pittsburgh Pennsylvania, 15232, United States
Local Institution - 0057
Dallas Texas, 75246, United States
Local Institution - 0045
Houston Texas, 77030, United States
Local Institution - 0008
Seattle Washington, 98109, United States
Local Institution - 0029
North Sydney New South Wales, 2060, Australia
Local Institution - 0031
Brisbane Queensland, 4120, Australia
Local Institution - 0039
Southport Queensland, 4215, Australia
Local Institution - 0033
Melbourne Victoria, 3000, Australia
Local Institution - 0032
Nedlands Western Australia, 6009, Australia
Local Institution - 0023
Wien , 1090, Austria
Local Institution - 0024
Wien , 1090, Austria
Local Institution - 0049
Toronto Ontario, M5G 2, Canada
Local Institution - 0050
Quebec City Quebec, G1J 1, Canada
Local Institution - 0028
Copenhagen , 2100, Denmark
Local Institution - 0020
Herlev , 2730, Denmark
Local Institution - 0021
Helsinki Uusimaa, 00290, Finland
Local Institution - 0038
Marseille Cedex 5 , 13385, France
Local Institution - 0037
Nantes Cedex 01 , 44093, France
Local Institution - 0036
Pierre Benite Cedex , 69495, France
Local Institution - 0026
Toulouse Cedex 9 , 31059, France
Local Institution - 0018
Villejuif , 94800, France
Local Institution - 0007
Essen , 45122, Germany
Local Institution - 0040
Heilbronn , 74078, Germany
Local Institution - 0041
Wuerzburg , 97080, Germany
Local Institution - 0014
Milano , 20141, Italy
Local Institution - 0013
Napoli , 80131, Italy
Local Institution - 0035
Padova , 35128, Italy
Local Institution - 0055
Nagoya-shi Aichi, 46685, Japan
Local Institution - 0059
Sapporo-shi Hokkaido, 06085, Japan
Local Institution - 0054
Sunto-gun Shizuoka, 41187, Japan
Local Institution - 0052
Chuo-ku Tokyo, 10400, Japan
Local Institution - 0025
Amsterdam , 1066 , Netherlands
Local Institution - 0019
Oslo , 0379, Norway
Local Institution - 0015
Barcelona , 08035, Spain
Local Institution - 0046
Malaga , 29010, Spain
Local Institution - 0006
Pamplona , 31008, Spain
Local Institution - 0017
Lausanne , 1011, Switzerland
Local Institution - 0016
Zuerich , 8091, Switzerland
Local Institution - 0027
London Greater London, NW1 2, United Kingdom
Local Institution - 0022
London Greater London, SW3 6, United Kingdom
Local Institution - 0034
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

1499

Study ID:

NCT01968109

Recruitment Status:

Active, not recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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