arrow copy Created with Sketch. FightCRC Logo fcc-logo-light
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

Program Status

Active, not recruiting

Phase

Phase 1 Phase 2

Immunotherapy-centered Trial

No

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Drugs

BMS-986213, Nivolumab, Relatlimab, Opdivo

Tags

MSS/ MMRp

Comments

Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, Opdivo, BMS-936558)

Location Location Status
United States
Local Institution - 0043
La Jolla, California 92093-0698
Active, not recruiting
Local Institution - 0053
Aurora, Colorado 80045
Active, not recruiting
Local Institution - 0058
Tampa, Florida 33612
Active, not recruiting
Local Institution - 0003
Chicago, Illinois 60637
Active, not recruiting
Local Institution - 0048
Niles, Illinois 60714
Active, not recruiting
Local Institution - 0004
Baltimore, Maryland 21287
Active, not recruiting
Local Institution - 0001
Boston, Massachusetts 02215
Active, not recruiting
Local Institution - 0011
Detroit, Michigan 48201
Active, not recruiting
Local Institution - 0051
Rochester, Minnesota 55905-0001
Active, not recruiting
Local Institution - 0044
Saint Louis, Missouri 63110
Active, not recruiting
Local Institution - 0005
New York, New York 10065
Active, not recruiting
Local Institution - 0002
Portland, Oregon 97213
Active, not recruiting
Local Institution - 0047
Allentown, Pennsylvania 18103
Active, not recruiting
Local Institution - 0010
Pittsburgh, Pennsylvania 15232-1305
Active, not recruiting
Local Institution - 0057
Dallas, Texas 75246
Active, not recruiting
Local Institution - 0045
Houston, Texas 77030
Active, not recruiting
Local Institution - 0008
Seattle, Washington 98109
Active, not recruiting
Australia
Local Institution - 0029
North Sydney, New South Wales 2060
Active, not recruiting
Local Institution - 0031
Brisbane, Queensland 4120
Active, not recruiting
Local Institution - 0039
Southport, Queensland 4215
Active, not recruiting
Local Institution - 0033
Melbourne, Victoria 3000
Active, not recruiting
Local Institution - 0032
Nedlands, Western Australia 6009
Active, not recruiting
Austria
Local Institution - 0023
Wien 1090
Active, not recruiting
Local Institution - 0024
Wien 1090
Active, not recruiting
Canada
Local Institution - 0049
Toronto, Ontario M5G 2M9
Active, not recruiting
Local Institution - 0050
Quebec City, Quebec G1J 1Z4
Active, not recruiting
Denmark
Local Institution - 0028
Copenhagen 2100
Active, not recruiting
Local Institution - 0020
Herlev 2730
Active, not recruiting
Finland
Local Institution - 0021
Helsinki, Uusimaa 00290
Active, not recruiting
France
Local Institution - 0038
Marseille Cedex 5 13385
Active, not recruiting
Local Institution - 0037
Nantes Cedex 01 44093
Active, not recruiting
Local Institution - 0036
Pierre Benite Cedex 69495
Active, not recruiting
Local Institution - 0026
Toulouse Cedex 9 31059
Active, not recruiting
Local Institution - 0018
Villejuif 94800
Active, not recruiting
Germany
Local Institution - 0007
Essen 45122
Active, not recruiting
Local Institution - 0040
Heilbronn 74078
Active, not recruiting
Local Institution - 0041
Wuerzburg 97080
Active, not recruiting
Italy
Istituto Europeo Di Oncologia
Milano 20141
Active, not recruiting
Istituto Nazionale Tumori Fondazione Pascale
Napoli 80131
Active, not recruiting
Istituto Oncologico Veneto - I.R.C.C.S.
Padova 35128
Active, not recruiting
Japan
Local Institution - 0055
Nagoya-shi, Aichi 4668560
Active, not recruiting
Local Institution - 0059
Sapporo-shi, Hokkaido 0608543
Active, not recruiting
Local Institution - 0054
Sunto-gun, Shizuoka 4118777
Active, not recruiting
Local Institution - 0052
Chuo-ku, Tokyo 1040045
Active, not recruiting
Netherlands
Local Institution - 0025
Amsterdam 1066 CX
Active, not recruiting
Norway
Local Institution - 0019
Oslo 0379
Active, not recruiting
Spain
Local Institution - 0015
Barcelona 08035
Active, not recruiting
Local Institution - 0046
Malaga 29010
Active, not recruiting
Local Institution - 0006
Pamplona 31008
Active, not recruiting
Switzerland
Local Institution - 0017
Lausanne 1011
Active, not recruiting
Local Institution - 0016
Zuerich 8091
Active, not recruiting
United Kingdom
Local Institution - 0027
London, Greater London NW1 2PG
Active, not recruiting
Local Institution - 0022
London, Greater London SW3 6JJ
Active, not recruiting
Local Institution - 0034
Manchester M20 4BX
Active, not recruiting

Inclusion 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

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

NCT ID

NCT01968109

Date Trial Added

2013-10-23

Updated Date

2024-02-07