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A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Program Status

Active, not recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

CRC-directed Trial

Drugs

BMS-986253, Ipilimumab, Nivolumab

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

BMS-986253: or HuMax®-IL8, or MDX 018.
”A human monoclonal antibody against the pro-inflammatory mediator interleukin-8 (IL-8; CXCL8), with potential antineoplastic activities. Upon administration, HuMax-IL8 directly binds to IL-8, thereby inhibiting the binding of IL-8 to its receptors CXCR1 and CXCR2. This inhibits activation of IL-8-mediated signaling transduction pathways, which decreases proliferation of susceptible tumor cells. Also, HuMax-IL8 effectively blocks binding of IL-8 to neutrophils and inhibits neutrophil activation and recruitment towards sites of inflammation, which reduces inflammation. IL-8, a member of the CXC chemokine family, is upregulated in a variety of cancer cell types and inflammatory diseases; it plays a key role in tumor cell proliferation, endothelial cell proliferation, and cancer stem cell (CSC) renewal.”

Location	Location Status
United States
Local Institution - 0059 Springdale, Arkansas 72762	Active, not recruiting
Local Institution - 0099 Los Angeles, California 90033	Active, not recruiting
Local Institution - 0007 Lakewood, Colorado 80228	Active, not recruiting
Local Institution - 0087 Atlanta, Georgia 30322	Active, not recruiting
Local Institution - 0100 Atlanta, Georgia 30342	Active, not recruiting
Local Institution - 0101 Marietta, Georgia 30060	Active, not recruiting
Local Institution - 0012 Columbia, Maryland 21044	Active, not recruiting
Local Institution - 0003 Lutherville, Maryland 21093	Active, not recruiting
Local Institution - 0060 Boston, Massachusetts 02215	Active, not recruiting
Local Institution - 0004 Ann Arbor, Michigan 48109	Active, not recruiting
Local Institution - 0076 Omaha, Nebraska 68130	Active, not recruiting
Comprehensive Cancer Centers Of Nevada Las Vegas, Nevada 89169	Active, not recruiting
Local Institution - 0005 Hackensack, New Jersey 07601	Active, not recruiting
Local Institution - 0032 New Brunswick, New Jersey 08903	Active, not recruiting
Local Institution - 0025 New York, New York 10029	Active, not recruiting
Local Institution - 0002 New York, New York 10032	Active, not recruiting
Local Institution - 0028 Oklahoma City, Oklahoma 73104	Active, not recruiting
Local Institution - 0017 Eugene, Oregon 97401	Active, not recruiting
Local Institution - 0001 Pittsburgh, Pennsylvania 15213	Active, not recruiting
Local Institution - 0009 Greenville, South Carolina 29615	Active, not recruiting
Local Institution - 0011 Austin, Texas 78705	Active, not recruiting
Local Institution - 0010 Dallas, Texas 75246	Active, not recruiting
Local Institution - 0014 Fort Worth, Texas 76104-3927	Active, not recruiting
Local Institution - 0018 Houston, Texas 77030	Active, not recruiting
Local Institution - 0006 San Antonio, Texas 78240	Active, not recruiting
Local Institution - 0013 Tyler, Texas 75702	Active, not recruiting
Local Institution - 0058 Salt Lake City, Utah 84112	Active, not recruiting
Local Institution - 0015 Fairfax, Virginia 22031	Active, not recruiting
Local Institution - 0008 Norfolk, Virginia 23502	Active, not recruiting
Australia
Local Institution - 0088 Wollstonecraft, New South Wales 2065	Active, not recruiting
Local Institution - 0096 Adelaide, South Australia 5000	Active, not recruiting
Local Institution - 0090 Melbourne, Victoria 3000	Active, not recruiting
Local Institution - 0095 Melbourne, Victoria 3004	Active, not recruiting
Local Institution - 0097 Perth, Western Australia 6009	Active, not recruiting
Local Institution - 0091 Ballarat Central VIC 3350	Active, not recruiting
Belgium
Local Institution - 0037 Bruxelles 1200	Active, not recruiting
Local Institution - 0036 Gent 9000	Active, not recruiting
Local Institution - 0082 Kortrijk 8500	Active, not recruiting
Canada
Local Institution - 0030 Edmonton, Alberta T6G 1Z2	Active, not recruiting
Local Institution - 0029 Vancouver, British Columbia V5Z 4E6	Active, not recruiting
Local Institution - 0078 Victoria, British Columbia V8R 6V5	Active, not recruiting
Local Institution - 0020 Toronto, Ontario M5G 1Z5	Active, not recruiting
Local Institution - 0055 Toronto, Ontario M5G 2M9	Active, not recruiting
Local Institution - 0056 Montréal, Quebec H2X 0A9	Active, not recruiting
France
Local Institution - 0067 Marseille, Bouches-du-Rhône 13385	Active, not recruiting
Local Institution - 0085 Nantes 44000	Active, not recruiting
Local Institution - 0068 Paris 75010	Active, not recruiting
Local Institution - 0102 Toulouse 31059	Active, not recruiting
Local Institution - 0069 Villejuif 94800	Active, not recruiting
Germany
Local Institution - 0054 Tübingen, Baden-Württemberg 72076	Active, not recruiting
Local Institution - 0052 Mainz, Rheinland-Pfalz 55131	Active, not recruiting
Local Institution - 0034 Berlin 12200	Active, not recruiting
Local Institution - 0053 Hamburg 20251	Active, not recruiting
Italy
Local Institution - 0043 Forlì 47014	Active, not recruiting
Local Institution - 0042 Milano 20132	Active, not recruiting
Local Institution - 0027 Napoli 80131	Active, not recruiting
Local Institution - 0026 Rozzano-milano 20089	Active, not recruiting
Poland
Local Institution - 0071 Krakow 31-115	Active, not recruiting
Local Institution - 0077 Warszawa 02-781	Active, not recruiting
Spain
Local Institution - 0045 Madrid 28034	Active, not recruiting
Local Institution - 0022 Madrid 28040	Active, not recruiting
Local Institution - 0023 Madrid 28050	Active, not recruiting
Local Institution - 0044 Malaga 29010	Active, not recruiting
Local Institution - 0021 Pamplona 31008	Active, not recruiting
Local Institution - 0047 Santiago de Compostela 15706	Active, not recruiting
Sweden
Local Institution - 0049 Lund 221 85	Active, not recruiting
Switzerland
Local Institution - 0040 Lausanne 1011	Active, not recruiting
Local Institution - 0041 St.Gallen 9007	Active, not recruiting
Local Institution - 0039 Zuerich 8091	Active, not recruiting
United Kingdom
Local Institution - 0024 Manchester, Greater Manchester M20 4BX	Active, not recruiting
Local Institution - 0083 Glasgow, Lanarkshire G12 0YN	Active, not recruiting
Local Institution - 0019 Birmingham, West Midlands B15 2TH	Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

* Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
* At least 1 lesion accessible for biopsy
* Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria

Exclusion Criteria:

* Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
* Participants with active, known or suspected autoimmune disease
* Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
* Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

Other protocol defined inclusion/exclusion criteria could apply

NCT ID

NCT03400332

Date Trial Added

2018-01-17

Updated Date

2024-07-17