Phase
Condition
Neoplasms
Treatment
BMS-986360
Docetaxel
Capecitabine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants in Part 1 must have histologic or cytologic confirmation of non-smallcell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamouscell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renalcell carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), orsarcoma, that is advanced (metastatic, recurrent, and/or unresectable) withmeasurable disease per RECIST v1.1. In Part 2, only participants with histologicconfirmation of advanced NSCLC or mTNBC with measurable disease per RECIST v1.1 areeligible.
In Part 2, archival biopsy collected within 3 months of screening with nointervening therapy (formalin-fixed, paraffin embedded [FFPE] blocks or a minimum of 20 freshly cut unstained FFPE slides with an associated pathological report) orfresh biopsy collection at Screening and fresh biopsy collection at cycle 3 day 1 (C3D1) (± 5 days) are mandatory, while it is strongly encouraged but optional atprogression. Therefore, the participant in Part 2 must have a suitable tumor lesionfor the biopsy procedure, as judged by the investigator, in order to be eligible forthe study.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Participants resistant/refractory to or intolerant of existing standard therapiesknown to provide clinical benefit (in addition, participants with NSCLC must beresistant or refractory to anti-PD-(L)1-based immunotherapy)
Exclusion
Exclusion Criteria:
Participants with primary central nervous system (CNS) disease, or tumors with CNSmetastases as the only disease site, will be excluded. Participants with controlledbrain metastases, however, will be allowed to enroll. Controlled brain metastasesare defined as no radiographic progression for at least 4 weeks following radiationand/or surgical treatment (or 4 weeks of observation if no intervention isclinically indicated), no longer taking steroids for at least 2 weeks prior to firstdose of study intervention, and with no new or progressive neurological signs andsymptoms.
Participants with a condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressivemedications within 30 days of randomization. Inhaled or topical steroids and adrenalreplacement steroid doses > 10 mg daily prednisone equivalent are permitted in theabsence of active autoimmune disease.
Participants with concurrent malignancy or history of prior malignancy active within 2 years (except history of early-stage basal/squamous cell skin cancer ornon-invasive or in situ cancers who have undergone definitive treatment) areexcluded unless treatment was completed at least 2 years before randomization andthe participant has no evidence of disease.
Participants with NSCLC with known or not tested for epidermal growth factorreceptor (EGFR) or V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600Emutations, or anaplastic lymphoma kinase (ALK) or receptor tyrosine kinase (ROS1)translocations sensitive to available targeted inhibitor therapy
Other protocol-defined inclusion/exclusion criteria apply.
Study Design
Connect with a study center
Hospital Británico de Buenos Aires
Ciudad autónoma de Buenos Aires, Buenos Aires 1280
ArgentinaActive - Recruiting
Local Institution - 0033
Ciudad autónoma de Buenos Aires, Buenos Aires 1280
ArgentinaSite Not Available
Local Institution - 0032
ABB, Ciudad Autónoma De Buenos Aires C1199ABB
ArgentinaSite Not Available
Clinica Adventista Belgrano
Caba, Ciudad Autónoma De Buenos Aires C1430EGF
ArgentinaActive - Recruiting
Local Institution - 0030
Caba, Ciudad Autónoma De Buenos Aires C1430EGF
ArgentinaSite Not Available
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, 1426
ArgentinaActive - Recruiting
Local Institution - 0031
Ciudad Autónoma de Buenos Aires, 1426
ArgentinaSite Not Available
Local Institution - 0010
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
St Vincent's Hospital - The Kinghorn Cancer Center
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
GenesisCare North Shore
St Leonards, New South Wales 2065
AustraliaActive - Recruiting
Local Institution - 0061
St Leonards, New South Wales 2065
AustraliaSite Not Available
Gallipoli Medical Research Foundation
Brisbane, Queensland 4120
AustraliaActive - Recruiting
Gallipoli Medical Research Ltd
Brisbane, Queensland 4120
AustraliaActive - Recruiting
Local Institution - 0008
Brisbane, Queensland 4120
AustraliaSite Not Available
Frankston Hospital
Frankston, Victoria 3199
AustraliaActive - Recruiting
Local Institution - 0063
Frankston, Victoria 3199
AustraliaSite Not Available
Local Institution - 0062
Heidelberg, Victoria 3084
AustraliaSite Not Available
Local Institution - 0003
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
The Ottawa Hospital - General Campus
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
Local Institution - 0005
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Princess Margaret Cancer Centre
Toronto, Ontario M5G1Z5
CanadaActive - Recruiting
Bradfordhill
Santiago, Región Metropolitana De Santiago 8420383
ChileActive - Recruiting
FALP
Santiago, Región Metropolitana De Santiago 7500921
ChileActive - Recruiting
Fundacion Arturo Lopez Perez (FALP)
Santiago, Región Metropolitana De Santiago 7500921
ChileActive - Recruiting
Local Institution - 0034
Santiago, Región Metropolitana De Santiago 8420383
ChileSite Not Available
Local Institution - 0035
Santiago, Región Metropolitana De Santiago 8330032
ChileSite Not Available
Local Institution - 0047
Santiago, Región Metropolitana De Santiago 7500921
ChileSite Not Available
Pontificia Universidad Catolica de Chile
Santiago, Región Metropolitana De Santiago 8330032
ChileActive - Recruiting
Institut Paoli-Calmettes
Marseille, Provence-Alpes-Côte-d'Azur 13273
FranceActive - Recruiting
Local Institution - 0049
Marseille, Provence-Alpes-Côte-d'Azur 13273
FranceSite Not Available
Gustave Roussy
Villejuif, Val-de-Marne 94800
FranceActive - Recruiting
Local Institution - 0052
Villejuif, Val-de-Marne 94800
FranceSite Not Available
Institut Curie
Paris, 75248
FranceActive - Recruiting
Local Institution - 0048
Paris, 75248
FranceSite Not Available
Institut Claudius Regaud
Toulouse, 31059
FranceActive - Recruiting
Local Institution - 0050
Toulouse, 31059
FranceSite Not Available
Humanitas
Rozzano, Milano 20089
ItalyActive - Recruiting
Local Institution - 0057
Rozzano, Milano 20089
ItalySite Not Available
Local Institution - 0058
Rome, Roma 00144
ItalySite Not Available
Istituto di Candiolo
Candiolo, Torino 10060
ItalyActive - Recruiting
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino 10060
ItalyActive - Recruiting
Local Institution - 0059
Candiolo, Torino 10060
ItalySite Not Available
Istituto Oncologico Veneto IRCCS
Padova, 35128
ItalyActive - Recruiting
Local Institution - 0065
Padova, 35128
ItalySite Not Available
Local Institution - 0036
Mexico City, Distrito Federal 14080
MexicoSite Not Available
Local Institution - 0038
Mexico City, Distrito Federal 03100
MexicoSite Not Available
Local Institution - 0041
Zapopan, Jalisco 45070
MexicoSite Not Available
Local Institution - 0039
Monterrey, Nuevo León 66460
MexicoSite Not Available
Local Institution - 0037
Puebla, 72424
MexicoSite Not Available
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña] 08036
SpainActive - Recruiting
Local Institution - 0053
Barcelona, Catalunya [Cataluña] 08036
SpainSite Not Available
Local Institution - 0054
Pozuelo de Alarcon, Madrid 28223
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad De 28041
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad De 28034
SpainActive - Recruiting
Local Institution - 0055
Madrid, Madrid, Comunidad De 28034
SpainSite Not Available
Local Institution - 0056
Madrid, Madrid, Comunidad De 28041
SpainSite Not Available
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainActive - Recruiting
Local Institution - 0064
Sevilla, 41013
SpainSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Local Institution - 0019
Los Angeles, California 90048
United StatesSite Not Available
Local Institution - 0029
Los Angeles, California 90025
United StatesSite Not Available
Local Institution - 0051
Los Angeles, California 90067
United StatesSite Not Available
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California 90025
United StatesActive - Recruiting
Valkyrie Clinical Trials
Los Angeles, California 90067
United StatesActive - Recruiting
Yale University School of Medicine
New Haven, Connecticut 06510
United StatesSite Not Available
Local Institution - 0067
Honolulu, Hawaii 96813
United StatesSite Not Available
University of Hawaii Cancer Center
Honolulu, Hawaii 96813
United StatesSite Not Available
Local Institution - 0026
New Orleans, Louisiana 70121
United StatesSite Not Available
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesActive - Recruiting
Ochsner Medical Center - Jefferson Highway
New Orleans, Louisiana 70121
United StatesSite Not Available
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Local Institution - 0001
Hackensack, New Jersey 07601
United StatesSite Not Available
Carolina BioOncology Institute
Huntersville, North Carolina 28078
United StatesActive - Recruiting
Local Institution - 0018
Huntersville, North Carolina 28078
United StatesSite Not Available
Local Institution - 0028
Nashville, Tennessee 37203
United StatesSite Not Available
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
Tennessee Oncology Nashville
Nashville, Tennessee 37203
United StatesActive - Recruiting
Local Institution - 0027
San Antonio, Texas 78229
United StatesSite Not Available
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas 78229
United StatesActive - Recruiting
Local Institution - 0046
West Valley City, Utah 84119
United StatesSite Not Available
START Mountain Region
West Valley City, Utah 84119
United StatesActive - Recruiting
NEXT Virginia
Fairfax, Virginia 22031
United StatesSite Not Available
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