Program Status
RecruitingPhase
Phase 1 Phase 2Prior Immunotherapy Allowed
YesCRC-directed Trial
YesDrugs
BMS-936558-01, BMS-986340Tags
MSI-H/ MMRd, MSS/ MMRpComments
BMS-986340 (anti-CCR8 monoclonal antibody) monotherapy and later in combination with nivolumab (anti PD-1, immunotherapy)
| Location | Location Status |
|---|---|
| United States | |
|
Community Cancer Institute Clovis, California 93611 |
Recruiting |
|
USC/Norris Comprehensive Cancer Center Los Angeles, California 90033 |
Recruiting |
|
Hoag Memorial Hospital Presbyterian Newport Beach, California 92663 |
Recruiting |
|
University of Iowa Iowa City, Iowa 52242 |
Recruiting |
|
John Theurer Cancer Center Hackensack, New Jersey 07601 |
Recruiting |
|
Columbia University Irving Medical Center New York, New York 10032 |
Recruiting |
|
Local Institution - 0002 New York, New York 10065 |
Completed |
|
Providence Cancer Center Oncology and Hematology Care- Eastside Portland, Oregon 97213 |
Recruiting |
|
Local Institution - 0063 Nashville, Tennessee 37067 |
Not yet recruiting |
|
Vanderbilt University Medical Center Nashville, Tennessee 37232 |
Recruiting |
|
Houston Methodist Hospital Houston, Texas 77030 |
Recruiting |
| Australia | |
|
Blacktown Hospital Blacktown, New South Wales 2148 |
Recruiting |
|
Liverpool Hospital Liverpool, New South Wales 2170 |
Recruiting |
|
Princess Alexandra Hospital Brisbane, Queensland 4102 |
Recruiting |
|
Cabrini Hospital - Malvern Malvern, Victoria 3144 |
Recruiting |
|
St Vincent's Hospital Melbourne, Victoria 3065 |
Recruiting |
|
One Clinical Research Nedlands, Western Australia 6009 |
Recruiting |
| Canada | |
|
Cross Cancer Institute Edmonton, Alberta T6X 1E8 |
Recruiting |
|
BC Cancer Vancouver Vancouver, British Columbia V5Z 4E6 |
Recruiting |
|
Hamilton Health Sciences-Juravinski Cancer Centre Hamilton, Ontario L8V5C2 |
Recruiting |
|
Local Institution - 0009 Toronto, Ontario M5G 2M9 |
Completed |
|
Centre Hospitalier de luniversite de Montreal Montreal, Quebec H2X 0A9 |
Recruiting |
|
The Ottawa Hospital Cancer Centre Ottawa K1H 8L6 |
Recruiting |
| Germany | |
|
Universitaetsklinikum Ulm Ulm, Baden-Wurttemberg 89081 |
Recruiting |
|
Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit Dresden 01307 |
Recruiting |
|
Universitaetsklinikum Essen Essen 45147 |
Recruiting |
|
Universitatsklinikum Frankfurt Frankfurt 60590 |
Recruiting |
|
Universitaetsklinikum Wuerzburg Wuerzburg 97078 |
Recruiting |
| Israel | |
|
Rabin Medical Center Petah Tikva, HaMerkaz 4941492 |
Recruiting |
|
Local Institution - 0035 Ramat Gan, HaMerkaz 5265601 |
Withdrawn |
|
Sheba Medical Center Ramat Gan, HaMerkaz 5265601 |
Recruiting |
|
Rambam Health Care Campus Haifa, HaTsafon 3109601 |
Recruiting |
|
Sourasky Medical Center Tel Aviv, Tell Abīb 6423906 |
Recruiting |
| Italy | |
|
Humanitas Rozzano, Milano 20089 |
Recruiting |
|
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia Candiolo, Torino 10060 |
Recruiting |
|
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 Milan 20133 |
Recruiting |
|
Istituto Nazionale Tumori IRCCS Fondazione Pascale Napoli 80131 |
Recruiting |
|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Universita Cattolica del Sacro Cuore Roma 00168 |
Recruiting |
|
ospedale le scotte-U.O.C. Immunoterapia Oncologica Siena 53100 |
Recruiting |
| Japan | |
|
National Cancer Center Hospital East Kashiwa, Chiba 277-8577 |
Recruiting |
| Spain | |
|
Hospital Universitario Virgen de la Victoria Málaga, Andalucía 29010 |
Recruiting |
|
Institut Catalan d Oncologia (ICO) - Badalona Badalona, Barcelona [Barcelona] 08916 |
Recruiting |
|
Hospital Universitari Vall d'Hebron Barcelona, Barcelona [Barcelona] 08035 |
Recruiting |
|
Hospital Universitario 12 de Octubre Madrid, Madrid, Comunidad De 28041 |
Recruiting |
|
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD Madrid 28040 |
Recruiting |
|
Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC Madrid 28050 |
Recruiting |
|
Clinica Universidad de Navarra-oNCOLOGY Pamplona 31008 |
Recruiting |
Contacts
CONTACT
855-907-3286 Clinical.Trials@bms.com
CONTACT
Inclusion Criteria
Inclusion Criteria:
* Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Radiographically documented progressive disease on or after the most recent therapy
* Received standard-of-care therapies, (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
* Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant
Exclusion Criteria
Exclusion Criteria:
* Women who are pregnant or breastfeeding
* Primary central nervous system (CNS) malignancy
* Untreated CNS metastases
* Leptomeningeal metastases
* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
* Active, known, or suspected autoimmune disease
* Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
* Prior organ or tissue allograft
* Uncontrolled or significant cardiovascular disease
* Major surgery within 4 weeks of study drug administration
* History of or with active interstitial lung disease or pulmonary fibrosis
Other protocol-defined inclusion/exclusion criteria apply
