Back to resultsA Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Primary Purpose
Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-986340
BMS-936558-01
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring BMS-986340, Cervical Cancer, CRC, First-in-human, GEJ, Gastric/Gastroesophageal Junction Adenocarcinoma, HNSCC, Microsatellite Stable Colorectal Cancer, MSS CRC, Nivolumab, Non-Small-Cell Lung Cancer, NSCLC, SCCHN, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Urothelial Carcinoma, Pancreatic Adenocarcinoma, Melanoma, Ovarian Neoplasms, Triple Negative Breast Neoplasms
Eligibility 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
- 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, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
- Parts 1A, 1B, and 2A: Advanced or metastatic non-small cell lung cancer, squamous cell carcinoma of head and neck, microsatellite stable colorectal cancer, gastric/ gastroesophageal junction adenocarcinoma, or cervical cancer, 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:
- 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
Sites / Locations
- Community Cancer InstituteRecruiting
- USC/Norris Comprehensive Cancer Center
- Hoag Memorial Hospital Presbyterian
- University of Iowa
- John Theurer Cancer CenterRecruiting
- Columbia University Irving Medical CenterRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Providence Cancer Center Oncology and Hematology Care- EastsideRecruiting
- Vanderbilt Health One Hundred Oaks
- Vanderbilt University Medical Center
- Houston Methodist Hospital
- Local Institution - 0057Recruiting
- Local Institution - 0058Recruiting
- Local Institution - 0054Recruiting
- Local Institution - 0053Recruiting
- Local Institution - 0055Recruiting
- Local Institution - 0056
- Local Institution - 0027Recruiting
- Local Institution - 0030Recruiting
- Local Institution - 0029
- Local Institution - 0009Recruiting
- Local Institution - 0015Recruiting
- Local Institution - 0016Recruiting
- Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial UnitRecruiting
- Universitaetsklinikum EssenRecruiting
- Universitatsklinikum FrankfurtRecruiting
- Universitaetsklinikum Ulm
- Universitaetsklinikum WuerzburgRecruiting
- Local Institution - 0036Recruiting
- Local Institution - 0035
- Local Institution - 0038Recruiting
- Local Institution - 0039Recruiting
- Local Institution - 0037Recruiting
- HumanitasRecruiting
- Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'OncologiaRecruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1Recruiting
- Istituto Nazionale Tumori IRCCS Fondazione PascaleRecruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro CuoreRecruiting
- ospedale le scotte-U.O.C. Immunoterapia OncologicaRecruiting
- Local Institution - 0048Recruiting
- Local Institution - 0014Recruiting
- Local Institution - 0049Recruiting
- Local Institution - 0047Recruiting
- Local Institution - 0013Recruiting
- Local Institution - 0011Recruiting
- Local Institution - 0012Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part 1A: BMS-986340 Dose Escalation
Part 2A: BMS-986340 Dose Expansion
Part 1B: BMS-986340 + Nivolumab Dose Escalation
Part 2B: BMS-986340 + Nivolumab Dose Expansion
Part 1C: BMS-986340 + Docetaxel Dose Escalation
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAEs)
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Incidence of AEs leading to discontinuation
Incidence of AEs leading to death
Secondary Outcome Measures
Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)
PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)
PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))
PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau)
PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax)
PK parameters of BMS-986340 administered in combination with docetaxel: Cmax
PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax)
PK parameters of BMS-986340 administered in combination with docetaxel: Tmax
PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU)
PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau)
PK parameters of BMS-986340 administered in combination with docetaxel: Ctau
Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy
Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab
Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04895709
Brief Title
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Official Title
A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
April 10, 2025 (Anticipated)
Study Completion Date
September 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Gastric/Gastroesophageal Junction Adenocarcinoma, Microsatellite Stable Colorectal Cancer, Non-Small-Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Urothelial Carcinoma, Pancreatic Adenocarcinoma, Melanoma, Ovarian Neoplasms, Triple Negative Breast Neoplasms
Keywords
BMS-986340, Cervical Cancer, CRC, First-in-human, GEJ, Gastric/Gastroesophageal Junction Adenocarcinoma, HNSCC, Microsatellite Stable Colorectal Cancer, MSS CRC, Nivolumab, Non-Small-Cell Lung Cancer, NSCLC, SCCHN, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell, Urothelial Carcinoma, Pancreatic Adenocarcinoma, Melanoma, Ovarian Neoplasms, Triple Negative Breast Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
665 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part 1A: BMS-986340 Dose Escalation
Arm Type
Experimental
Arm Title
Part 2A: BMS-986340 Dose Expansion
Arm Type
Experimental
Arm Title
Part 1B: BMS-986340 + Nivolumab Dose Escalation
Arm Type
Experimental
Arm Title
Part 2B: BMS-986340 + Nivolumab Dose Expansion
Arm Type
Experimental
Arm Title
Part 1C: BMS-986340 + Docetaxel Dose Escalation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986340
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
BMS-936558-01
Other Intervention Name(s)
Nivolumab
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
Up to 120 weeks
Title
Incidence of serious adverse events (SAEs)
Time Frame
Up to 120 weeks
Title
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Time Frame
Up to 120 weeks
Title
Incidence of AEs leading to discontinuation
Time Frame
Up to 120 weeks
Title
Incidence of AEs leading to death
Time Frame
Up to 120 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)
Time Frame
Up to 120 weeks
Title
PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)
Time Frame
Up to 120 weeks
Title
PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))
Time Frame
Up to 120 weeks
Title
PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau)
Time Frame
Up to 120 weeks
Title
PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax)
Time Frame
Up to 120 weeks
Title
PK parameters of BMS-986340 administered in combination with docetaxel: Cmax
Time Frame
Up to 120 weeks
Title
PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax)
Time Frame
Up to 120 weeks
Title
PK parameters of BMS-986340 administered in combination with docetaxel: Tmax
Time Frame
Up to 120 weeks
Title
PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time Frame
Up to 120 weeks
Title
PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU)
Time Frame
Up to 120 weeks
Title
PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau)
Time Frame
Up to 120 weeks
Title
PK parameters of BMS-986340 administered in combination with docetaxel: Ctau
Time Frame
Up to 120 weeks
Title
Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy
Time Frame
Up to 120 weeks
Title
Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab
Time Frame
Up to 120 weeks
Title
Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel
Time Frame
Up to 120 weeks
Title
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Time Frame
At 6 months, 12 months
Title
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Time Frame
At 6 months, 12 months
Title
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Time Frame
At 6 months, 12 months
Title
Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
Time Frame
At 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Community Cancer Institute
City
Clovis
State/Province
California
ZIP/Postal Code
93611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uzair Chaudhary, Site 0032
Phone
559-387-1600
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony El-Khoueiry, Site 0041
Phone
323-865-3967
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Becerra, Site 0050
Phone
949-764-8222
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yousef Zakharia, Site 0062
Phone
319-384-8076
Facility Name
John Theurer Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Gutierrez, Site 0007
Phone
551-996-5863
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Moy, Site 0006
Phone
714-726-7966
Facility Name
Memorial Sloan Kettering Nassau
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Callahan, Site 0002
Phone
186-049-0095
Facility Name
Providence Cancer Center Oncology and Hematology Care- Eastside
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rom Leidner, Site 0001
Phone
503-215-5696
Facility Name
Vanderbilt Health One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Berlin, Site 0063
Phone
615-343-4967
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Berlin, Site 0052
Phone
615-343-4967
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maen Abdelrahim, Site 0061
Phone
346-241-5495
Facility Name
Local Institution - 0057
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0057
Facility Name
Local Institution - 0058
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0058
Facility Name
Local Institution - 0054
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0054
Facility Name
Local Institution - 0053
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0053
Facility Name
Local Institution - 0055
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0055
Facility Name
Local Institution - 0056
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0056
Facility Name
Local Institution - 0027
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6X 1E8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0027
Facility Name
Local Institution - 0030
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0030
Facility Name
Local Institution - 0029
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0029
Facility Name
Local Institution - 0009
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0009
Facility Name
Local Institution - 0015
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0016
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Wermke, Site 0010
Phone
+493514587566
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Kasper-Virchow, Site 0018
Phone
0049201 7233449
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Sebastian, Site 0020
Phone
+496963016217
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Laban, Site 0044
Phone
+4973150059548
Facility Name
Universitaetsklinikum Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97078
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrus Sayehli, Site 0019
Phone
4993120140964
Facility Name
Local Institution - 0036
City
Petah Tikva
State/Province
HaMerkaz
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0035
City
Ramat Gan
State/Province
HaMerkaz
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0038
City
Ramat Gan
State/Province
HaMerkaz
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0038
Facility Name
Local Institution - 0039
City
Haifa
State/Province
HaTsafon
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0037
City
Tel Aviv
State/Province
Tell Abīb
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0037
Facility Name
Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Simonelli, Site 0023
Phone
+390282244559
Facility Name
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanesa Gregorc, Site 0033
Phone
390119933250
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1
City
Milan
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filippo De Braud, Site 0024
Phone
390223903066
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Ascierto, Site 0034
Phone
390815903431
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gennaro Daniele, Site 0040
Phone
+39 06 3015 3446
Facility Name
ospedale le scotte-U.O.C. Immunoterapia Oncologica
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Maio, Site 0025
Phone
390577586335
Facility Name
Local Institution - 0048
City
Málaga
State/Province
Andalucía
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0048
Facility Name
Local Institution - 0014
City
Badalona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0049
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0049
Facility Name
Local Institution - 0047
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0047
Facility Name
Local Institution - 0013
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013
Facility Name
Local Institution - 0011
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution - 0012
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
URL
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
Learn more about this trial
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
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