Trial Title:
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
NCT ID:
NCT06618287
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Pembrolizumab
Osimertinib
Conditions: Keywords:
Non-Small Cell Lung Cancer (NSCLC)
Epidermal Growth Factor Receptor mutated (EGFRmt)
Epidermal Growth Factor Receptor wild-type (EGFRwt)
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BMS-986507
Description:
Specified dose on specified days
Arm group label:
Group A
Arm group label:
Group B
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
Specified dose on specified days
Arm group label:
Group A
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Specified dose on specified days
Arm group label:
Group B
Summary:
The purpose of this study is to evaluate the safety, tolerability, drug levels, and
preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid
tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria
- Participants must have at least one measurable lesion per response evaluation
criteria in solid tumors.
- Participants must have an Eastern Cooperative Oncology Group Performance Status of 0
or 1.
- Participants must have a life expectancy of at least 3 months at the time of the
first dose.
Exclusion Criteria
- Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small
Cell Lung Cancer (NSCLC) histology.
- Participants must not have any untreated symptomatic central nervous system (CNS)
metastases.
- Participants must not have a history of serious recurrent infections.
- Participants must not have a history of severe heart disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Local Institution - 0009
Address:
City:
Miami
Zip:
33136
Country:
United States
Contact:
Last name:
Site 0009
Facility:
Name:
Local Institution - 0010
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Contact:
Last name:
Site 0010
Facility:
Name:
Local Institution - 0029
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Contact:
Last name:
Site 0029
Facility:
Name:
Local Institution - 0014
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Facility:
Name:
Local Institution - 0012
Address:
City:
Seattle
Zip:
98104
Country:
United States
Contact:
Last name:
Site 0012
Facility:
Name:
Local Institution - 0027
Address:
City:
Liverpool
Zip:
2170
Country:
Australia
Contact:
Last name:
Site 0027
Facility:
Name:
Local Institution - 0028
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Contact:
Last name:
Site 0028
Facility:
Name:
Local Institution - 0024
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Contact:
Last name:
Site 0024
Facility:
Name:
Local Institution - 0023
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Facility:
Name:
Local Institution - 0026
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Contact:
Last name:
Site 0026
Facility:
Name:
Local Institution - 0025
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Contact:
Last name:
Site 0025
Facility:
Name:
Local Institution - 0022
Address:
City:
Montréal
Zip:
H2X 0A9
Country:
Canada
Contact:
Last name:
Site 0022
Facility:
Name:
Local Institution - 0004
Address:
City:
Leiden
Zip:
2333 ZA
Country:
Netherlands
Contact:
Last name:
Site 0004
Facility:
Name:
Local Institution - 0003
Address:
City:
Amsterdam
Zip:
1066 CX
Country:
Netherlands
Contact:
Last name:
Site 0003
Facility:
Name:
Local Institution - 0016
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Contact:
Last name:
Site 0016
Facility:
Name:
Local Institution - 0018
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Contact:
Last name:
Site 0018
Facility:
Name:
Local Institution - 0017
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Contact:
Last name:
Site 0017
Facility:
Name:
Local Institution - 0019
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Contact:
Last name:
Site 0019
Facility:
Name:
Local Institution - 0020
Address:
City:
Birmingham
Zip:
B15 2TH
Country:
United Kingdom
Contact:
Last name:
Site 0020
Facility:
Name:
Local Institution - 0021
Address:
City:
Glasgow
Zip:
G12 0YN
Country:
United Kingdom
Contact:
Last name:
Site 0021
Facility:
Name:
Local Institution - 0001
Address:
City:
Newcastle upon Tyne
Zip:
NE7 7DN
Country:
United Kingdom
Contact:
Last name:
Site 0001
Start date:
November 25, 2024
Completion date:
December 23, 2027
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06618287
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06618287.html
