Back to resultsA Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer
Primary Purpose
Advanced Solid Tumors, Non-small Cell Lung Cancer
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-986442
Nivolumab
Docetaxel
Carboplatin
Pemexetred
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumors focused on measuring BMS-986442, Nivolumab, Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have a life expectancy of at least 3 months at the time of first dose.
Exclusion Criteria:
- Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
- Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.
- Participants with an active, known, or suspected autoimmune disease.
Other protocol-defined inclusion/exclusion criteria apply.
Sites / Locations
- Mayo Clinic in Arizona - Phoenix
- University of California, Irvine (UCI) Health Cancer Center - Newport/Costa Mesa
- University of California, Irvine (UCI) Health - UC Irvine Medical Center
- Georgetown University Medical Center
- University of Miami Sylvester Comprehensive Cancer Center - Aventura
- Mayo Clinic in Florida
- AdventHealth Orlando
- Fort Wayne Medical Oncology and HematologyRecruiting
- Ochsner Clinic FoundationRecruiting
- START MidwestRecruiting
- Mayo Clinic in Rochester, Minnesota
- John Theurer Cancer Center at Hackensack University Medical CenterRecruiting
- Carolina BioOncology InstituteRecruiting
- University of Cincinnati Medical CenterRecruiting
- Lehigh Valley Health NetworkRecruiting
- University of Texas MD Anderson Cancer CenterRecruiting
- Local Institution - 0018Recruiting
- Local Institution - 0001Recruiting
- Local Institution - 0086
- Local Institution - 0002Recruiting
- Local Institution - 0084
- Local Institution - 0065
- Local Institution - 0064
- Local Institution - 0077
- Istituto Nazionale Tumori IRCCS Fondazione Pascale
- Local Institution - 0067
- Local Institution - 0073
- Local Institution - 0069
- Local Institution - 0068
- Local Institution - 0080
- Local Institution - 0083
- Local Institution - 0079
- Local Institution - 0082
- Local Institution - 0087
- Local Institution - 0081
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Part A: BMS-986442 + Nivolumab
Part B1: BMS-986442 + Nivolumab
Part B2: BMS-986442 + Nivolumab
Part C: BMS-986442 + Nivolumab + Docetaxel
Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed
Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel
Arm Description
Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)
Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)
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
Maximum observed plasma concentration (Cmax)
Time of maximum observed concentration (Tmax)
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Incidence of Anti-drug Antibodies (ADAs) to BMS-986442
Objective Response Rate (ORR)
Duration of Response (DOR)
Disease Control Rate (DCR)
Progression-free Survival Rate (PFSR)
Full Information
NCT ID
NCT05543629
First Posted
September 14, 2022
Last Updated
October 16, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT05543629
Brief Title
A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer
Official Title
A Phase 1b/2 Study of BMS-986442 in Combination With Nivolumab or Nivolumab and Chemotherapies in Participants With Advanced Solid Tumors and Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2022 (Actual)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 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 evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Non-small Cell Lung Cancer
Keywords
BMS-986442, Nivolumab, Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part A: BMS-986442 + Nivolumab
Arm Type
Experimental
Arm Title
Part B1: BMS-986442 + Nivolumab
Arm Type
Experimental
Arm Description
Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)
Arm Title
Part B2: BMS-986442 + Nivolumab
Arm Type
Experimental
Arm Description
Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)
Arm Title
Part C: BMS-986442 + Nivolumab + Docetaxel
Arm Type
Experimental
Arm Title
Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed
Arm Type
Experimental
Arm Title
Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
BMS-986442
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxane / Toxotere chemotherapy
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Platinum chemotherapy
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Pemexetred
Other Intervention Name(s)
Folate analog metabolic inhibitor
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxane chemotherapy
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to 119 Weeks
Title
Incidence of Serious Adverse Events (SAEs)
Time Frame
Up to 119 Weeks
Title
Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria
Time Frame
Up to 119 Weeks
Title
Incidence of AEs leading to discontinuation
Time Frame
Up to 119 Weeks
Title
Incidence of AEs leading to death
Time Frame
Up to 119 Weeks
Secondary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to 119 Weeks
Title
Time of maximum observed concentration (Tmax)
Time Frame
Up to 119 Weeks
Title
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Time Frame
Up to 119 Weeks
Title
Incidence of Anti-drug Antibodies (ADAs) to BMS-986442
Time Frame
Up to 119 Weeks
Title
Objective Response Rate (ORR)
Time Frame
At 6 months and 12 months
Title
Duration of Response (DOR)
Time Frame
At 6 months and 12 months
Title
Disease Control Rate (DCR)
Time Frame
At 6 months and 12 months
Title
Progression-free Survival Rate (PFSR)
Time Frame
At 6 months and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Participants must have a life expectancy of at least 3 months at the time of first dose.
Exclusion Criteria:
Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.
Participants with an active, known, or suspected autoimmune disease.
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 the 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
Mayo Clinic in Arizona - Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panayiotis Savvides, Site 0089
Phone
602-406-8222
Facility Name
University of California, Irvine (UCI) Health Cancer Center - Newport/Costa Mesa
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farshid Dayyani, Site 0096
Phone
714-456-5153
Facility Name
University of California, Irvine (UCI) Health - UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farshid Dayyani, Site 0075
Phone
714-456-5153
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Aventura
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelamari Rodriguez, Site 0053
Phone
305-689-4033
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Yan Lou, Site 0048
Phone
713-878-8182
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarek Mekhail, Site 0027
Phone
407-303-2024
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Babu, Site 0029
Phone
260-436-0800
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Johnson, Site 0022
Phone
504-842-3910
Facility Name
START Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish Sharma, Site 0005
Phone
616-600-3810
Facility Name
Mayo Clinic in Rochester, Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaushal Parikh, Site 0088
Phone
551-996-0760
Facility Name
John Theurer Cancer Center at Hackensack University Medical 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 0003
Phone
551-996-5863
Facility Name
Carolina BioOncology Institute
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Powderly, Site 0006
Phone
704-654-0485
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trisha Wise-Draper, Site 0019
Phone
513-558-2628
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Rizvi, Site 0046
Phone
610-402-7880
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maura Gillison, Site 0016
Phone
443-739-7611
Facility Name
Local Institution - 0018
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0001
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
Facility Name
Local Institution - 0086
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0086
Facility Name
Local Institution - 0002
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0002
Facility Name
Local Institution - 0084
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0084
Facility Name
Local Institution - 0065
City
Milan
State/Province
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0065
Facility Name
Local Institution - 0064
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0064
Facility Name
Local Institution - 0077
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0077
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Ascierto, Site 0062
Phone
390815903431
Facility Name
Local Institution - 0067
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0067
Facility Name
Local Institution - 0073
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0073
Facility Name
Local Institution - 0069
City
Bydgoszcz
ZIP/Postal Code
85796
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0069
Facility Name
Local Institution - 0068
City
Łódź
State/Province
Łódzkie
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0068
Facility Name
Local Institution - 0080
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0080
Facility Name
Local Institution - 0083
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0083
Facility Name
Local Institution - 0079
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0079
Facility Name
Local Institution - 0082
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0082
Facility Name
Local Institution - 0087
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0087
Facility Name
Local Institution - 0081
City
València
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0081
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/us/en/home.html
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer
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