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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05543629




Registration number
NCT05543629
Ethics application status
Date submitted
14/09/2022
Date registered
16/09/2022

Titles & IDs
Public title
A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
2022-501676-26
Secondary ID [2] 0 0
CA115-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BMS-986442
Treatment: Other - Nivolumab
Treatment: Drugs - Docetaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemexetred
Treatment: Drugs - Paclitaxel

Experimental: Part A: BMS-986442 + Nivolumab -

Experimental: Part B1: BMS-986442 + Nivolumab - Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)

Experimental: Part B2: BMS-986442 + Nivolumab - Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)

Experimental: Part C: BMS-986442 + Nivolumab + Docetaxel -

Experimental: Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed -

Experimental: Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel -


Treatment: Other: BMS-986442
Specified dose on specified days

Treatment: Other: Nivolumab
Specified dose on specified days

Treatment: Drugs: Docetaxel
Specified dose on specified days

Treatment: Drugs: Carboplatin
Specified dose on specified days

Treatment: Drugs: Pemexetred
Specified dose on specified days

Treatment: Drugs: Paclitaxel
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs)
Timepoint [1] 0 0
Up to 119 Weeks
Primary outcome [2] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to 119 Weeks
Primary outcome [3] 0 0
Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria
Timepoint [3] 0 0
Up to 119 Weeks
Primary outcome [4] 0 0
Incidence of AEs leading to discontinuation
Timepoint [4] 0 0
Up to 119 Weeks
Primary outcome [5] 0 0
Incidence of AEs leading to death
Timepoint [5] 0 0
Up to 119 Weeks
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [1] 0 0
Up to 119 Weeks
Secondary outcome [2] 0 0
Time of maximum observed concentration (Tmax)
Timepoint [2] 0 0
Up to 119 Weeks
Secondary outcome [3] 0 0
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Timepoint [3] 0 0
Up to 119 Weeks
Secondary outcome [4] 0 0
Incidence of Anti-drug Antibodies (ADAs) to BMS-986442
Timepoint [4] 0 0
Up to 119 Weeks
Secondary outcome [5] 0 0
Objective Response Rate (ORR)
Timepoint [5] 0 0
At 6 months and 12 months
Secondary outcome [6] 0 0
Duration of Response (DOR)
Timepoint [6] 0 0
At 6 months and 12 months
Secondary outcome [7] 0 0
Disease Control Rate (DCR)
Timepoint [7] 0 0
At 6 months and 12 months
Secondary outcome [8] 0 0
Progression-free Survival Rate (PFSR)
Timepoint [8] 0 0
At 6 months and 12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/09/2024
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0018 - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - 0001 - Westmead
Recruitment hospital [3] 0 0
Local Institution - 0086 - Southport
Recruitment hospital [4] 0 0
Local Institution - 0002 - Clayton
Recruitment hospital [5] 0 0
Local Institution - 0084 - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Italy
State/province [13] 0 0
Milano
Country [14] 0 0
Italy
State/province [14] 0 0
Torino
Country [15] 0 0
Italy
State/province [15] 0 0
Toscana
Country [16] 0 0
Italy
State/province [16] 0 0
Napoli
Country [17] 0 0
Poland
State/province [17] 0 0
Mazowieckie
Country [18] 0 0
Poland
State/province [18] 0 0
Pomorskie
Country [19] 0 0
Poland
State/province [19] 0 0
Bydgoszcz
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona [Barcelona]
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid, Comunidad De
Country [22] 0 0
Spain
State/province [22] 0 0
Málaga
Country [23] 0 0
Spain
State/province [23] 0 0
Sevilla
Country [24] 0 0
Spain
State/province [24] 0 0
València

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05543629