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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
Date last updated
21/10/2024

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
Stopped early
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
Actual
12/09/2024
Sample size
Target
Accrual to date
Final
36
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
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.
Trial website
https://clinicaltrials.gov/study/NCT05543629
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05543629