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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
25/03/2025
Titles & IDs
Public title
A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer
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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
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Secondary ID [1]
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2022-501676-26
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Secondary ID [2]
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CA115-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
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Non-small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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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
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Treatment: Drugs: Carboplatin
Specified dose on specified days
Treatment: Drugs: Pemexetred
Specified dose on specified days
Treatment: Drugs: Paclitaxel
Specified dose on specified days
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events
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Assessment method [1]
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Number of Participants with Adverse Events. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. For the reporting of all AEs, including intensity or severity, on case report forms, please follow the definitions in National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
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Timepoint [1]
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From first dose to 100 days post last dose (Approximately 6 Months)
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Primary outcome [2]
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Number of Participants With Serious Adverse Events
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Assessment method [2]
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A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization
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Timepoint [2]
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From first dose to 100 days post last dose (Approximately 6 Months)
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Primary outcome [3]
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Number of Participants With Adverse Events Leading to Discontinuation
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Assessment method [3]
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Number of Participants with adverse events leading to discontinuation
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Timepoint [3]
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From first dose to 100 days post last dose (Approximately 6 Months)
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Primary outcome [4]
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Number of Participants With Dose Limiting Toxicities
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Assessment method [4]
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DLTs will be defined based on the incidence, intensity, and duration of the AEs for which no clear alternative cause is identified and will exclude events clearly related to disease progression or intercurrent illness. in addition, the following AEs will be DLTs: * Any death that is not clearly due to the underlying disease or extraneous causes * Any Grade = 3 non-hematological toxicity * Any Grade myocarditis * Any Grade myelitis, encephalitis, myasthenia gravis, or Guillain-Barre syndrome * Grade 4 neutropenia of \> 7 days duration * Grade 4 thrombocytopenia. * Grade 3 thrombocytopenia with clinically significant bleeding. * Febrile neutropenia Any AE that is not clearly due to disease progression or extraneous causes that occurs within the 28-day DLT evaluation window and meets criteria for permanent discontinuation will be considered a DLT.
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Timepoint [4]
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From Cycle 1 day 1 to day 28 (28 Days)
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Primary outcome [5]
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Number of Participants Who Died
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Assessment method [5]
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Number of Participants who died
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Timepoint [5]
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From first dose to 100 days post last dose (Approximately 6 Months)
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Secondary outcome [1]
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CMax
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Assessment method [1]
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Maximum observed serum concentration
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Timepoint [1]
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On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
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Secondary outcome [2]
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Tmax
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Assessment method [2]
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Time of maximum observed serum concentration
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Timepoint [2]
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On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
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Secondary outcome [3]
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AUC (Tau)
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Assessment method [3]
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Area under the serum concentration-time curve in 1 dosing interval
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Timepoint [3]
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On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)
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Secondary outcome [4]
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Number of Participants With BMS-986442 Anti Drug Antibody (ADA)
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Assessment method [4]
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Number of participants with BMS-986442 Anti Drug Antibody (ADA)
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Timepoint [4]
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From first dose to 100 days post last dose (Approximately 6 Months)
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Secondary outcome [5]
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Objective Response Rate (ORR) Per Recist v1.1 by Investigator
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Assessment method [5]
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ORR is defined as the number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by Investigator, according to RECIST v1.1 criteria, divided by the number of treated participants. The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a participant receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).
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Timepoint [5]
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From first dose to 100 days post last dose (Approximately 6 Months)
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Secondary outcome [6]
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Disease Control Rate (DCR) Per Recist v1.1 by Investigator
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Assessment method [6]
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Disease Control Rate (DCR) is defined as the number of treated participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD) (and/or SD \> 6 months), based on investigator assessments divided by the number of all treated participants.
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Timepoint [6]
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From first dose to 100 days post last dose (Approximately 6 Months)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/10/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/09/2024
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Sample size
Target
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Accrual to date
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Final
36
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0018 - Darlinghurst
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Recruitment hospital [2]
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Local Institution - 0001 - Westmead
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Recruitment hospital [3]
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Local Institution - 0086 - Southport
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Recruitment hospital [4]
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Local Institution - 0002 - Clayton
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Recruitment hospital [5]
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Local Institution - 0084 - Murdoch
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Indiana
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Country [5]
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United States of America
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State/province [5]
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Louisiana
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Country [6]
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United States of America
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State/province [6]
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Michigan
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Country [7]
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United States of America
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State/province [7]
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Minnesota
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Country [8]
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United States of America
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New Jersey
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Country [9]
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United States of America
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State/province [9]
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North Carolina
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Country [10]
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United States of America
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Ohio
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United States of America
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Pennsylvania
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United States of America
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Texas
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Country [13]
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Italy
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Milano
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Italy
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Torino
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Italy
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State/province [15]
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Toscana
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Italy
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State/province [16]
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Napoli
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Poland
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State/province [17]
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Mazowieckie
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Country [18]
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Poland
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State/province [18]
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Pomorskie
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Poland
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State/province [19]
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Bydgoszcz
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Country [20]
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Spain
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State/province [20]
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Barcelona [Barcelona]
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Country [21]
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Spain
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State/province [21]
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Madrid, Comunidad De
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Country [22]
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Spain
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State/province [22]
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Málaga
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Spain
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State/province [23]
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Sevilla
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Country [24]
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Spain
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State/province [24]
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València
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT05543629
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
See Plan Description
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Available to whom?
See Plan Description
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/29/NCT05543629/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/29/NCT05543629/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05543629
Download to PDF