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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06544655




Registration number
NCT06544655
Ethics application status
Date submitted
5/08/2024
Date registered
9/08/2024

Titles & IDs
Public title
A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
Scientific title
A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies
Secondary ID [1] 0 0
EU 2024-513696-40
Secondary ID [2] 0 0
CA233-0000
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986484
Treatment: Other - Nivolumab

Experimental: Part 1A: BMS-986484 Dose Escalation -

Experimental: Part 1B: BMS-986484 + Nivolumab Dose Escalation -

Experimental: Part 2A: BMS-986484 Dose Expansion -

Experimental: Part 2B: BMS-986484 + Nivolumab Dose Expansion -


Treatment: Drugs: BMS-986484
Specified dose on specified days

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

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
Up to approximately 2 years
Primary outcome [2] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [2] 0 0
Up to approximately 2 years
Primary outcome [3] 0 0
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Timepoint [3] 0 0
Up to approximately 28 days
Primary outcome [4] 0 0
Incidence of AEs leading to discontinuation
Timepoint [4] 0 0
Up to approximately 2 years
Primary outcome [5] 0 0
Incidence of AEs leading to death
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Maximum observed concentration (Cmax)
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Time of maximum observed concentration (Tmax)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Area under the concentration-time curve (AUC)
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Incidence of anti-drug antibodies (ADAs)
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Timepoint [7] 0 0
Up to approximately 2 years

Eligibility
Key inclusion criteria
* Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN).
* Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1).
* Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of or with active interstitial lung disease or pulmonary fibrosis.
* Active, known, or suspected autoimmune disease.
* Serious uncontrolled medical disorders.
* New onset, non-catheter-associated venous thromboembolism within the past 6 months.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
29/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/10/2027
Actual
Sample size
Target
134
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Local Institution - 0021 - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - 0019 - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
5112 - Elizabeth Vale
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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
South Dakota
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec

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
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: 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/NCT06544655