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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06618287




Registration number
NCT06618287
Ethics application status
Date submitted
26/09/2024
Date registered
1/10/2024

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
Scientific title
A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors
Secondary ID [1] 0 0
2024-514947-27
Secondary ID [2] 0 0
CA244-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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: Drugs - BMS-986507
Treatment: Drugs - Osimertinib
Treatment: Drugs - Pembrolizumab

Experimental: Group A -

Experimental: Group B -


Treatment: Drugs: BMS-986507
Specified dose on specified days

Treatment: Drugs: Osimertinib
Specified dose on specified days

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

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs)
Timepoint [1] 0 0
Up to 3 years
Primary outcome [2] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [2] 0 0
Up to 3 years
Primary outcome [3] 0 0
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera
Timepoint [3] 0 0
Up to 3 years
Primary outcome [4] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [4] 0 0
Up to 3 years
Primary outcome [5] 0 0
Number of participants with AEs leading to death
Timepoint [5] 0 0
Up to 3 years
Primary outcome [6] 0 0
Number of DLTs that occur during the DLT evaluation period
Timepoint [6] 0 0
Up to 3 weeks
Secondary outcome [1] 0 0
Maximum observed serum concentration (Cmax)
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Time of maximum observed concentration (Tmax)
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Area under the serum concentration-time curve within a dosing interval (AUC(TAU))
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
Objective response rate (ORR)
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Duration of response (DOR)
Timepoint [6] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
Inclusion Criteria

* Participants must have at least one measurable lesion per response evaluation criteria in solid tumors.
* Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Participants must have a life expectancy of at least 3 months at the time of the first dose.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology.
* Participants must not have any untreated symptomatic central nervous system (CNS) metastases.
* Participants must not have a history of serious recurrent infections.
* Participants must not have a history of severe heart 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
Single group
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
25/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/12/2027
Actual
Sample size
Target
218
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Local Institution - 0027 - Liverpool
Recruitment hospital [2] 0 0
Local Institution - 0028 - Woolloongabba
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
Canada
State/province [6] 0 0
Alberta
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Netherlands
State/province [9] 0 0
Zuid-Holland
Country [10] 0 0
Netherlands
State/province [10] 0 0
Amsterdam
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona [Barcelona]
Country [12] 0 0
Spain
State/province [12] 0 0
Madrid, Comunidad De
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid
Country [14] 0 0
United Kingdom
State/province [14] 0 0
England
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Glasgow City
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Newcastle upon Tyne

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 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)?
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 Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.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/disclosure-commitment.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/NCT06618287