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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06764771




Registration number
NCT06764771
Ethics application status
Date submitted
3/01/2025
Date registered
8/01/2025

Titles & IDs
Public title
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Scientific title
A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Secondary ID [1] 0 0
CA234-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986488
Treatment: Drugs - Adagrasib
Treatment: Drugs - Cetuximab
Treatment: Drugs - Nivolumab

Experimental: Part 1A: BMS-986488 Monotherapy -

Experimental: Part 1B: BMS-986488 + Adagrasib -

Experimental: Part 1C: BMS-986488 + Adagrasib + Cetuximab -

Experimental: Part 1D: BMS-986488 + Nivolumab -

Experimental: Part 2A: BMS-986488 Monotherapy -

Experimental: Part 2B: BMS-986488 + Adagrasib -

Experimental: Part 2C: BMS-986488 + Adagrasib + Cetuximab -

Experimental: Part 2D: BMS-986488 + Nivolumab -


Treatment: Drugs: BMS-986488
Specified dose on specified days

Treatment: Drugs: Adagrasib
Specified dose on specified days

Treatment: Drugs: Cetuximab
Specified dose on specified days

Treatment: Drugs: Nivolumab
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
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Primary outcome [2] 0 0
Number of participants with Serious AEs (SAEs)
Timepoint [2] 0 0
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Primary outcome [3] 0 0
Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria
Timepoint [3] 0 0
From first dose of study treatment until end of cycle 1 (1 Cycle = 28 Days)
Primary outcome [4] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [4] 0 0
Until the end of the Safety Follow-up period (up to approximately 100 days after last dose)
Primary outcome [5] 0 0
Number of deaths
Timepoint [5] 0 0
From time of informed consent up to 52 weeks after end of treatment visit
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [1] 0 0
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Secondary outcome [2] 0 0
Time of maximum observed concentration (Tmax)
Timepoint [2] 0 0
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Secondary outcome [3] 0 0
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Timepoint [3] 0 0
Until Cycle 4, Day 1 (1 Cycle = 28 Days)
Secondary outcome [4] 0 0
Objective response rate (ORR)
Timepoint [4] 0 0
From time of informed consent up to 52 weeks after end of treatment visit
Secondary outcome [5] 0 0
Disease control rate (DCR)
Timepoint [5] 0 0
From time of informed consent up to 52 weeks after end of treatment visit
Secondary outcome [6] 0 0
Duration of response (DOR)
Timepoint [6] 0 0
From time of informed consent up to 52 weeks after end of treatment visit

Eligibility
Key inclusion criteria
* Participant must be = 18 years of age.
* Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:.
* Part 1A: clear-cell renal cell carcinoma (ccRCC) or clear-cell ovarian cancer (ccOC).
* Parts 2A, 1D, 2D: ccRCC.

i) Part 1B: solid tumors with KRAS G12C mutation.

ii) Part 2B: NSCLC with KRAS G12C mutation.

iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation.

* Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1.
* Participants must have measurable disease per RECIST v1.1.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Untreated central nervous system (CNS) metastases.
* Leptomeningeal metastasis (carcinomatous meningitis).
* Impaired cardiac function or clinically significant cardiac disease.
* For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):.

i) History of pneumonitis or interstitial lung disease (ILD).

ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

- 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
28/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/10/2027
Actual
Sample size
Target
437
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Local Institution - 0031 - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 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 Clinical Trials Contact Center www.BMSClinicalTrials.com
Address 0 0
Country 0 0
Phone 0 0
8559073286
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/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/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/NCT06764771