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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07076121




Registration number
NCT07076121
Ethics application status
Date submitted
14/07/2025
Date registered
21/07/2025
Date last updated
11/09/2025

Titles & IDs
Public title
A Study Comparing BMS-986504 in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma With Homozygous MTAP Deletion (MountainTAP-30)
Scientific title
A Randomized, Phase 2/3 Study Comparing BMS-986504 in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma Harboring Homozygous MTAP Deletion
Secondary ID [1] 0 0
2025-522598-12
Secondary ID [2] 0 0
CA240-0030
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Ductal Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986504
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Placebo

Experimental: Arm A -

Experimental: Arm B -

Placebo comparator: Arm C -

Placebo comparator: Arm D -

Experimental: Arm E -

Placebo comparator: Arm F -


Treatment: Drugs: BMS-986504
Specified dose on specified days

Treatment: Drugs: Gemcitabine
Specified dose on specified days

Treatment: Drugs: Nab-paclitaxel
Specified dose on specified days

Treatment: Drugs: Placebo
Specified dose on specified days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1)
Timepoint [1] 0 0
Up to 3 years after last participant is randomized
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to 3 years after last participant is randomized
Secondary outcome [1] 0 0
Objective Response (OR) as assessed by RECIST v1.1
Timepoint [1] 0 0
Up to 3 years after last participant is randomized
Secondary outcome [2] 0 0
Duration of Response (DOR) as assessed by RECIST v1.1
Timepoint [2] 0 0
Up to 3 years after last participant is randomized
Secondary outcome [3] 0 0
Time to Objective Response (TTOR) as assessed by RECIST v1.1
Timepoint [3] 0 0
Up to 3 years after last participant is randomized
Secondary outcome [4] 0 0
Disease control as assessed by RECIST v1.1
Timepoint [4] 0 0
Up to 3 years after last participant is randomized
Secondary outcome [5] 0 0
PFS as assessed by RECIST v1.1
Timepoint [5] 0 0
Up to 3 years after last participant is randomized

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC).
* Evidence of homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss detected in tumor tissue.
* Metastatic disease with at least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1).
* Participants must not have received any systemic anticancer treatments in the metastatic setting.
* If clinically indicated and as per investigator discretion, participants may receive up to 1 cycle of Nab-paclitaxel/Gemcitabine (nab-p/gem) in the metastatic setting and must have not progressed or required discontinuation due to intolerable toxicity.
* Initial cycle of nab-p/gem administered in the metastatic setting must have been completed prior to randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening.
* 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0227 - St Leonards
Recruitment hospital [2] 0 0
Local Institution - 0228 - Brisbane
Recruitment hospital [3] 0 0
Local Institution - 0226 - Brisbane
Recruitment hospital [4] 0 0
Local Institution - 0229 - Woodville
Recruitment hospital [5] 0 0
Local Institution - 0232 - Malvern
Recruitment hospital [6] 0 0
Local Institution - 0231 - Melbourne
Recruitment hospital [7] 0 0
Local Institution - 0230 - Murdoch
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4029 - Brisbane
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
3076 - Melbourne
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
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Limburg
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Zaragoza
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Sweden
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Stockholms Län [se-01]
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Sweden
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Uppsala Län [se-03]
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Sweden
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Västra Götalands Län [se-14]
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Switzerland
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Canton of Bern
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Switzerland
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Canton of St. Gallen
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Istanbul
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Adana
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London, City of
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United Kingdom
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Metropolitan Borough of Wirral

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
855-907-3286
Fax 0 0
Email 0 0
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 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)
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.