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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)
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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
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Secondary ID [1]
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2025-522598-12
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Secondary ID [2]
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CA240-0030
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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:
Pancreatic Ductal Adenocarcinoma
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Condition category
Condition code
Cancer
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Pancreatic
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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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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Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1)
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Assessment method [1]
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Defined as the time between the randomization date and the date of progressive disease (PD) or death from any cause (whichever occurs first)
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Timepoint [1]
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Up to 3 years after last participant is randomized
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Defined as the time from the randomization date to the date of death from any cause
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Timepoint [2]
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Up to 3 years after last participant is randomized
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Secondary outcome [1]
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Objective Response (OR) as assessed by RECIST v1.1
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Assessment method [1]
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Timepoint [1]
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Up to 3 years after last participant is randomized
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Secondary outcome [2]
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Duration of Response (DOR) as assessed by RECIST v1.1
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Assessment method [2]
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Defined as the time between the date of the first documentation of objective tumor response (complete response (CR) or partial response (PR)) and the date of disease progression or to death from any cause (whichever occurs first)
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Timepoint [2]
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Up to 3 years after last participant is randomized
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Secondary outcome [3]
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Time to Objective Response (TTOR) as assessed by RECIST v1.1
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Assessment method [3]
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Defined as the time between randomization to the date of the first documentation of objective tumor response
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Timepoint [3]
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Up to 3 years after last participant is randomized
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Secondary outcome [4]
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Disease control as assessed by RECIST v1.1
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Assessment method [4]
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Defined as the best overall response (BOR) of confirmed CR, PR, or stable disease (SD)
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Timepoint [4]
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Up to 3 years after last participant is randomized
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Secondary outcome [5]
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PFS as assessed by RECIST v1.1
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Assessment method [5]
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Timepoint [5]
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Up to 3 years after last participant is randomized
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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.
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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
* 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.
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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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Masking / blinding
Blinded (masking used)
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The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Recruitment
Recruitment status
Recruiting
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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
3/11/2025
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Actual
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Actual
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Date of last data collection
Anticipated
3/05/2029
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Actual
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Sample size
Target
470
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0227 - St Leonards
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Local Institution - 0228 - Brisbane
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Local Institution - 0226 - Brisbane
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Local Institution - 0229 - Woodville
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Local Institution - 0232 - Malvern
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Local Institution - 0231 - Melbourne
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Local Institution - 0230 - Murdoch
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2065 - St Leonards
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4029 - Brisbane
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4102 - Brisbane
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5011 - Woodville
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3144 - Malvern
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3076 - Melbourne
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Recruitment postcode(s) [7]
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6150 - Murdoch
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0
Petah Tikva
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0
0
Italy
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0
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Campania
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Italy
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0
Emilia-Romagna
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Italy
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Lazio
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Country [128]
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Italy
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Lombardy
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Italy
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State/province [129]
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Milano
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Italy
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State/province [130]
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Tuscany
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Italy
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State/province [131]
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Veneto
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Country [132]
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Italy
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State/province [132]
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Milan
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Italy
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State/province [133]
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Verona
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Japan
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State/province [134]
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Aichi-ken
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Japan
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Chiba
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Japan
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Hokkaido
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Japan
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Kanagawa
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Japan
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Tokyo
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Japan
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Osaka
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Malaysia
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State/province [140]
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Kuala Lumpur
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Malaysia
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Sarawak
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Mexico
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Jalisco
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Mexico
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Mexico City
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Mexico
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Nuevo León
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Mexico
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Oaxaca
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Mexico
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Querétaro
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Mexico
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Puebla City
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Netherlands
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Limburg
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Netherlands
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North Brabant
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Netherlands
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South Holland
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Poland
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Greater Poland Voivodeship
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Poland
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Masovian Voivodeship
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Poland
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Pomeranian Voivodeship
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Poland
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State/province [154]
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Gdansk
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Romania
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Cluj
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Romania
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Dolj
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Romania
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Prahova
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Romania
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Bucharest
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Romania
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Cluj-Napoca
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Romania
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Ia?i
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Singapore
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Central Singapore
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Singapore
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Singapore
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Slovakia
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Banská Bystrica Region
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Slovakia
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Košice Region
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Slovakia
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State/province [165]
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Trencín Region
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Slovakia
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Bratislava
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South Africa
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Gauteng
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Country [168]
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South Africa
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State/province [168]
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Western Cape
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South Korea
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State/province [169]
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Seoul-teukbyeolsi [Seoul]
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Spain
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Barcelona [Barcelona]
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Spain
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Catalunya [Cataluña]
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Spain
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Madrid, Comunidad de
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Spain
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Madrid
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Spain
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Seville
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Spain
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Zaragoza
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Sweden
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State/province [176]
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Skåne Län [se-12]
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Sweden
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State/province [177]
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Stockholms Län [se-01]
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Country [178]
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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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Switzerland
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Canton Ticino
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Switzerland
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Geneva
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan District
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Turkey (Türkiye)
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Istanbul
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Turkey (Türkiye)
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Adana
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Turkey (Türkiye)
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Ankara
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United Kingdom
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England
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United Kingdom
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Kensington and Chelsea
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United Kingdom
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London, City of
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Country [193]
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United Kingdom
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State/province [193]
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Metropolitan Borough of Wirral
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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 assess the safety and efficacy of BMS-986504, a selective, MTA-cooperative PRMT5 inhibitor, in combination with Nab-paclitaxel/Gemcitabine (nab-p/gem) versus placebo in combination with nab-p/gem, in participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with homozygous methylthioadenosine phosphorylase (MTAP) deletion.
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Trial website
https://clinicaltrials.gov/study/NCT07076121
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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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0
Bristol-Myers Squibb
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Country
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0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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Address
0
0
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Country
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0
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Phone
0
0
855-907-3286
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Fax
0
0
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Email
0
0
[email protected]
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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/disclosure-commitment.html
Query!
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/NCT07076121
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