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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07063745
Registration number
NCT07063745
Ethics application status
Date submitted
3/07/2025
Date registered
14/07/2025
Date last updated
11/09/2025
Titles & IDs
Public title
A Study to Compare the Combination of BMS-986504 With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
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Scientific title
A Randomized Phase 2/3 Study of BMS-986504 in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
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Secondary ID [1]
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2025-521511-40
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Secondary ID [2]
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CA240-0029
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Universal Trial Number (UTN)
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Trial acronym
MountainTAP-29
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Non-small Cell Lung Cancer With MTAP Deletion
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986504
Treatment: Drugs - Pembrolizumab
Other interventions - Placebo
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab-paclitaxel
Active comparator: Arm A: BMS-986504 + Pembrolizumab + Chemotherapy -
Active comparator: Arm B: BMS-986504 + Pembrolizumab + Chemotherapy -
Placebo comparator: Arm C: Placebo + Pembrolizumab + Chemotherapy -
Placebo comparator: Arm D: Placebo + Pembrolizumab + Chemotherapy -
Active comparator: Arm E: BMS-986504 + Pembrolizumab + Chemotherapy -
Placebo comparator: Arm F: Placebo + Pembrolizumab + Chemotherapy -
Treatment: Drugs: BMS-986504
Specified dose on specified days
Treatment: Drugs: Pembrolizumab
Specified dose on specified days
Other interventions: Placebo
Specified dose on specified days
Treatment: Drugs: Cisplatin
Specified dose on specified days
Treatment: Drugs: Carboplatin
Specified dose on specified days
Treatment: Drugs: Pemetrexed
Specified dose on specified days
Treatment: Drugs: Paclitaxel
Specified dose on specified days
Treatment: Drugs: Nab-paclitaxel
Specified dose on specified days
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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 (PFS)
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Assessment method [1]
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Timepoint [1]
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Up to 2 years
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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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Phase 3
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Timepoint [2]
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Up to 5 years
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Secondary outcome [1]
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Objective response (OR) (confirmed complete response (CR) or partial response (PR))
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Assessment method [1]
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Phase 2
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Timepoint [1]
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Up to 2 years
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Secondary outcome [2]
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Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD))
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Assessment method [2]
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Phase 2
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Timepoint [2]
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Up to 2 years
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Secondary outcome [3]
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Time to objective response (TTOR) (CR or PR)
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Assessment method [3]
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Phase 2
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Timepoint [3]
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Up to 2 years
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Secondary outcome [4]
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Duration of response (DOR) (CR or PR)
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Assessment method [4]
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Phase 2
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Timepoint [4]
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Up to 2 years
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Secondary outcome [5]
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OR (confirmed CR or PR)
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Assessment method [5]
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Phase 3
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Timepoint [5]
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Up to 5 years
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Secondary outcome [6]
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Disease control (BOR of confirmed CR, confirmed PR, or SD)
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Assessment method [6]
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Phase 3
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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DOR (CR or PR)
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Assessment method [7]
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Phase 3
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Timepoint [7]
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Up to 5 years
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Secondary outcome [8]
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PFS
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Assessment method [8]
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Timepoint [8]
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Up to 5 years
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Eligibility
Key inclusion criteria
Inclusion Criteria
* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.
* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Participants must have at least 1 measurable lesion as per RECIST v1.1.
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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
Exclusion Criteria
* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.
* Participants must not have symptomatic brain metastases or spinal cord compression.
* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC). Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.
* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.
* 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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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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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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Type of endpoint/s
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Statistical methods / analysis
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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
6/10/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
12/08/2031
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Actual
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Sample size
Target
590
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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,TAS,VIC
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Recruitment hospital [1]
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Local Institution - 0432 - Liverpool
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Local Institution - 0382 - Birtinya
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Local Institution - 0381 - Elizabeth Vale
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Local Institution - 0431 - Hobart
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Local Institution - 0367 - Ballarat Central
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Local Institution - 0373 - Woolloongabba
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2170 - Liverpool
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4575 - Birtinya
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Recruitment postcode(s) [3]
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5112 - Elizabeth Vale
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7000 - Hobart
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Recruitment postcode(s) [5]
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3350 - Ballarat Central
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Recruitment postcode(s) [6]
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QLD 4102 - Woolloongabba
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Recruitment outside Australia
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Yamaguchi
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Fukuoka
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Arnhem
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Bydgoszcz
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Romania
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Bucure?ti
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Romania
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Cluj
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Dolj
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Ilfov
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Prahova
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Bucharest
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Cluj-Napoca
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Ia?i
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Madrid, Comunidad de
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Valencia
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Tainan
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Taipei
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Bangkok
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Izmir
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Adana
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Ankara
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Antalya
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Bursa
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Turkey (Türkiye)
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Edirne
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United Kingdom
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London, City of
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to compare the clinical benefit of the combination of BMS-986504 (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion
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Trial website
https://clinicaltrials.gov/study/NCT07063745
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for public queries
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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8559073286
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[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 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)
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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
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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/NCT07063745
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