A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)

September 15, 2026 updated by: Bristol-Myers Squibb

A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion

This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Part 1 will include parallel enrolment of tumor-specific dose-expansion cohorts evaluating BMS-986504 as monotherapy. Part 2 will include dose-escalation cohorts in which BMS-986504 is given in combination with other anticancer agents. Additional cohorts may be added based on emerging data.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Belgium
    • Bruxelles-Capitale, Région de
      • Brussels, Bruxelles-Capitale, Région de, Belgium, 1090
        • Recruiting
        • UZ Brussel
        • Contact:
          • Bart Neyns, Site 0077
          • Phone Number: 3224775457
      • Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
        • Not yet recruiting
        • Local Institution - 0148
        • Contact:
          • Site 0148
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Not yet recruiting
        • Local Institution - 0114
        • Contact:
          • Site 0114
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V2S 0C2
        • Not yet recruiting
        • Local Institution - 0051
        • Contact:
          • Site 0051
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Not yet recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
      • Toronto, Ontario, Canada, M5G 2M9
        • Not yet recruiting
        • Local Institution - 0007
        • Contact:
          • Site 0007
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100071
        • Not yet recruiting
        • Local Institution - 0155
        • Contact:
          • Site 0155
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Not yet recruiting
        • Local Institution - 0185
        • Contact:
          • Site 0185
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Local Institution - 0184
        • Contact:
          • Site 0184
    • Henan
      • Xinxiang, Henan, China, 453100
        • Recruiting
        • The First Affiliated Hospital of Henan Medical University
        • Contact:
          • Ying-Hua Ji, Site 0152
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201321
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Jian Zhang, Site 0153
          • Phone Number: 18017312991
      • Shanghai, Shanghai Municipality, China, 200131
        • Recruiting
        • Shanghai GoBroad Cancer Hospital China Pharmaceutical University
        • Contact:
          • Jun Zhou, Site 0156
          • Phone Number: +8613901906998
  • France
      • Paris, France, 75010
        • Not yet recruiting
        • Local Institution - 0074
        • Contact:
          • Site 0074
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21079
        • Not yet recruiting
        • Local Institution - 0078
        • Contact:
          • Site 0078
    • Rhône
      • Pierre-Bénite, Rhône, France, 69310
        • Not yet recruiting
        • Local Institution - 0075
        • Contact:
          • Site 0075
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94800
        • Not yet recruiting
        • Local Institution - 0116
        • Contact:
          • Site 0116
  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaetsklinikum Hamburg
        • Contact:
          • Joseph Tintelnot, Site 0040
          • Phone Number: +4915222818699
      • Heidelberg, Germany, 69120
        • Not yet recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
      • Leipzig, Germany, 04103
        • Not yet recruiting
        • Local Institution - 0061
        • Contact:
          • Site 0061
      • München, Germany, 81675
        • Not yet recruiting
        • Local Institution - 0049
        • Contact:
          • Site 0049
      • Würzburg, Germany, 97080
        • Not yet recruiting
        • Local Institution - 0047
        • Contact:
          • Site 0047
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Not yet recruiting
        • Local Institution - 0081
        • Contact:
          • Site 0081
  • Hong Kong
      • Hksar, Hong Kong, 999077
        • Not yet recruiting
        • Local Institution - 0150
        • Contact:
          • Site 0150
      • Shatin, Hong Kong, NT
        • Not yet recruiting
        • Local Institution - 0063
        • Contact:
          • Site 0063
  • Ireland
      • Cork, Ireland, T12 E8YV
        • Recruiting
        • Cork University Hospital
        • Contact:
          • Jack Gleeson, Site 0080
          • Phone Number: 0863313074
      • Dublin, Ireland, D08 E9P6
        • Not yet recruiting
        • Local Institution - 0146
        • Contact:
          • Site 0146
      • Dublin, Ireland, 7
        • Recruiting
        • Mater Misericordiae University Hospital (MMUH)
        • Contact:
          • Austin Duffy, Site 0023
          • Phone Number: 353018035481
  • Italy
      • Bergamo, Italy, 24127
        • Not yet recruiting
        • Local Institution - 0123
        • Contact:
          • Site 0123
      • Milan, Italy, 20133
        • Not yet recruiting
        • Local Institution - 0034
        • Contact:
          • Site 0034
      • Naples, Italy, 80131
        • Not yet recruiting
        • Local Institution - 0050
        • Contact:
          • Site 0050
      • Perugia, Italy, 06156
        • Not yet recruiting
        • Local Institution - 0082
        • Contact:
          • Site 0082
    • Tuscany
      • Siena, Tuscany, Italy, 53100
        • Not yet recruiting
        • Local Institution - 0073
        • Contact:
          • Site 0073
  • Japan
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
          • Jun Sato, Site 0020
          • Phone Number: 81335422511
  • Norway
      • Oslo, Norway, 0450
        • Recruiting
        • Oslo Universitetssykehus HF, Ullevål
        • Contact:
          • Tormod Kyrre Guren, Site 0022
          • Phone Number: 4799024906
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Recruiting
        • Haukeland universitetssjukehus
        • Contact:
          • Kristine Aasebo, Site 0171
          • Phone Number: +4755975000
  • South Korea
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Do-Youn Oh, Site 0004
          • Phone Number: 82220720701
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
          • Hye Jin Choi, Site 0058
          • Phone Number: 82222288133
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Dae Ho Lee, Site 0052
          • Phone Number: 82230103214
  • Spain
      • Madrid, Spain, 28028
        • Not yet recruiting
        • Local Institution - 0033
        • Contact:
          • Site 0033
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
        • Contact:
          • FATIMA TOSCANO, Site 0069
          • Phone Number: 955013068
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Not yet recruiting
        • Local Institution - 0068
        • Contact:
          • Site 0068
      • Hospitalet, Barcelona [Barcelona], Spain, 08907
        • Not yet recruiting
        • Local Institution - 0071
        • Contact:
          • Site 0071
  • United States
    • California
      • San Francisco, California, United States, 94158
        • Not yet recruiting
        • Local Institution - 0096
        • Contact:
          • Site 0096
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Local Institution - 0182
        • Contact:
          • Site 0182
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University - Winship Cancer Institute
        • Contact:
          • Gideon T Dosunmu, Site 0178
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
          • Kristen Marrone, Site 0143
          • Phone Number: 410-502-5140
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Local Institution - 0124
        • Contact:
          • Site 0124
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0922
        • Not yet recruiting
        • Local Institution - 0119
        • Contact:
          • Site 0119
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Local Institution - 0129
        • Contact:
          • Site 0129
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Local Institution - 0174
        • Contact:
          • Site 0174
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Local Institution - 0181
        • Contact:
          • Site 0181
    • New York
      • Buffalo, New York, United States, 14263
        • Not yet recruiting
        • Local Institution - 0142
        • Contact:
          • Site 0142
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Mrinal Gounder, Site 0139
          • Phone Number: 646-227-2198
      • New York, New York, United States, 10016
        • Not yet recruiting
        • Local Institution - 0170
        • Contact:
          • Site 0170
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Not yet recruiting
        • Local Institution - 0100
        • Contact:
          • Site 0100
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Local Institution - 0085
        • Contact:
          • Site 0085
    • Washington
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • Local Institution - 0086
        • Contact:
          • Site 0086
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Not yet recruiting
        • Local Institution - 0134
        • Contact:
          • Site 0134

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.
  • Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.
  • Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.
  • Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

  • Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.
  • Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
  • Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.
  • Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.
  • Participants must not have active viral HBV or HCV hepatitis.
  • Other protocol defined inclusion/exclusion criteria applies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 2: Cohort 1
BMS-986504 + Pumitamig + Chemotherapy
Drug: Carboplatin
Specified dose on specified days
Drug: Paclitaxel
Specified dose on specified days
Drug: Pemetrexed
Specified dose on specified days
Drug: Nab-paclitaxel
Specified dose on specified days
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Drug: Pumitamig
Specified dose on specified days
Other Names:
  • BNT327
Experimental: Part 2: Cohort 3
BMS-986504 + Nivolumab + Relatlimab FDC
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Drug: Nivolumab + Relatlimab FDC
Specified dose on specified days
Experimental: Part 2: Cohort 4
BMS-986504 + Temozolomide + Radiotherapy
Drug: Temozolomide
Specified dose on specified days
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Experimental: Part 1a
BMS-986504
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Experimental: Part 1b
BMS-986504
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Experimental: Part 2: Cohort 2a
BMS-986504 + Daraxonrasib
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Drug: Daraxonrasib
Specified dose on specified days
Other Names:
  • RMC 6236
Experimental: Part 2: Cohort 2b
BMS-986504 + Daraxonrasib
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Drug: Daraxonrasib
Specified dose on specified days
Other Names:
  • RMC 6236
Experimental: Part 2: Cohort 2c
BMS-986504 + Daraxonrasib + Chemotherapy
Drug: Gemcitabine
Specified dose on specified days
Drug: Nab-paclitaxel
Specified dose on specified days
Drug: BMS-986504
Specified dose on specified days
Other Names:
  • MRTX1719
  • Navlimetostat
Drug: Daraxonrasib
Specified dose on specified days
Other Names:
  • RMC 6236

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Number of participants who achieve Objective Response (OR)
Time Frame: Up to approximately 2 years
OR is defined as confirmed complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, Response Assessment in Neuro-Oncology (RANO) v2 or Modified RECIST v1.1
Up to approximately 2 years
Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with adverse events (AE)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with Serious AEs (SAEs)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with treatment related AEs
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with treatment related SAEs
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with AEs leading to study treatment discontinuation
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with AEs leading to death
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants with laboratory abnormalities
Time Frame: Up to approximately 2 years
Up to approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 1 and 2: Time to objective response (TTOR)
Time Frame: Up to approximately 2 years
Defined as time from first dose to the date of the first documentation of objective tumor response (CR or PR) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1
Up to approximately 2 years
Part 1 and 2: Duration of response (DOR)
Time Frame: Up to approximately 2 years
Defined as the time between the date of the first documentation of objective tumor response (CR or PR) and the date of disease progression or to death from any cause (whichever occurs first) by RECIST v1.1. or RANO v2 or Modified RECIST v1.1
Up to approximately 2 years
Part 1 and 2: Number of participants who achieve disease control (DC)
Time Frame: Up to approximately 2 years
Best Overall Response (BOR) of confirmed CR, confirmed PR, or stable disease (SD) for at least 4 months after start of treatment) by RECIST v1.1 or RANO v2 or Modified RECIST v1.1
Up to approximately 2 years
Part 1: Number of participants with adverse events (AE)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1: Number of participants with Serious AEs (SAEs)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1: Number of participants with treatment related AEs
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1: Number of participants with treatment related SAEs
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1: Number of participants with AEs leading to study treatment discontinuation
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1: Number of participants with AEs leading to death
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1: Number of participants with laboratory abnormalities
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 2: Number of participants who achieve Objective Response (OR)
Time Frame: Up to approximately 2 years
Up to approximately 2 years
Part 1 and 2: Number of participants who achieved clinical benefit (CB)
Time Frame: Up to approximately 2 years
CB defined as BOR of confirmed CR, confirmed PR, or SD for at least 4 months after start of treatment by RECIST v1.1 or RANO v2
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA240-0005
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-524285-18 (Other Identifier: EU CTR)
  • U1111-1330-1428 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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