A Study of BMS-986504 in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion (MountainTAP-9)

NCT ID: NCT06855771

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-09

Study Completion Date

2031-12-30

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of BMS-986504 monotherapy in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion after progression on prior therapies.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: BMS-986504 Dose 1

Group Type EXPERIMENTAL

BMS-986504

Intervention Type DRUG

Specified dose on specified days

Arm B: BMS-986504 Dose 2

Group Type EXPERIMENTAL

BMS-986504

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986504

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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MRTX1719

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central MTAP status confirmation.
* Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition).
* At least 1 measurable lesion as per RECIST v1.1.
* Documented radiographic disease progression on or after the most recent line of treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.
* Capability to swallow tablets intact (without chewing or crushing).

Exclusion Criteria

* Active brain metastases or carcinomatous meningitis.
* History of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
* Prior treatment with a PRMT5 or MAT2A inhibitor.
* Known severe hypersensitivity to study treatment and/or any of its excipients.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Alaska Oncology and Hematology

Anchorage, Alaska, United States

Site Status RECRUITING

Local Institution - 0099

Boise, Idaho, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0090

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status RECRUITING

Local Institution - 0104

St Louis, Missouri, United States

Site Status NOT_YET_RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Local Institution - 0079

Shirley, New York, United States

Site Status NOT_YET_RECRUITING

Gabrail Cancer Center

Canton, Ohio, United States

Site Status RECRUITING

Providence Portland Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Local Institution - 0103

Portland, Oregon, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0078

Seattle, Washington, United States

Site Status NOT_YET_RECRUITING

Local Institution - 0084

Milwaukee, Wisconsin, United States

Site Status NOT_YET_RECRUITING

GenesisCare - Campbelltown

Campbelltown, New South Wales, Australia

Site Status RECRUITING

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Site Status RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status RECRUITING

GenesisCare - St Andrew's

Adelaide, South Australia, Australia

Site Status RECRUITING

Local Institution - 0039

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Local Institution - 0055

Xiamen, Fujian, China

Site Status NOT_YET_RECRUITING

Local Institution - 0050

Nanning, Guangxi, China

Site Status NOT_YET_RECRUITING

Local Institution - 0043

Nanchang, Jiangxi, China

Site Status NOT_YET_RECRUITING

Local Institution - 0056

Changchun, Jilin, China

Site Status NOT_YET_RECRUITING

Local Institution - 0054

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Local Institution - 0044

Linyi, Shandong, China

Site Status NOT_YET_RECRUITING

Local Institution - 0049

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Local Institution - 0053

Linhai, Zhejiang, China

Site Status NOT_YET_RECRUITING

Local Institution - 0045

Marseille, Bouches-du-Rhône, France

Site Status NOT_YET_RECRUITING

Chu Grenoble Alpes

La Tronche, Isère, France

Site Status RECRUITING

Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

Saint-Herblain, Loire-Atlantique, France

Site Status RECRUITING

Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

Site Status RECRUITING

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, Rhône, France

Site Status RECRUITING

Hopitaux Universitaires Paris Centre-Hopital Cochin

Paris, , France

Site Status RECRUITING

Local Institution - 0107

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital Tenon

Paris, , France

Site Status RECRUITING

Groupe hospitalier Paris saint Joseph

Paris, Île-de-France Region, France

Site Status RECRUITING

Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, Bavaria, Germany

Site Status RECRUITING

Universitätsklinikum Frankfurt Goethe-Universität

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Krankenhaus Martha-Maria Halle-Dölau

Halle, Saxony-Anhalt, Germany

Site Status RECRUITING

Universitaetsklinikum Koeln

Cologne, , Germany

Site Status RECRUITING

Universitaetsklinikum Wuerzburg

Würzburg, , Germany

Site Status RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Napoli, Campania, Italy

Site Status RECRUITING

Local Institution - 0026

Napoli, Campania, Italy

Site Status NOT_YET_RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, Italy

Site Status RECRUITING

Local Institution - 0022

Milan, Milano, Italy

Site Status NOT_YET_RECRUITING

Local Institution - 0024

Bologna, , Italy

Site Status NOT_YET_RECRUITING

Local Institution - 0019

Milan, , Italy

Site Status NOT_YET_RECRUITING

Local Institution - 0023

Padua, , Italy

Site Status NOT_YET_RECRUITING

Local Institution - 0092

Kashiwa, Chiba, Japan

Site Status NOT_YET_RECRUITING

Local Institution - 0094

Sendai, Miyagi, Japan

Site Status NOT_YET_RECRUITING

Local Institution - 0093

Hirakata, Osaka, Japan

Site Status NOT_YET_RECRUITING

Mazowiecki Szpital Onkologiczny

Wieliszew, Masovian Voivodeship, Poland

Site Status RECRUITING

Local Institution - 0064

Prabuty, , Poland

Site Status NOT_YET_RECRUITING

Local Institution - 0029

Bucharest, București, Romania

Site Status NOT_YET_RECRUITING

Local Institution - 0036

Florești, Cluj, Romania

Site Status NOT_YET_RECRUITING

Local Institution - 0031

Craiova, Dolj, Romania

Site Status NOT_YET_RECRUITING

Local Institution - 0040

Bucharest, , Romania

Site Status NOT_YET_RECRUITING

Local Institution - 0034

Cluj-Napoca, , Romania

Site Status NOT_YET_RECRUITING

Local Institution - 0030

Iași, , Romania

Site Status NOT_YET_RECRUITING

Local Institution - 0032

Iași, , Romania

Site Status NOT_YET_RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Site Status RECRUITING

Local Institution - 0073

Hospitalet, Barcelona [Barcelona], Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

H.R.U Málaga - Hospital General

Málaga, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status RECRUITING

Karolinska Universitetssjukhuset Solna

Solna, Stockholms Län [se-01], Sweden

Site Status RECRUITING

Sahlgrenska Universitetssjukhuset

Gothenburg, Västra Götalands Län [se-14], Sweden

Site Status RECRUITING

Local Institution - 0069

Birmingham, England, United Kingdom

Site Status NOT_YET_RECRUITING

Sarah Cannon Research Institute UK

London, London, City of, United Kingdom

Site Status RECRUITING

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia China France Germany Italy Japan Poland Romania Spain Sweden United Kingdom

Central Contacts

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BMS Study Connect Contact Center www.BMSStudyConnect.com

Role: CONTACT

Phone: 855-907-3286

Email: [email protected]

First line of the email MUST contain NCT # and Site #.

Role: CONTACT

Facility Contacts

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Steven Liu, Site 0088

Role: primary

Site 0099

Role: primary

Site 0090

Role: primary

Dipesh Uprety, Site 0100

Role: primary

Site 0104

Role: primary

Kathryn Arbour, Site 0018

Role: primary

Site 0079

Role: primary

Nashat Gabrail, Site 0091

Role: primary

Rachel Sanborn, Site 0098

Role: primary

Site 0103

Role: primary

Site 0078

Role: primary

Site 0084

Role: primary

Jessica Smith, Site 0057

Role: primary

Steven Kao, Site 0059

Role: primary

Wen Xu, Site 0058

Role: primary

VY Broadbridge, Site 0097

Role: primary

Site 0039

Role: primary

Site 0055

Role: primary

Site 0050

Role: primary

Site 0043

Role: primary

Site 0056

Role: primary

Site 0054

Role: primary

Site 0044

Role: primary

Site 0049

Role: primary

Site 0053

Role: primary

Site 0045

Role: primary

Denis Moro-Sibilot, Site 0015

Role: primary

Elvire Pons-Tostivint, Site 0012

Role: primary

Bertrand Mennecier, Site 0095

Role: primary

Michael Duruisseaux, Site 0041

Role: primary

Marie Wislez, Site 0013

Role: primary

Site 0107

Role: primary

Jacques Cadranel, Site 0027

Role: primary

Carole Helissey-Danis, Site 0096

Role: primary

Diego Kauffmann-Guerrero, Site 0068

Role: primary

Fabian Acker, Site 0070

Role: primary

Miriam Moeller, Site 0066

Role: primary

Juergen Wolf, Site 0067

Role: primary

Elisabeth Goebeler, Site 0065

Role: primary

Alessandro Morabito, Site 0020

Role: primary

Site 0026

Role: primary

Diego Cortinovis, Site 0025

Role: primary

Site 0022

Role: primary

Site 0024

Role: primary

Site 0019

Role: primary

Site 0023

Role: primary

Site 0092

Role: primary

Site 0094

Role: primary

Site 0093

Role: primary

Renata Biernacka, Site 0060

Role: primary

Site 0064

Role: primary

Site 0029

Role: primary

Site 0036

Role: primary

Site 0031

Role: primary

Site 0040

Role: primary

Site 0034

Role: primary

Site 0030

Role: primary

Site 0032

Role: primary

Enriqueta Felip Font, Site 0074

Role: primary

Site 0073

Role: primary

Maria Eugenia Olmedo Garcia, Site 0077

Role: primary

Luis Paz-Ares Rodriguez, Site 0071

Role: primary

Javier de Castro Carpeno, Site 0076

Role: primary

Manuel Cobo-Dols, Site 0075

Role: primary

Reyes Bernabe Caro, Site 0089

Role: primary

Oscar Juan Vidal, Site 0072

Role: primary

Luigi DePetris, Site 0002

Role: primary

Andreas Hallqvist, Site 0003

Role: primary

Site 0069

Role: primary

Elisa Fontana, Site 0008

Role: primary

Alastair Greystoke, Site 0004

Role: primary

Related Links

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Other Identifiers

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2024-519814-29

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1315-9473

Identifier Type: OTHER

Identifier Source: secondary_id

CA240-0009

Identifier Type: -

Identifier Source: org_study_id