A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM

NCT03723655 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: CV027-003
• Study Type: interventional
• Target: 314
• Locations: 13 countries
• Sites: 68

Brief Summary

Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study. Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study. Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.

Conditions

Hypertrophic Cardiomyopathy; Obstructive Hypertrophic Cardiomyopathy; Non-obstructive Hypertrophic Cardiomyopathy

Keywords

Symptomatic, left ventricular outflow tract gradient

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of treatment-emergent adverse events and serious adverse events

  252 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

Active Treatment for participants with base target trough concentration

Drug: mavacamten

Group 2

EXPERIMENTAL

Active Treatment for participants with higher target trough concentration

Drug: mavacamten

Group 3

EXPERIMENTAL

Active Treatment for participants dose titrated to clinical response

Drug: mavacamten

Interventions

mavacamten DRUG

mavacamten capsules

Also known as: MYK-461

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a body weight greater than 45 kg at the Screening Visit
• Has adequate acoustic windows to enable accurate TTEs.
• Has documented LVEF ≥ 50% by echocardiography core laboratory read of screening TTE at rest.
• Has safety laboratory parameters (chemistry, hematology, coagulation, and urinalysis) within normal limits (according to the central laboratory reference range).
• Female participants must not be pregnant or lactating and, if sexually active, must use one of the following highly effective birth control methods from the Screening Visit through 90 days after the last dose of investigational medicinal product (IMP).
• In addition to the above contraceptive requirements for female participants, male partners must also use a contraceptive (eg. barrier, condom, or vasectomy).

You may not qualify if:

• Has any ECG abnormality considered by the investigator to pose a risk to participant safety (eg. second degree atrioventricular block type II).
• Has a history of syncope or a history of sustained ventricular tachyarrhythmia with exercise between Parent Study EOS Visit and Screening Visit.
• Has a history of resuscitated sudden cardiac arrest or known history of appropriate implantable cardioverter-defibrillator (ICD) discharge for life-threatening ventricular arrhythmia between Parent Study EOS Visit and Screening Visit. (Note: history of anti-tachycardia pacing (ATP) is allowed).• Currently treated with disopyramide or ranolazine (within 14 days prior to Screening) or treatment with disopyramide or ranolazine is planned during the study.
• Has any acute or serious comorbid condition (eg. major infection or hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction) that, in the judgment of the Investigator, could lead to premature termination of study participation or interfere with the measurement or interpretation of the efficacy and safety assessments in the study.
• History of clinically significant malignant disease that developed since enrollment in the Parent Study.
• Is unable to comply with the study requirements, including the number of required visits to the clinical site.
• Has participated in a clinical trial in which the participant received any investigational drug (or is currently using an investigational device) within 30 days prior to Screening, or at least 5 times the respective elimination half-life (whichever is longer), except for participation in MAVERICK-HCM or EXPLORER-HCM. Prior participation in a non-interventional observational study is allowed.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (68)

Local Institution - 0045

Scottsdale, Arizona, 85259, United States

Location

Local Institution - 0058

Los Angeles, California, 90027, United States

Location

Local Institution - 0066

San Francisco, California, 94143, United States

Location

Local Institution - 0063

Stanford, California, 94305, United States

Location

Local Institution - 0043

New Haven, Connecticut, 06520-8017, United States

Location

Local Institution - 0067

Jacksonville, Florida, 32224, United States

Location

Local Institution - 0050

Chicago, Illinois, 60611, United States

Location

Local Institution - 0070

Indianapolis, Indiana, 46260, United States

Location

Local Institution - 0049

Iowa City, Iowa, 52242, United States

Location

Local Institution - 0054

Boston, Massachusetts, 02115, United States

Location

Local Institution - 0051

Ann Arbor, Michigan, 48109, United States

Location

Local Institution - 0074

Grand Rapids, Michigan, 49503, United States

Location

Local Institution - 0048

St Louis, Missouri, 63110, United States

Location

Local Institution - 0060

New York, New York, 10016, United States

Location

Local Institution - 0056

New York, New York, 10032, United States

Location

Local Institution - 0071

Charlotte, North Carolina, 28204, United States

Location

Local Institution - 0047

Durham, North Carolina, 27710, United States

Location

Local Institution - 0052

Cincinnati, Ohio, 45267, United States

Location

Local Institution - 0044

Portland, Oregon, 97239, United States

Location

Local Institution - 0068

Bethlehem, Pennsylvania, 18015, United States

Location

Local Institution - 0046

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution - 0064

Pittsburgh, Pennsylvania, 15213, United States

Location

Local Institution - 0073

Memphis, Tennessee, 38104, United States

Location

Local Institution - 0061

Dallas, Texas, 75390, United States

Location

Local Institution - 0055

Houston, Texas, 77030, United States

Location

Local Institution - 0057

Houston, Texas, 77030, United States

Location

Local Institution - 0072

Murray, Utah, 84107-5701, United States

Location

Local Institution - 0062

Salt Lake City, Utah, 84112, United States

Location

Local Institution - 0053

Charlottesville, Virginia, 22903, United States

Location

Local Institution - 0059

Richmond, Virginia, 23298, United States

Location

Local Institution - 0065

Seattle, Washington, 98195, United States

Location

Local Institution - 0002

Aalst, 9300, Belgium

Location

Local Institution - 0001

Brussels, 1070, Belgium

Location

Local Institution - 0003

Edegem, 2650, Belgium

Location

Local Institution - 0010

Prague, 128 08, Czechia

Location

Local Institution - 0009

Prague, 140 21, Czechia

Location

Local Institution - 0011

Aarhus, 8000, Denmark

Location

Local Institution - 0012

Frederiksberg, 2000, Denmark

Location

Local Institution - 0013

Odense, 5000, Denmark

Location

Local Institution - 0014

Nantes, 44093, France

Location

Local Institution - 0017

Paris, 75013, France

Location

Local Institution - 0016

Paris, 75015, France

Location

Local Institution - 0015

Toulouse, 31059, France

Location

Local Institution - 0020

Bad Nauheim, 61231, Germany

Location

Local Institution - 0018

Dresden, 01277, Germany

Location

Local Institution - 0019

Göttingen, 37075, Germany

Location

Local Institution - 0021

Heidelberg, 69120, Germany

Location

Local Institution - 0027

Jerusalem, 9112001, Israel

Location

Local Institution - 0024

Petah Tikva, 4941492, Israel

Location

Local Institution - 0022

Ramat Gan, 52621, Israel

Location

Local Institution - 0025

Rehovot, 76100, Israel

Location

Local Institution - 0023

Safed, 13100, Israel

Location

Local Institution - 0026

Tel Aviv, 6423906, Israel

Location

Local Institution - 0028

Florence, 50139, Italy

Location

Local Institution - 0029

Maastricht, 6229 HX, Netherlands

Location

Local Institution - 0030

Rotterdam, 3015 CE, Netherlands

Location

Local Institution - 0033

Katowice, 40-555, Poland

Location

Local Institution - 0034

Krakow, 31-501, Poland

Location

Local Institution - 0031

Poznan, 61-848, Poland

Location

Local Institution - 0032

Warsaw, 04-628, Poland

Location

Local Institution - 0036

Almada, 2805-267, Portugal

Location

Local Institution - 0035

Lisbon, 1500-650, Portugal

Location

Local Institution - 0038

A Coruña, 15006, Spain

Location

Local Institution - 0037

El Palmar, 30120, Spain

Location

Local Institution - 0040

Madrid, 28034, Spain

Location

Local Institution - 0039

Majadahonda, 28222, Spain

Location

Local Institution - 0041

Seville, 41009, Spain

Location

Local Institution - 0042

London, W1G 8PH, United Kingdom

Location

Related Publications (1)

• Rader F, Oreziak A, Choudhury L, Saberi S, Fermin D, Wheeler MT, Abraham TP, Garcia-Pavia P, Zwas DR, Masri A, Owens A, Hegde SM, Seidler T, Fox S, Balaratnam G, Sehnert AJ, Olivotto I. Mavacamten Treatment for Symptomatic Obstructive Hypertrophic Cardiomyopathy: Interim Results From the MAVA-LTE Study, EXPLORER-LTE Cohort. JACC Heart Fail. 2024 Jan;12(1):164-177. doi: 10.1016/j.jchf.2023.09.028.

  PMID: 38176782 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Interventions

MYK-461

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Site, Care Provider and Patients are blinded to study dose. Sponsor is now unblinded to study dose.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 29, 2018
• Study Start: September 27, 2018
• Primary Completion: January 16, 2026
• Study Completion: January 16, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

DE (4); NL (2); FR (4); CZ (2); ES (5); IT (1); IL (6); BE (3); US (31); GB (1); DK (3); PL (4); PT (2)