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

Last updated: February 18, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

2/3

Condition

Heart Defect

Heart Disease

Congestive Heart Failure

Treatment

mavacamten

Clinical Study ID

NCT03723655
CV027-003
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Has completed the Parent Study through to the EOS Visit within 90 days of consent. (Participants who are beyond the 90-day window from EOS Visit may be included inthis study pending MyoKardia Medical Monitoring approval) Participants whoprematurely discontinued from the Parent Study or the MAVA-LTE study may beconsidered for inclusion.

  • 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 TTEat rest.

  • Has safety laboratory parameters (chemistry, hematology, coagulation, andurinalysis) within normal limits (according to the central laboratory referencerange).

  • Female participants must not be pregnant or lactating and, if sexually active, mustuse one of the following highly effective birth control methods from the ScreeningVisit 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).

Exclusion

Key Exclusion Criteria:

  • Has any ECG abnormality considered by the investigator to pose a risk to participantsafety (eg. second degree atrioventricular block type II).

  • Has a history of syncope or a history of sustained ventricular tachyarrhythmia withexercise between Parent Study EOS Visit and Screening Visit.

  • Has a history of resuscitated sudden cardiac arrest or known history of appropriateimplantable cardioverter-defibrillator (ICD) discharge for life-threateningventricular arrhythmia between Parent Study EOS Visit and Screening Visit. (Note:history of anti-tachycardia pacing (ATP) is allowed).• Currently treated withdisopyramide or ranolazine (within 14 days prior to Screening) or treatment withdisopyramide 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 judgmentof the Investigator, could lead to premature termination of study participation orinterfere with the measurement or interpretation of the efficacy and safetyassessments in the study.

  • History of clinically significant malignant disease that developed since enrollmentin the Parent Study.

  • Is unable to comply with the study requirements, including the number of requiredvisits to the clinical site.

  • Has participated in a clinical trial in which the participant received anyinvestigational drug (or is currently using an investigational device) within 30days 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.

Study Design

Total Participants: 314
Treatment Group(s): 1
Primary Treatment: mavacamten
Phase: 2/3
Study Start date:
September 27, 2018
Estimated Completion Date:
January 16, 2026

Connect with a study center

  • Local Institution - 0002

    Aalst, 9300
    Belgium

    Site Not Available

  • Local Institution - 0002

    Aalst 2803448, 9300
    Belgium

    Site Not Available

  • Local Institution - 0001

    Brussels, 1070
    Belgium

    Site Not Available

  • Local Institution - 0001

    Brussels 2800866, 1070
    Belgium

    Site Not Available

  • Hôpital Erasme

    Bruxelles, 1070
    Belgium

    Site Not Available

  • Local Institution - 0003

    Edegem, 2650
    Belgium

    Site Not Available

  • Local Institution - 0003

    Edegem 2799007, 2650
    Belgium

    Site Not Available

  • Local Institution - 0009

    Prague, 140 21
    Czechia

    Site Not Available

  • Local Institution - 0009

    Prague 3067696, 140 21
    Czechia

    Site Not Available

  • Local Institution - 0010

    Prague 3067696, 128 08
    Czechia

    Site Not Available

  • Local Institution - 0010

    Praha 2, 128 08
    Czechia

    Site Not Available

  • Institut klinicke a experimentalni mediciny

    Praha 4, 140 21
    Czechia

    Site Not Available

  • Local Institution - 0011

    Aarhus, 8000
    Denmark

    Site Not Available

  • Local Institution - 0011

    Aarhus 2624652, 8000
    Denmark

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Local Institution - 0012

    Frederiksberg, 2000
    Denmark

    Site Not Available

  • Local Institution - 0012

    Frederiksberg 2621942, 2000
    Denmark

    Site Not Available

  • Local Institution - 0013

    Odense, 5000
    Denmark

    Site Not Available

  • Local Institution - 0013

    Odense 2615876, 5000
    Denmark

    Site Not Available

  • Local Institution - 0014

    Nantes, 44093
    France

    Site Not Available

  • Local Institution - 0014

    Nantes 2990969, 44093
    France

    Site Not Available

  • CHRU Nantes

    Nantes Cedex 1, 44093
    France

    Site Not Available

  • Local Institution - 0016

    Paris, 75015
    France

    Site Not Available

  • Local Institution - 0017

    Paris, 75013
    France

    Site Not Available

  • Local Institution - 0016

    Paris 2988507, 75015
    France

    Site Not Available

  • Local Institution - 0017

    Paris 2988507, 75013
    France

    Site Not Available

  • Local Institution - 0015

    Toulouse, 31059
    France

    Site Not Available

  • Local Institution - 0015

    Toulouse 2972315, 31059
    France

    Site Not Available

  • University Medicine Göttingen Germany

    Göttingen, Niedersachsen 37075
    Germany

    Site Not Available

  • Local Institution - 0020

    Bad Nauheim, 61231
    Germany

    Site Not Available

  • Local Institution - 0020

    Bad Nauheim 2953395, 61231
    Germany

    Site Not Available

  • Local Institution - 0018

    Dresden, 01277
    Germany

    Site Not Available

  • Local Institution - 0018

    Dresden 2935022, 01277
    Germany

    Site Not Available

  • Local Institution - 0019

    Goettingen, 37075
    Germany

    Site Not Available

  • Local Institution - 0019

    Göttingen 2918632, 37075
    Germany

    Site Not Available

  • Local Institution - 0021

    Heidelberg, 69120
    Germany

    Site Not Available

  • Local Institution - 0021

    Heidelberg 2907911, 69120
    Germany

    Site Not Available

  • Local Institution - 0027

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Local Institution - 0027

    Jerusalem 281184, 9112001
    Israel

    Site Not Available

  • Local Institution - 0024

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Local Institution - 0024

    Petah Tikva 293918, 4941492
    Israel

    Site Not Available

  • Sheba Medical Center - PPDS

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Local Institution - 0022

    Ramat Gan 293788, 52621
    Israel

    Site Not Available

  • Local Institution - 0022

    Ramat-gan, 52621
    Israel

    Site Not Available

  • Local Institution - 0025

    Rehovot, 76100
    Israel

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  • Local Institution - 0025

    Rehovot 293725, 76100
    Israel

    Site Not Available

  • Local Institution - 0023

    Safed, 13100
    Israel

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  • Local Institution - 0023

    Safed 293100, 13100
    Israel

    Site Not Available

  • Local Institution - 0026

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Local Institution - 0026

    Tel Aviv 293397, 6423906
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center PPDS

    Tel-Aviv, 64239
    Israel

    Site Not Available

  • Local Institution - 0028

    Firenze, 50139
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi

    Florence,
    Italy

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  • Local Institution - 0028

    Florence 3176959, 50139
    Italy

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  • Local Institution - 0029

    Maastricht, 6229 HX
    Netherlands

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  • Local Institution - 0029

    Maastricht 2751283, 6229 HX
    Netherlands

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  • Local Institution - 0030

    Rotterdam, 3015 CE
    Netherlands

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  • Local Institution - 0030

    Rotterdam 2747891, 3015 CE
    Netherlands

    Site Not Available

  • Collegium Medicum Uniwersytetu Jagiellonskiego

    Kraków, Malopolskie 31-501
    Poland

    Site Not Available

  • Szpital Kliniczny Przemienienia Panskiego Uniwesytetu Medycznego im. Karola Marcinkowskiego

    Poznań, Wielkopolskie 61-848
    Poland

    Site Not Available

  • Local Institution - 0033

    Katowice, 40-555
    Poland

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  • Local Institution - 0033

    Katowice 3096472, 40-555
    Poland

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  • Local Institution - 0034

    Krakow, 31-501
    Poland

    Site Not Available

  • Local Institution - 0034

    Krakow 3094802, 31-501
    Poland

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  • Local Institution - 0031

    Poznan, 61-848
    Poland

    Site Not Available

  • Local Institution - 0031

    Poznan 3088171, 61-848
    Poland

    Site Not Available

  • Local Institution - 0032

    Warsaw, 04-628
    Poland

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  • Local Institution - 0032

    Warsaw 756135, 04-628
    Poland

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  • Local Institution - 0036

    Almada, 2805-267
    Portugal

    Site Not Available

  • Local Institution - 0036

    Almada 2271961, 2805-267
    Portugal

    Site Not Available

  • Local Institution - 0035

    Lisboa, 1500-650
    Portugal

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  • Local Institution - 0035

    Lisbon 2267057, 1500-650
    Portugal

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  • Local Institution - 0038

    A Coruña, 15006
    Spain

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  • Local Institution - 0038

    A Coruña 3119841, 15006
    Spain

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  • Local Institution - 0037

    El Palmar, 30120
    Spain

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  • Local Institution - 0037

    El Palmar 2518293, 30120
    Spain

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  • Local Institution - 0040

    Madrid, 28034
    Spain

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  • Local Institution - 0040

    Madrid 3117735, 28034
    Spain

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  • Local Institution - 0039

    Majadahonda, 28222
    Spain

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  • Local Institution - 0039

    Majadahonda 3117667, 28222
    Spain

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  • Local Institution - 0041

    Sevilla, 41009
    Spain

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  • Local Institution - 0041

    Seville 2510911, 41009
    Spain

    Site Not Available

  • Local Institution - 0042

    London, W1G 8PH
    United Kingdom

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  • Local Institution - 0042

    London 2643743, W1G 8PH
    United Kingdom

    Site Not Available

  • Mayo Clinic Arizona

    Phoenix, Arizona 85054
    United States

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  • Local Institution - 0045

    Scottsdale, Arizona 85259
    United States

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  • Local Institution - 0045

    Scottsdale 5313457, Arizona 5551752 85259
    United States

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  • Local Institution - 0058

    Los Angeles, California 90027
    United States

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  • Local Institution - 0066

    San Francisco, California 94143
    United States

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  • Local Institution - 0063

    Stanford, California 94305
    United States

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  • Local Institution - 0058

    Los Angeles 5368361, California 5332921 90027
    United States

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  • Local Institution - 0066

    San Francisco 5391959, California 5332921 94143
    United States

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  • Local Institution - 0063

    Stanford 5398563, California 5332921 94305
    United States

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  • Local Institution - 0043

    New Haven, Connecticut 06520-8017
    United States

    Site Not Available

  • Local Institution - 0043

    New Haven 4839366, Connecticut 4831725 06520-8017
    United States

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  • Local Institution - 0067

    Jacksonville, Florida 32224
    United States

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  • Local Institution - 0067

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • Local Institution - 0050

    Chicago, Illinois 60611
    United States

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  • Local Institution - 0050

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Local Institution - 0070

    Indianapolis, Indiana 46260
    United States

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  • Local Institution - 0070

    Indianapolis 4259418, Indiana 4921868 46260
    United States

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  • Local Institution - 0049

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Local Institution - 0049

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • Local Institution - 0054

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Local Institution - 0054

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Local Institution - 0051

    Ann Arbor, Michigan 48109
    United States

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  • Local Institution

    Detroit, Michigan 48202
    United States

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  • Local Institution - 0074

    Grand Rapids, Michigan 49503
    United States

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  • Local Institution - 0051

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

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  • Local Institution - 0074

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

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  • Local Institution - 0048

    Saint Louis, Missouri 63110
    United States

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  • Local Institution - 0048

    St Louis 4407066, Missouri 4398678 63110
    United States

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  • Local Institution - 0056

    New York, New York 10032
    United States

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  • Local Institution - 0060

    New York, New York 10016
    United States

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  • Local Institution - 0056

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Local Institution - 0060

    New York 5128581, New York 5128638 10016
    United States

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  • Local Institution - 0071

    Charlotte, North Carolina 28204
    United States

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  • Local Institution - 0047

    Durham, North Carolina 27710
    United States

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  • Local Institution - 0071

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Local Institution - 0047

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Local Institution - 0052

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Local Institution - 0052

    Cincinnati 4508722, Ohio 5165418 45267
    United States

    Site Not Available

  • Local Institution - 0044

    Portland, Oregon 97239
    United States

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  • Local Institution - 0044

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Local Institution - 0068

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • St. Luke's University Health Network

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Local Institution - 0046

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Local Institution - 0064

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Local Institution - 0068

    Bethlehem 5180225, Pennsylvania 6254927 18015
    United States

    Site Not Available

  • Local Institution - 0046

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Local Institution - 0064

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Local Institution - 0073

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • Local Institution - 0073

    Memphis 4641239, Tennessee 4662168 38104
    United States

    Site Not Available

  • Local Institution - 0061

    Dallas, Texas 75390
    United States

    Site Not Available

  • Local Institution - 0055

    Houston, Texas 77030
    United States

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  • Local Institution - 0057

    Houston, Texas 77030
    United States

    Site Not Available

  • Local Institution - 0061

    Dallas 4684888, Texas 4736286 75390
    United States

    Site Not Available

  • Local Institution - 0055

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Local Institution - 0057

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Local Institution - 0072

    Murray, Utah 84107-5701
    United States

    Site Not Available

  • Local Institution - 0062

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Local Institution - 0072

    Murray 5778755, Utah 5549030 84107-5701
    United States

    Site Not Available

  • Local Institution - 0062

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Site Not Available

  • Local Institution - 0053

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Local Institution - 0059

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Local Institution - 0053

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

  • Local Institution - 0059

    Richmond 4781708, Virginia 6254928 23298
    United States

    Site Not Available

  • Local Institution - 0065

    Seattle, Washington 98195
    United States

    Site Not Available

  • Local Institution - 0065

    Seattle 5809844, Washington 5815135 98195
    United States

    Site Not Available

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