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Abatacept in Immune Checkpoint Inhibitor Myocarditis (ATRIUM)

Primary Purpose

Myocarditis Acute, Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abatacept plus
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocarditis Acute focused on measuring Immune checkpoint Inhibitor, Myocarditis, Abatacept, Immune therapy, Immune related adverse events

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Must have provided informed consent in a manner approved by the Investigator's Institutional Review Board (IRB) prior to any study-related procedure being performed. If a participant is unable to provide informed consent due to his/her medical condition, the participant's legally authorized representative may consent on behalf of the study participant, as permitted by local law and institutional Standard Operating Procedures;
  2. Aged greater than or equal to 18 years at the time of informed consent;
  3. Recent use of an FDA-approved immune checkpoint inhibitor (ICI, defined as administered an immune checkpoint inhibitor ≤ 6 months of myocarditis diagnosis), alone or in combination with other cancer therapies (i.e. chemotherapy, radiation therapy or targeted therapy). The FDA-approved ICI could be given as part of a clinical trial but not in combination with a new investigational agent which may cause myocarditis;
  4. A diagnosis of myocarditis.
  5. Hospitalized at the time of randomization;
  6. On 1000 mg of solumedrol per day for myocarditis or with an intent to initiate 1000 mg of solumedrol per day for myocarditis within 24 hours of first administration of study drug;
  7. Serum evidence of ongoing myocardial injury: Serum evidence of ongoing myocardial injury will be defined as an institutional troponin (either conventional or high-sensitivity troponin I or T, using the standard institutional assay) with a value that is ≥5 times the upper limit of the reference standard normal for that institution. The troponin assay may be adjusted based on sex depending on institutional standards. This value of troponin of ≥5 times above the institutional upper limits of normal value must be noted within 10 days prior to potential randomization. The 10-day period can be in the outpatient or inpatient setting. For example, a participant with a troponin value that on one occasion was ≥5 times the upper limits of institutional normal in the 10-day window prior to potential randomization (whether in the inpatient or outpatient setting), but later decreases below that threshold, typically due to starting corticosteroids, would still be considered eligible;
  8. The following laboratory parameters, not older than 48 hours at the time of randomization, and measured as part of usual care:

    • Total white blood cell (WBC) count >2,500/μl
    • Absolute neutrophil count (ANC) >1,500/μL
    • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <20 times the upper limit of the institutional normal ranges;
  9. Women of childbearing potential (i.e., not postmenopausal, or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test prior to randomization. Participating women of childbearing potential must be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug. Participating men must also be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug; and
  10. Must be willing and able to abide by all study requirements and restrictions.

Exclusion Criteria:

  1. Must not have experienced any of the following (as defined in the section on the primary endpoint) in the 30-day period prior to randomization:

    • A sudden cardiac arrest
    • Cardiogenic shock as defined. A significant bradyarrhythmia (Mobitz type II second degree atrioventricular block or third degree (complete) atrio-ventricular (AV) block, for which an intervention with a temporary or permanent pacemaker is completed or recommended).
    • A significant tachyarrhythmia (ventricular fibrillation of any duration or sustained ventricular tachycardia (>30 seconds, >120 beats per minute); or a ventricular tachyarrhythmia requiring intervention.
  2. Recent (≤2 month) exposure to abatacept or belatacept.
  3. Concurrent or recent (≤2 month) use of the following non-corticosteroid immunosuppressive therapies prior to randomization: mycophenolate, JAK STAT inhibitors (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib), tacrolimus, anti-thymocyte globulin, alemtuzumab, infliximab, and plasma exchange. The use of intravenous immunoglobulin is permitted prior to randomization and during study treatment.
  4. Currently enrolled in another interventional study utilizing systemic agents for the management of ICI-related toxicities.
  5. Female who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 90 days after the last dose of study drug.
  6. Male who is considering fathering a child or donating sperm during the study or for approximately 30 days after the last dose of study drug.
  7. Any active, chronic, or recurrent viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study. These may include hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a single episode) herpes zoster, and disseminated (even a single episode) herpes simplex. Active HBV and HCV are defined as: HBV: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for Hepatitis B core antibody (HBc Ab) positive (+) participants; HCV: HCV ribonucleic acid (RNA) detectable in any participant with anti-HCV antibody (HCV Ab). Patients with active Covid-19 infection will be excluded. This is defined as the period of ongoing symptoms in the setting of a positive Covid-19 test, or until 10 days after symptom onset and after resolution of fever for at least 24 hours, without the use of fever-reducing medications.
  8. Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections;
  9. Receipt of any live vaccine within four weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 90 days after the last dose of IV study drug.
  10. Any medical condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the Investigator, increase the risk of the participant by participating in the study.
  11. Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting
  • University of California Los AngelesRecruiting
  • MedStar Health Research Institute, Georgetown UniversityRecruiting
  • Moffitt Cancer CenterRecruiting
  • University of ChicagoRecruiting
  • Franciscan HealthRecruiting
  • University of Kansas Medical CenterRecruiting
  • University of KentuckyRecruiting
  • Maine HealthRecruiting
  • Johns HopkinsRecruiting
  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • Boston Medical CenterRecruiting
  • Brigham and Women's HospitalRecruiting
  • University of MichiganRecruiting
  • Mayo ClinicRecruiting
  • Robert Wood Johnson University HospitalRecruiting
  • Columbia University Irving Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • University of North Carolina Chapel HillRecruiting
  • Cleveland ClinicRecruiting
  • Lehigh Valley Health NetworkRecruiting
  • University of PennsylvaniaRecruiting
  • Allegheny-Singer Research InstitutionRecruiting
  • University of Texas SouthwesternRecruiting
  • MD Anderson Cancer Center
  • University of UtahRecruiting
  • University of West VirginiaRecruiting
  • Aurora St Luke's Medical CenterRecruiting
  • University of British ColombiaRecruiting
  • McMaster UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Abatacept plus standard of care

Placebo plus standard of care

Arm Description

Abatacept (10 mg/kg) will be administered IV after randomization, again at 24 hours after first study drug treatment, at 14 days after first study drug treatment and an optional 4th dose at 28 days.

Placebo will be administered at the same intervals.

Outcomes

Primary Outcome Measures

Major adverse cardiac events
The rates of a composite of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure.

Secondary Outcome Measures

The individual components of the primary endpoint.
The rates of the following between groups: cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure
Myocarditis illness severity using a 7-point ordinal severity scale containing each of the individual endpoints in a hierarchical ranking order.
The worst score on a 7-point ordinal myocarditis severity scale during the 6 month period from first study treatment. The 7-point ordinal myocarditis severity scale is as follows with more severe outcomes ranked with a higher number: - No component of the primary endpoint; - Incident heart failure; - Significant bradyarrhythmia; - Significant ventricular tachyarrhythmias; - Cardiogenic shock; - Sudden cardiac arrest; - Cardiovascular death;
The increase in serum troponin levels
The proportion of participants in each group with a >50% increase in serum troponin value at any time during the incident hospitalization and following administration of study drug.
The combination of the rates of the primary outcome plus the proportion of patients with a troponin increase.
The rates of a composite of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure plus the proportion of participants in each group with a >50% increase in serum troponin value at any time during the incident hospitalization and following administration of study drug.
Clinical status at 90 days after first infusion of study drug
Clinical status at visit 6 (day 90) on an ordinal scale with highest being the worst: - Alive and off corticosteroids for myocarditis; - Alive and on corticosteroids (provide dose) for myocarditis; - Alive and on cellcept (provide dose) for myocarditis; - Alive and on both corticosteroids (provide dose) and cellcept (provide dose) for myocarditis - Dead (cancer, cardiovascular or other).
Clinical status at 6 months after first infusion of study drug
Clinical status at visit 7 (6 months) with the highest being the worst: - Alive and off corticosteroids for myocarditis; - Alive and on corticosteroids (provide dose) for myocarditis; - Alive and on cellcept (provide dose) for myocarditis; - Alive and on both corticosteroids (provide dose) and cellcept (provide dose) for myocarditis - Dead (cancer, cardiovascular or other).
Fatal and non-fatal DVT and PE
The proportion of patients in each group with a fatal and non-fatal DVT and PE will be compared.
Other immune-related adverse events between the two groups
Rates of other immune-related adverse events between the two groups will be compared.

Full Information

First Posted
April 5, 2022
Last Updated
September 6, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05335928
Brief Title
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Acronym
ATRIUM
Official Title
AbatacepT foR ImmUne Checkpoint Inhibitor Associated Myocarditis (ATRIUM): A Phase 3, Investigator-Initiated, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in ICI Myocarditis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure.
Detailed Description
This investigator-initiated randomized trial is being conducted to test whether abatacept, as compared to placebo, is associated with a reduction in MACE among participants who develop myocarditis after treatment with an ICI. Immune checkpoint inhibitors leverage the immune system to treat a wide variety of cancers. Myocarditis is an uncommon immune related adverse event (irAE) secondary to treatment with an ICI. The guideline recommended treatment for ICI myocarditis is cessation of the ICI and administration of corticosteroids. However, despite administration of corticosteroids, the rate of MACE with ICI myocarditis is high. Data from multiple independent international cohorts have shown that the rate of MACE with ICI myocarditis despite administration of corticosteroids ranges from 25-50%.For comparison, the rate of MACE with myocarditis unrelated to an ICI is <5%. Abatacept is a selective co-stimulation modulator that inhibits T cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking its interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes. In animal studies of ICI myocarditis, the administration of abatacept led to a reduction in cardiac immune activation and an increase in survival. In retrospective unpublished clinical data, the administration of abatacept to participants with ICI myocarditis on corticosteroids was associated with a reduction in risk of MACE. There are no prospective studies testing whether abatacept is effective among participants with ICI myocarditis. Therefore, the primary aim of this trial is to test in a randomized double-blind placebo-controlled study whether abatacept, administered concurrently with corticosteroids, is associated with a reduction in MACE among participants with recently diagnosed ICI myocarditis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocarditis Acute, Cancer
Keywords
Immune checkpoint Inhibitor, Myocarditis, Abatacept, Immune therapy, Immune related adverse events

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abatacept plus standard of care
Arm Type
Experimental
Arm Description
Abatacept (10 mg/kg) will be administered IV after randomization, again at 24 hours after first study drug treatment, at 14 days after first study drug treatment and an optional 4th dose at 28 days.
Arm Title
Placebo plus standard of care
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered at the same intervals.
Intervention Type
Drug
Intervention Name(s)
Abatacept plus
Other Intervention Name(s)
Orencia
Intervention Description
Up to 4 study drug infusions at 10 mg/kg, IV Drug: Standard of care Local standard of care per written policies or guidelines Other Name: SoC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Drug: Standard of care Local standard of care per written policies or guidelines Other Name: SoC
Primary Outcome Measure Information:
Title
Major adverse cardiac events
Description
The rates of a composite of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The individual components of the primary endpoint.
Description
The rates of the following between groups: cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure
Time Frame
6 months
Title
Myocarditis illness severity using a 7-point ordinal severity scale containing each of the individual endpoints in a hierarchical ranking order.
Description
The worst score on a 7-point ordinal myocarditis severity scale during the 6 month period from first study treatment. The 7-point ordinal myocarditis severity scale is as follows with more severe outcomes ranked with a higher number: - No component of the primary endpoint; - Incident heart failure; - Significant bradyarrhythmia; - Significant ventricular tachyarrhythmias; - Cardiogenic shock; - Sudden cardiac arrest; - Cardiovascular death;
Time Frame
6 months
Title
The increase in serum troponin levels
Description
The proportion of participants in each group with a >50% increase in serum troponin value at any time during the incident hospitalization and following administration of study drug.
Time Frame
6 months
Title
The combination of the rates of the primary outcome plus the proportion of patients with a troponin increase.
Description
The rates of a composite of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure plus the proportion of participants in each group with a >50% increase in serum troponin value at any time during the incident hospitalization and following administration of study drug.
Time Frame
6 months
Title
Clinical status at 90 days after first infusion of study drug
Description
Clinical status at visit 6 (day 90) on an ordinal scale with highest being the worst: - Alive and off corticosteroids for myocarditis; - Alive and on corticosteroids (provide dose) for myocarditis; - Alive and on cellcept (provide dose) for myocarditis; - Alive and on both corticosteroids (provide dose) and cellcept (provide dose) for myocarditis - Dead (cancer, cardiovascular or other).
Time Frame
6 months
Title
Clinical status at 6 months after first infusion of study drug
Description
Clinical status at visit 7 (6 months) with the highest being the worst: - Alive and off corticosteroids for myocarditis; - Alive and on corticosteroids (provide dose) for myocarditis; - Alive and on cellcept (provide dose) for myocarditis; - Alive and on both corticosteroids (provide dose) and cellcept (provide dose) for myocarditis - Dead (cancer, cardiovascular or other).
Time Frame
6 months
Title
Fatal and non-fatal DVT and PE
Description
The proportion of patients in each group with a fatal and non-fatal DVT and PE will be compared.
Time Frame
6 months
Title
Other immune-related adverse events between the two groups
Description
Rates of other immune-related adverse events between the two groups will be compared.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have provided informed consent in a manner approved by the Investigator's Institutional Review Board (IRB) prior to any study-related procedure being performed. If a participant is unable to provide informed consent due to his/her medical condition, the participant's legally authorized representative may consent on behalf of the study participant, as permitted by local law and institutional Standard Operating Procedures; Aged greater than or equal to 18 years at the time of informed consent; Recent use of an FDA-approved immune checkpoint inhibitor (ICI, defined as administered an immune checkpoint inhibitor ≤ 6 months of myocarditis diagnosis), alone or in combination with other cancer therapies (i.e. chemotherapy, radiation therapy or targeted therapy). The FDA-approved ICI could be given as part of a clinical trial but not in combination with a new investigational agent which may cause myocarditis; A diagnosis of myocarditis. Hospitalized at the time of randomization; On 1000 mg of solumedrol per day for myocarditis or with an intent to initiate 1000 mg of solumedrol per day for myocarditis within 24 hours of first administration of study drug; Serum evidence of ongoing myocardial injury: Serum evidence of ongoing myocardial injury will be defined as an institutional troponin (either conventional or high-sensitivity troponin I or T, using the standard institutional assay) with a value that is ≥5 times the upper limit of the reference standard normal for that institution. The troponin assay may be adjusted based on sex depending on institutional standards. This value of troponin of ≥5 times above the institutional upper limits of normal value must be noted within 10 days prior to potential randomization. The 10-day period can be in the outpatient or inpatient setting. For example, a participant with a troponin value that on one occasion was ≥5 times the upper limits of institutional normal in the 10-day window prior to potential randomization (whether in the inpatient or outpatient setting), but later decreases below that threshold, typically due to starting corticosteroids, would still be considered eligible; The following laboratory parameters, not older than 48 hours at the time of randomization, and measured as part of usual care: Total white blood cell (WBC) count >2,500/μl Absolute neutrophil count (ANC) >1,500/μL Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <20 times the upper limit of the institutional normal ranges; Women of childbearing potential (i.e., not postmenopausal, or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test prior to randomization. Participating women of childbearing potential must be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug. Participating men must also be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug; and Must be willing and able to abide by all study requirements and restrictions. Exclusion Criteria: Must not have experienced any of the following (as defined in the section on the primary endpoint) in the 30-day period prior to randomization: A sudden cardiac arrest Cardiogenic shock as defined. A significant bradyarrhythmia (Mobitz type II second degree atrioventricular block or third degree (complete) atrio-ventricular (AV) block, for which an intervention with a temporary or permanent pacemaker is completed or recommended). A significant tachyarrhythmia (ventricular fibrillation of any duration or sustained ventricular tachycardia (>30 seconds, >120 beats per minute); or a ventricular tachyarrhythmia requiring intervention. Recent (≤2 month) exposure to abatacept or belatacept. Concurrent or recent (≤2 month) use of the following non-corticosteroid immunosuppressive therapies prior to randomization: mycophenolate, JAK STAT inhibitors (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib), tacrolimus, anti-thymocyte globulin, alemtuzumab, infliximab, and plasma exchange. The use of intravenous immunoglobulin is permitted prior to randomization and during study treatment. Currently enrolled in another interventional study utilizing systemic agents for the management of ICI-related toxicities. Female who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 90 days after the last dose of study drug. Male who is considering fathering a child or donating sperm during the study or for approximately 30 days after the last dose of study drug. Any active, chronic, or recurrent viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study. These may include hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a single episode) herpes zoster, and disseminated (even a single episode) herpes simplex. Active HBV and HCV are defined as: HBV: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for Hepatitis B core antibody (HBc Ab) positive (+) participants; HCV: HCV ribonucleic acid (RNA) detectable in any participant with anti-HCV antibody (HCV Ab). Patients with active Covid-19 infection will be excluded. This is defined as the period of ongoing symptoms in the setting of a positive Covid-19 test, or until 10 days after symptom onset and after resolution of fever for at least 24 hours, without the use of fever-reducing medications. Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections; Receipt of any live vaccine within four weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 90 days after the last dose of IV study drug. Any medical condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the Investigator, increase the risk of the participant by participating in the study. Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah K Gilman, MS
Phone
6177261019
Email
hkgilman@mgh.harvard.edu
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
02127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiranbir Josan, MD
First Name & Middle Initial & Last Name & Degree
Kiranbir Josan, MD
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Yang, MD
First Name & Middle Initial & Last Name & Degree
Eric Yang, MD
Facility Name
MedStar Health Research Institute, Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hayder Hashim
First Name & Middle Initial & Last Name & Degree
Hayder Hashim
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed v
First Name & Middle Initial & Last Name & Degree
Mohammed Alomar
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanne DeCara
First Name & Middle Initial & Last Name & Degree
Jeanne DeCara
Facility Name
Franciscan Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Daly
First Name & Middle Initial & Last Name & Degree
Ryan Daly, MD
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Porter
First Name & Middle Initial & Last Name & Degree
Charles Porter, MD
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0200
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Arbune
First Name & Middle Initial & Last Name & Degree
Amit Arbune, MD
Facility Name
Maine Health
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxwell Afari
First Name & Middle Initial & Last Name & Degree
Maxwell Afari, MD
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joban Vaishnav
First Name & Middle Initial & Last Name & Degree
Joban Vaishnav
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Zlotoff, MD, PhD
Phone
617-726-2000
Email
dzlotoff@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Kerry Reynolds, MD
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abul Aritizia, MD
First Name & Middle Initial & Last Name & Degree
Aarti Asnani, MD
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Siddiqi
First Name & Middle Initial & Last Name & Degree
Omar Siddiqi, MD
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anju Nohria, MD
Email
ANOHRIA@PARTNERS.ORG
First Name & Middle Initial & Last Name & Degree
Anju Nohria, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salim Hayek, MD
Email
shayek@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Salim Hayek, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joerg Herrmann
First Name & Middle Initial & Last Name & Degree
Joerg Herrmann, MD
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amna Zafar
First Name & Middle Initial & Last Name & Degree
Amna Zafar
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayant Raikhelkar
First Name & Middle Initial & Last Name & Degree
Jayant Raikhelkar
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dipti Gupta, MD
First Name & Middle Initial & Last Name & Degree
Dipti Gupta, MD
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Jensen, MD
First Name & Middle Initial & Last Name & Degree
Brian Jensen, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Moudgil
First Name & Middle Initial & Last Name & Degree
Rohit Moudgil
Facility Name
Lehigh Valley Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Trask
First Name & Middle Initial & Last Name & Degree
Deborah Sundlof
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Fradley
First Name & Middle Initial & Last Name & Degree
Michael Fradley
Facility Name
Allegheny-Singer Research Institution
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentyna Ivanova
First Name & Middle Initial & Last Name & Degree
Ivanova Ivanova, MD
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
72535
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saketh Nadimpalli
Email
Saketh.Nadimpalli@UTSouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Vlad Zaha, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Palaskas
Email
NLPalaskas@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Nicolas Palaskas, MD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anees Daud, MD
First Name & Middle Initial & Last Name & Degree
Anees Daud, MD
Facility Name
University of West Virginia
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brijesh Patel
First Name & Middle Initial & Last Name & Degree
Brijesh Patel, MD
Facility Name
Aurora St Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manmeet Singh
First Name & Middle Initial & Last Name & Degree
Manmeet Singh
Facility Name
University of British Colombia
City
Vancouver
State/Province
British Colombia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margot Davis
First Name & Middle Initial & Last Name & Degree
Margot Davis, MD
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darryl Leong
First Name & Middle Initial & Last Name & Degree
Darryl Leong, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Abatacept in Immune Checkpoint Inhibitor Myocarditis

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