What side effects are associated with this type of intervention?

Common treatments for cancer that are similar to abatacept, such as other biologics and immune checkpoint inhibitors, have a range of side effects. These can include an increased risk of infections, as the immune system is modulated or suppressed. Specific side effects for immune checkpoint inhibitors can include myocarditis, which is inflammation of the heart muscle, and other immune-related adverse events such as colitis, hepatitis, and endocrinopathies. For biologics like abatacept, there is a slight but statistically significant increase in the risk of total malignancies, including lung cancer, lymphoma, and breast cancer. Additionally, these treatments can cause infusion-related reactions and general symptoms like fatigue, fever, and gastrointestinal disturbances.

What prior FDA approvals exist?

The FDA has approved various immune-modulating drugs for cancer treatment, including immune checkpoint inhibitors like pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways to enhance the immune response against cancer cells. These drugs have shown efficacy in treating several types of cancer, including non-small cell lung cancer and melanoma. Additionally, the FDA has utilized accelerated pathways to approve new cancer drugs based on surrogate endpoints and preliminary data, ensuring faster access to promising therapies. While specific details on drugs similar to abatacept are limited, the general trend in FDA approvals highlights a focus on innovative immune-based treatments for cancer.

What other types of research exist?

Promising novel alternatives to Abatacept for cancer patients include kinase inhibitors (CDK, PDK1/AKT, PKC), DNA methyltransferase inhibitors, histone deacetylase inhibitors, chimeric antigen receptor (CAR) T cells, bispecific T cell engagers (BiTEs), and agents targeting cereblon (CELMoDs). Specific examples include idecabtagene vicleucel, ciltacabtagene autoleucel, teclistamab, AMG 701, iberdomide, CC92480, talquetamab, cevostamab, filanesib, dinaciclib, and LGH-447.

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Immunomodulator

Abatacept for Myocarditis (ATRIUM Trial)

Phase 3

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized at the time of randomization

A diagnosis of myocarditis

Must not have

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

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, A significant tachyarrhythmia, Recent (≤2 month) exposure to abatacept or belatacept

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Pivotal Trial

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

This Trial tests if abatacept can reduce serious heart problems in patients with heart inflammation caused by cancer treatments. Abatacept calms the immune system by preventing certain immune cells from becoming fully active, reducing inflammation and damage. Abatacept has been approved by the US Food and Drug Administration for the treatment of rheumatoid arthritis, with or without methotrexate.

Who is the study for?

Adults hospitalized with myocarditis caused by recent immune checkpoint inhibitor therapy for cancer, who are on or starting high-dose corticosteroids. Participants must have certain blood cell counts within normal ranges, not be pregnant or breastfeeding, and agree to use contraception. Exclusions include active infections like TB, recent live vaccines, other immunosuppressive treatments, and participation in another interventional study.

What is being tested?

The trial is testing if abatacept can reduce major cardiac events compared to a placebo in patients with myocarditis following cancer treatment with immune checkpoint inhibitors. The main outcome measures include cardiovascular death and various heart-related complications.

What are the potential side effects?

Potential side effects of abatacept may include increased risk of infections due to immune system suppression, possible allergic reactions at the injection site or throughout the body, headache, nausea, and potential worsening of any current infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently in the hospital.

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I have been diagnosed with myocarditis.

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I am 18 years old or older.

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I am taking or about to take 1000 mg of solumedrol daily for heart inflammation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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I haven't had major heart issues or used specific drugs in the last 2 months.

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I do not have active or untreated TB or any suspected serious infections.

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I haven't had a live vaccine in the last 4 weeks and don't plan to during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Major adverse cardiac events

Secondary study objectives

Clinical status at 6 months after first infusion of study drug

Clinical status at 90 days after first infusion of study drug

Fatal and non-fatal DVT and PE

+5 more

Side effects data

From 2016 Phase 4 trial • 3 Patients • NCT02078193

67%

COPD exacerbation

100%

80%

60%

40%

20%

Study treatment Arm

Belatacept

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Abatacept plus standard of careExperimental Treatment1 Intervention

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.

Group II: Placebo plus standard of carePlacebo Group1 Intervention

Placebo will be administered at the same intervals.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immunotherapies, such as abatacept, work by modulating the immune system to enhance its ability to fight cancer. Abatacept specifically targets T-cell activation pathways, reducing the immune response that can lead to adverse cardiac events in patients treated with immune checkpoint inhibitors. This mechanism is crucial for cancer patients as it helps manage immune-related side effects while maintaining the therapeutic benefits of immunotherapy. Other common treatments include checkpoint inhibitors that block proteins like PD-1, allowing T-cells to attack cancer cells more effectively. These therapies are significant because they offer targeted approaches to boost the body's natural defenses against cancer, potentially leading to better outcomes and fewer side effects compared to traditional treatments.

The Novel Therapeutic Landscape for Relapsed/Refractory Diffuse Large B Cell Lymphoma.Utilization of Chimeric Antigen Receptor T-cell Therapy in Adults.Immune Profiling of Cancer Patients Treated with Immunotherapy: Advances and Challenges.