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Monoclonal Antibodies

Infliximab + IVIG for Pneumonitis

Phase 2

Waitlist Available

Led By Jarushka Naidoo

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

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

Must have

Patient must have had a pathogen-negative bronchoscopic assessment of BAL fluid within 14 days prior to randomization. A minimum assessment for pathogens on BAL must include: gram stain, fungal panel, viral panel

- Grade 3 or higher pneumonitis that has not clinically improved by a CTCAE grade in greater than 48 hours or maximum of 14 days with high dose corticosteroids (methylprednisolone or prednisone 1-4 mg/kg/equivalent) as their most recent treatment for pneumonitis, as determined by the treating investigator

Must not have

Patient must not be receiving concurrent radiation therapy to the chest

Patient must not have pre-existing interstitial lung disease or pneumonitis requiring corticosteroid therapy from any other cause, as determined by the treating investigator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at days 1, 14, and 28

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new immunotherapy treatment for pneumonitis that has not responded to steroids. The treatment consists of two parts: a monoclonal antibody called infliximab, and intravenous immunoglobulin therapy. It is not yet known whether this new treatment is more effective than existing treatments.

Who is the study for?

This trial is for patients with pneumonitis that hasn't improved after steroid treatment. They must have used anti-PD-1/PD-L1 therapy recently, can have any type of cancer, and need to be in a stable condition (ECOG 0-3). Participants should not be pregnant or breastfeeding, must use contraception if needed, and cannot have certain infections or lung diseases.

What is being tested?

The study is testing whether infliximab combined with intravenous immunoglobulin therapy works better than current treatments for steroid-refractory pneumonitis. Infliximab is an antibody that might change the immune system's response to tumors; IVIG may improve inflammation in the lungs.

What are the potential side effects?

Possible side effects include allergic reactions to infliximab or IVIG, risk of infection due to weakened immunity, potential liver issues like hepatitis B reactivation, and general discomfort from infusion such as headaches or nausea.

Eligibility Criteria

Inclusion Criteria

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

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My recent lung test showed no infection.

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My severe lung inflammation hasn't improved despite recent high-dose steroid treatment.

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I am not pregnant or breastfeeding.

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My lung inflammation hasn't improved with steroid treatment.

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I was treated with an anti-PD-1/PD-L1 agent before getting pneumonitis.

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I can care for myself but may not be able to do heavy physical work.

Exclusion Criteria

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

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I am not currently undergoing radiation therapy to the chest.

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I do not have lung conditions needing steroids.

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I am not on anti-PD-1/-PD-L1 therapy combined with specific cancer drugs.

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I don't have severe allergies, certain infections, or conditions that IVIG or infliximab would worsen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at days 1, 14, and 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at days 1, 14, and 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and at days 1, 14, and 28 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pneumonitis Response Rate

Secondary study objectives

Functional Parameters of Steroid-refractory Pneumonitis by Diffusion Capacity

Functional Parameters of Steroid-refractory Pneumonitis by Oxygen Saturation

Functional Parameters of Steroid-refractory Pneumonitis by Spirometry

+4 more

Other study objectives

Distribution of Biomarkers in Patients Who Develop Steroid-refractory Pneumonitis

To Evaluate Associations Between Pneumonitis and Autoantibodies, T Cell Expansion, and Baseline Cytokines in the Blood

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (intravenous immunoglobulin therapy)Experimental Treatment3 Interventions

Patients receive intravenous immunoglobulin therapy IV over 2-5 days per institutional guidelines followed by prednisone taper IV or PO for 4-6 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (infliximab)Experimental Treatment3 Interventions

Patients receive infliximab IV on day 1 followed by prednisone taper IV or PO for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive an additional dose of infliximab IV on day 14 at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylprednisolone

2015

Completed Phase 4

~2280

Infliximab

2017

Completed Phase 4

~3350