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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

Patient must have a negative tuberculosis assessment (TB spot test, quantiferon gold or tuberculin skin test) within 14 days prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at days 1, 14, and 28

Awards & highlights

Study 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.Check my eligibility

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.See study design

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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I tested negative for tuberculosis within the last 14 days.

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

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I have received anti-PD-1/PD-L1 therapy before.

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I've had recent tests showing no infection in my blood, urine, or lungs.

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I am using or willing to use effective birth control or abstain from sex for at least 56 days.

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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 am willing to have a test that measures the oxygen and carbon dioxide levels in my blood.

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I have a solid tumor or blood cancer.

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I have had previous treatments for my condition.

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

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My lung inflammation hasn't improved in over 72 hours.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pneumonitis Response Rate

Secondary outcome measures

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 outcome measures

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

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

Infliximab

2017

Completed Phase 4

~3280

Methylprednisolone

2015

Completed Phase 4

~2280

Prednisone

2014

Completed Phase 4

~2370

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,921 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,666 Total Patients Enrolled

2 Trials studying Pneumonitis

17 Patients Enrolled for Pneumonitis

Jarushka NaidooPrincipal InvestigatorECOG-ACRIN Cancer Research Group

1 Previous Clinical Trials

68 Total Patients Enrolled

Media Library

Infliximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04438382 — Phase 2

Pneumonitis Research Study Groups: Arm A (infliximab), Arm B (intravenous immunoglobulin therapy)

Pneumonitis Clinical Trial 2023: Infliximab Highlights & Side Effects. Trial Name: NCT04438382 — Phase 2

Infliximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04438382 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what ailments is Intravenous Immunoglobulin Therapy commonly prescribed?

"Intravenous Immunoglobulin Therapy is an oft-used treatment for scalp structure, and also has applications with regards to thyroiditis, psoriasis, and ulcerative colitis."

Answered by AI

Is recruitment for this clinical trial still ongoing?

"Per the data on clinicaltrials.gov, this research is presently accepting participants. The investigation was originally published on July 1st 2021 and most recently amended on August 10th 2022."

Answered by AI

To what extent has Intravenous Immunoglobulin Therapy been studied in past clinical trials?

"Intravenous Immunoglobulin Therapy began its tenure in the scientific world at Providence Cancer Center, and since then 1404 studies have been completed. Currently there are 481 trials underway, mostly located in Muskegon, Maryland."

Answered by AI

In what locations is this trial being conducted?

"This medical study is being operated at 18 different locations, some of which include Mercy Health Mercy Campus in Muskegon, Marie Yeager Cancer Center in Saint Joseph and Cancer and Hematology Centers of Western Michigan - Norton Shores. The other 15 clinical trial sites can be found on the official website."

Answered by AI

Could you expound upon the potential risks involved with Intravenous Immunoglobulin Therapy?

"The safety rating of Intravenous Immunoglobulin Therapy was estimated to be 2, as there is evidence that it is safe but no clinical studies yet supporting its efficacy."

Answered by AI

To what extent is the current experiment being populated by participants?

"Correct. Clinicaltrials.gov shows that this medical study, first posted on the 7th of January 2021, is still currently recruiting patients. An estimated 36 people must be recruited from 18 separate sites."

Answered by AI

Recent research and studies

Journal for ImmunoTherapy of CancerJournal

Success and Failure of Additional Immune Modulators in Steroid-refractory/resistant Pneumonitis Related to Immune Checkpoint Blockade

Beattie, Jason, Hira Rizvi, Paige Fuentes, Jia Luo, Adam Schoenfeld, I-Hsin Lin, Michael Postow, et al.. 2021. “Success and Failure of Additional Immune Modulators in Steroid-refractory/resistant Pneumonitis Related to Immune Checkpoint Blockade”. Journal for Immunotherapy of Cancer. BMJ. doi:10.1136/jitc-2020-001884.

clinicaltrials.govStudy

Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis

2021. "Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04438382.