The Efficacy and Safety of Corticosteroids in Combination With Biological Agents in the Management of Severe Immune Related Adverse Events Cohort A: The Efficacy and Safety of Corticosteroids or Corticosteroids Combination With Ruxolitinib in Patients With Severe Checkpoint Inhibitor Pneumonia

Peking Union Medical College Hospital1 site in 1 country60 target enrollmentApril 14, 2023

ConditionsSevere Checkpoint Inhibitor Pneumonitis

InterventionsCorticosteroids Corticosteroids and Ruxolitinib

DrugsCorticosteroids Corticosteroids and Ruxolitinib

Overview

Phase: Not Applicable
Intervention: Corticosteroids
Conditions: Severe Checkpoint Inhibitor Pneumonitis
Sponsor: Peking Union Medical College Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a prospective multicenter randomized controlled Interventional study, to assess the clinical efficacy and safety of corticosteroids compared to corticosteroids in combination with Ruxolitinib in the treatment of severe checkpoint inhibitor pneumonitis.

Registry

clinicaltrials.gov

Start Date

April 14, 2023

End Date

June 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Principal Investigator

Wang mengzhao

Chief Director of Department of Respiratory and Critical Care Medicine

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

•18 years old≤ Aged ≤80 years old.
•Diagnosis of malignancy.
•Malignant tumors initially treated with immune checkpoint inhibitors (antibodies targeting PD-1, PD-L1, CTLA-4, or new immune checkpoint inhibitors) in combination with or without chemotherapy.
•Diagnosis of grade 3 or 4 CIP: CIP severity at CTCAE grade 3 or
•Patients who and whose family members understand the study protocol, are willing to participate in the study and could provide written informed consent.

Exclusion Criteria

•Predicted life expectancy\<12 weeks.
•Any evidence of active or uncontrolled viral infection, including hepatitis B, hepatitis C and human immunodeficiency virus (HIV), or any clinical signs of bacterial, other viral, parasitic or fungal infection requiring treatment.
•malignancy progression.
•Patients with other serious complications that may affect safety or adherence judged by the investigator.
•Any significant clinical and laboratory abnormalities judged by investigator that affect the safety evaluation.
•Patients can't fully understand the study protocol, arrangement and other study-related elements.
•Patients with evidence of severe liver or kidney dysfunction judged by investigator unsuitable for enrolment.
•Women who are pregnant, breast feeding or unable to use effective contraception during the study period and for 3 months after the completion.
•Patients who cannot comply with study treatment and follow-up according to the trial protocol.

Arms & Interventions

Cohort 1: severe CIP with the treatment of corticosteroids

severe CIP with the treatment of corticosteroids

Intervention: Corticosteroids

Cohort 2: severe CIP with the treatment of corticosteroids and Ruxolitinib

severe CIP with the treatment of corticosteroids and Ruxolitinib

Intervention: Corticosteroids and Ruxolitinib

Outcomes

Primary Outcomes

Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.

Time Frame: 8 weeks

Proportion of patients with dosage of corticosteroids no more than 10mg daily at improvement to CIP with CTCAE grade 1.

Secondary Outcomes

Mortality(8 weeks)
Proportion of invasive ventilator assisted respiration(8 weeks)
Incidence of pulmonary infection(8 weeks)
Total corticosteroids usage(8 weeks.)
The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG(8 weeks.)