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Coorticosteroid Regimen in Patients With Anti-PD-1/PD-L1 Induced Pneumonitis

NCT04036721 · Status: SUSPENDED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2023-02-23

No results posted yet for this study

Summary

This is a prospective interventional open-label randomized trial. The patients treated with anti-

PD-1 (programmed-death receptor type 1) or anti-PD-L1 (programmed-death ligand) antibodies in case of new acute onset interstitial changes or new seriuos respiratory system related symptoms will be recruited for this study to perform diagnostics. At the recruitment the patient will be randomized 1:1 to investigatory or control arm, the randomization will be stratified upon three criteria:

1. severity of suspected pneumonitis at baseline (grade 2 vs. grade 3-4)
2. response for oncological treatment (partial response (PR) and complete response (CR) vs. stable disease (SD) and progression disease (PD))
3. chronic respiratory system disorders Both groups will be treated in the same way in terms of diagnostic procedures. In case of interstitial lung diseases related to immune checkpoint inhibitor is confirmed with the severity of grade 2-4 in the modified CTCAE criteria the patient will get the treatment, accordingly to the randomization: ARM A - INVESTIGATORY GROUP the start dose will be 1-4 mg/kg of body weight of prednisone, depending on clinical condition and pneumonitis severity, the induction treatment will last for 5-7 days, in case of severe condition - no improvement after 48-72 h of initial treatment - introduction of immunosuppressive agent is recommended - cyclophosphamide, mofetil mycophenolate or infliximab. A continuation treatment with dose tapering is than recommended, starting from 60mg q 24h of prednisone for 2-4 weeks, and dropping the dose 10mg q 24 h not faster than over 14 days; the maintenance dose of prednisone 10mg q 24 h should be hold for 8 weeks and withdraw should last for 4 weeks. This arm will be treated with corticosteroid for at least 12-24 weeks.

ARM B - CONTROL GROUP the starting dose will be 1-4mg/kg of body weight of prednisone , depending on clinical condition and pneumonitis severity, the induction treatment will last 5-7 days; in case of severe condition - no improvement after 48-72 h of initial treatment - introduction of immunosuppressive agent is recommended: cyclophosphamide, mofetil mycophenolate or infliximab. A continuation treatment with dose tapering is than planned, starting from oral dose of 30-60mg q 24h of prednisone, and dose reduction of 10mg q 24 h each 1 week. This arm will be treated for 6-12 weeks.

During the treatment and after its termination the function of respiratory system, interstitial changes in radiologic examinations, anticancer response, survival time, pneumonitis relapse and glucocorticosteroid side effects will be monitored and evaluated. The observation will last up to 52 weeks.

Conditions

Interventions

DRUG

Prolonged glucocorticosteroid (prednisone) regimen

Prolongation of maintenance therapy with prednisone of patients with pneumonitis inducted by anyi-PD-1/anti-PD-L1 antibodies.

DRUG

Short glucocorticosteroid (prednisone) regimen

Prednison regimen based upon American Society of Clinical Oncology and European Society for Medical Oncology Clinical Practice Guidelines on pneumonitis treatment in patients receiving immunotherapy agents

Sponsors & Collaborators

  • National Institute for Tuberculosis and Lung Diseases, Poland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2024-02-01
Completion
2026-02-01

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04036721 on ClinicalTrials.gov