The Efficacy and Safety of Corticosteroids in Combination With Ruxolitinib in the Management of Checkpoint Inhibitor Pneumonia

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05899725
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 26.5
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Checkpoint Inhibitor Pneumonitis	Drug: Corticosteroids; Drug: Corticosteroids and Ruxolitinib	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Apr 14, 2023
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cohort 1: severe CIP with the treatment of corticosteroids severe CIP with the treatment of corticosteroids	Drug: Corticosteroids; Initial dosage of corticosteroids is more than predinisone 1mg/kg/d or other corticosteroids with equal equivalence
Experimental: Cohort 2: severe CIP with the treatment of corticosteroids and Ruxolitinib severe CIP with the treatment of corticosteroids and Ruxolitinib	Drug: Corticosteroids and Ruxolitinib; Initial dosage of corticosteroids is more than predinisone 1mg/kg/d or other corticosteroids with equal equivalence, add-on oral Ruxolitinib 5mg twice a day for 2 weeks, following with Ruxolitinib

Outcome Measures

Primary Outcome Measures

1. Proportion of patients with dosage of corticosteroids less than 10mg daily at improvement to CIP with CTCAE grade 1. [8 weeks]

   Proportion of patients with dosage of corticosteroids less than 10mg daily at improvement to CIP with CTCAE grade 1.

Secondary Outcome Measures

1. Mortality [8 weeks]

   Mortality of severe CIP patients at 8 weeks.

2. Proportion of invasive ventilator assisted respiration [8 weeks]

   Proportion of invasive ventilator assisted respiration treatment for severe CIP patients at 8 weeks.

3. Incidence of pulmonary infection [8 weeks]

   Incidence of pulmonary infection in severe CIP patients in 8 weeks.

4. Total corticosteroids usage [8 weeks.]

   Total corticosteroids usage for severe CIP patients in 8 weeks.

5. The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG [8 weeks.]

   The incidence of treatment with immunosuppressants and the incidence of treatment with IVIG for severe CIP patients in 8 weeks.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18 years old≤ Aged ≤75 years old.

2. Diagnosis of malignancy.

3. Malignant tumors initially treated with anti-PD-1 in combination with or without chemotherapy.

4. Diagnosis of grade 3 or 4 CIP: CIP severity at CTCAE grade 3 or 4.

5. 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:

1. Predicted life expectancy<12 weeks.

2. 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.

3. malignancy progression.

4. Patients with other serious complications that may affect safety or adherence judged by the investigator.

5. Any significant clinical and laboratory abnormalities judged by investigator that affect the safety evaluation.

6. Patients can't fully understand the study protocol, arrangement and other study-related elements.

7. Patients with evidence of severe liver or kidney dysfunction judged by investigator unsuitable for enrolment.

8. Women who are pregnant, breast feeding or unable to use effective contraception during the study period and for 3 months after the completion.

9. Patients who cannot comply with study treatment and follow-up according to the trial protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Respiratory Medicine, Peking Union Medical College Hospita	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wang mengzhao, Chief Director of Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT05899725
• Other Study ID Numbers: K22C2678
• First Posted: Jun 12, 2023
• Last Update Posted: Jun 13, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia

Study Results

No Results Posted as of Jun 13, 2023