Phase 1 study of immune checkpoint inhibitor Nivolumab in combination with Bezafibrate in pretreated advanced non-small cell lung cancer

Phase 1

• Conditions: Advanced non-small cell lung cancer (Stage III/IV or postoperative recurrent)

• Registration Number: JPRN-UMIN000029854
• Lead Sponsor: Kyushu University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-07
• Study Completion: 2019-10-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with an infection requiring systemic treatment. 2. Patients with the history of hypersensitivity to Bezafibrate, Polysorbate 80 that is the component of Nivolumab, and other drugs. 3. Patients with clinically significant psychiatric disease or symptom that would interfere with participation in this study. 4. Patients treated with administration of steroid equivalent to more than 10 mg /day predonine, or an immune suppressor (oral or intravenous) within 14 days before enrollment. Patients who do not suffer from current autoimmune diseases and are treated with inhalation or topical administration of steroid or patients with steroid equivalent to more than 10 mg /day predonine as adrenal cortex hormone replacement are eligible. 5. Patients with current or suspicious autoimmune diseases. 6. Patients with symptomatic brain metastases. 7. Patients with carcinomatous meningitis. 8. Active double cancer 9. Patients with unstable angina or poorly controlled hypertension or diabetes mellitus. 10. Patients with positive for hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody. 11. Patients with distinct interstitial pneumonitis or pulmonary fibrosis based on chest CT. 12 Patients whose withdrawal of HMG-CoA inhibitors during this trial are not allowed. 13. Patients with history of previous immune checkpoint inhibitor treatment including Nivolumab. 14. Pregnant or lactating females. Females of child-bearing potential with the positive result of the urine pregnancy test that was carried out within 14 days before enrollment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with dose-limiting toxicity (DLT)

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with at least 1 adverse event Response rate (RR) Progression-free survival (PFS)