NCT02846792

Nivolumab and Plinabulin in Treating Patients With Stage IIIB-IV, Recurrent, or Metastatic Non-small Cell Lung Cancer

A Phase I/II Clinical Trial of Nivolumab and Plinabulin for Patients With Advanced Stage Non-small Cell Lung Cancer That Have Progressed Through First Line Platinum Doublet Chemotherapy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of plinabulin when given together with nivolumab and to see how well they work in treating patients with stage IIIB-IV non-small cell lung cancer that has come back or spread to other places in the body. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as plinabulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab and plinabulin together may work better at treating patients with non-small cell lung cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of the combination of nivolumab and plinabulin. (Phase I) II. To determine the overall response rate (ORR) of treatment with nivolumab with the addition of plinabulin in the treatment of advanced stage non-small cell lung cancer in the second line setting. (Phase II) SECONDARY OBJECTIVES: I. To determine the progression free survival (PFS), disease control rate (DCR), duration of response (DOR) and overall survival (OS) of patients treated with nivolumab in combination with plinabulin. II. To determine the safety and tolerability of the combination of plinabulin and nivolumab. TERTIARY OBJECTIVES: I. Patients who have a pre-treatment and/or post cycle one biopsy will have flow cytometry of their tissue to identify infiltration of immune cells, rates of expression of programmed cell death 1 (PD-1), programmed cell death 2 (PD-2) and programmed cell death 1 ligand 1 (PDL1). OUTLINE: This is a phase I, dose-escalation study of plinabulin followed by a phase II study. Patients receive plinabulin intravenously (IV) over 30 minutes and nivolumab IV over 60 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 28 days.

Conditions

• ALK Gene Translocation
• EGFR Activating Mutation
• Recurrent Non-Small Cell Lung Carcinoma
• ROS1 Gene Translocation
• Stage IIIB Non-Small Cell Lung Cancer AJCC v7
• Stage IV Non-Small Cell Lung Cancer AJCC v7

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Given IV
DRUG	Plinabulin	Given IV

Timeline

• Start date: 2017-06-14
• Primary completion: 2018-07-12
• Completion: 2018-08-16
• First posted: 2016-07-27
• Last updated: 2019-03-04
• Results posted: 2019-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study