Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors

Non-small Cell Lung Cancer Clinical Trial

Official title: Phase 1/2 Study to Evaluate the Safety and Preliminary Activity of Nivolumab in Combination With Vorolanib in Patients With Refractory Thoracic Tumors

Status Active, not recruiting

Clinical Trial Summary

This is a two-agent, open-label, non-randomized, Phase 1/2 dose escalation and dose expansion study of combinatorial oral vorolanib plus infusional nivolumab in patients with Non-Small Cell Lung Cancer naïve to checkpoint inhibitor therapy, Non-Small Cell Lung Cancer who have progressed on checkpoint inhibitor therapy, Small Cell Lung Cancer ( who have progressed on platinum-based chemotherapy, and thymic carcinoma.

Clinical Trial Description

Primary Objectives:

• Phase I: To assess the safety and tolerability of nivolumab and vorolanib in combination in patients with refractory non small cell lung cancer naïve to checkpoint inhibitor therapy, non small cell lung cancer progressed on prior checkpoint inhibitor therapy considered primary refractory, non small cell lung cancer progressed on prior checkpoint inhibitor therapy considered acquired resistance, small cell lung cancer progressed on platinum-based chemotherapy, and thymic carcinoma.

• Phase II: To evaluate the efficacy as measured by response to the combination nivolumab and vorolanib in patients with refractory non small cell lung cancer naïve to checkpoint inhibitor therapy, non small cell lung cancer progressed on prior checkpoint inhibitor therapy considered primary refractory, non small cell lung cancer progressed on prior checkpoint inhibitor therapy considered acquired resistance, small cell lung cancer progressed on platinum-based chemotherapy, and thymic carcinoma as compared to historical controls.

Secondary Objectives:

• Phase I: To assess antitumor activity as measured by response rate for this novel combination.

• Phase II: To assess, safety, progression free survival and overall survival

Exploratory Objectives:

• To assess the effects of combinatorial treatment on specific pharmacodynamic and pharmacogenetic biomarkers including PD-L1 expression and tumor mutation burden. ;

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer
• Refractory Thoracic Tumors
• Small Cell Lung Carcinoma
• Small-Cell Lung Cancer
• Thoracic Neoplasms
• Thymic Carcinoma
• Thymoma

• NCT number: NCT03583086
• Study type: Interventional
• Source: Vanderbilt-Ingram Cancer Center
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 10, 2018
• Completion date: July 2025