Nivolumab and Vorolanib in Treating Patients with Non-Small Cell Lung Cancer and Refractory Thoracic Tumors

Active:	No
Cancer Type:	Lung Cancer Thymus Cancer Unknown Primary	NCT ID:	NCT03583086
Trial Phases:	Phase I Phase II	Protocol IDs:	VICC THO 1802 (primary) NCI-2018-01300
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Vanderbilt University/Ingram Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT03583086

Summary

This phase I/II trial studies the side effects and best dose of vorolanib when given in combination with nivolumab in treating patients with non-small cell lung cancer and thoracic tumors that aren't responding to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Vorolanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab and vorolanib may work better in treating patients with non-small cell lung cancer and thoracic tumors.

Objectives

PRIMARY OBJECTIVES:
I. To assess the safety and tolerability of nivolumab and vorolanib in combination in patients with non-small cell lung cancer (NSCLC) naive to checkpoint inhibitor therapy, NSCLC progressed on prior checkpoint inhibitor therapy considered primary refractory, NSCLC progressed on prior checkpoint inhibitor therapy considered acquired resistance, and thymic carcinoma. (Phase I)
II. To evaluate the efficacy as measured by response to the combination nivolumab and vorolanib in patients with refractory NSCLC naive to checkpoint inhibitor therapy, NSCLC progressed on prior checkpoint inhibitor therapy considered primary refractory, NSCLC progressed on prior checkpoint inhibitor therapy considered acquired resistance, small cell lung cancer, and thymic carcinoma as compared to historical controls. (Phase II)

SECONDARY OBJECTIVE:
I. To assess the effects of tumor PD-L1 status and tumor mutation burden (TMB) on the response to combinatorial treatment vorolanib and nivolumab. (Phase II)

EXPLORATORY OBJECTIVE:
I. To assess the effects of combinatorial treatment on specific pharmacodynamic and pharmacogenetic biomarkers.

OUTLINE: This is a phase I, dose-escalation study of vorolanib followed by a phase II study.

Patients receive vorolanib orally (PO) once daily (QD) on days 1-56 and nivolumab intravenously (IV) over 30 minutes every 2 weeks on days 1, 15, 29, and 43. Patients with no evidence of disease progression after cycle 2 receive nivolumab IV over 30 minutes on days 1 and 29. Cycles repeat every 56 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo optional biopsy at screening and blood sample collections, magnetic resonance imaging (MRI) and computed tomography (CT) scans throughout the study.

After completion of study treatment, patients are followed up at 28 days and 100 days.

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