Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Blood and Lymph Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Small Cell Lung Carcinoma

Thoracic Neoplasms

Thymoma

Thymus Neoplasms

Respiratory Tract Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neoplasms by Histologic Type

Lymphatic Diseases

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Vorolanib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Participants receive vorolanib PO QD on days 1-56 and nivolumab IV over 30 minutes every two weeks (i.e. on Days 1, 15, 29, and 43 of each 56-day cycle) for the first two treatment cycles. After which, the treatment schedule can change to every four weeks (i.e., on Days 1 and 29 of each 56-day cycle) if the patient is not exhibiting disease progression.

Kathryn Beckermann, MD

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.

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.

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

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

Antitumor activity will be assessed by objective response rate.

Antitumor activity will be assessed by progression free survival.

Antitumor activity will be assessed by duration of response.

Antitumor activity will be assessed by disease control rate.

Antitumor activity will be assessed by 1 year survival.

Antitumor activity will be assessed by correlation between the biomarkers and clinical outcomes.

Duration of Response (DOR) will also be assessed using Kaplan-Meier (KM) product-limit method. Median value of DOR, along with two-sided 95% CI using Brookmeyer and Crowley method will be reported.

Summarized by binomial response rate and their corresponding two-sided 95% exact CIs using Clopper-Pearson method.

Summarized by binomial response rate and their corresponding two-sided 95% exact CIs using the Clopper-Pearson method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors	NCT03583086	Thymic Carcinom... Non-small Cell ... Refractory Thor... Small-Cell Lung...	Vorolanib Nivolumab	18 Years -	Vanderbilt-Ingram Cancer Center
Phase I/II Eval Safety & Prelim Activity Nivolumab Comb W/Vorolanib Pts W/Refractory Thoracic Tumors	NCT03583086	Thymic Carcinom... Non-small Cell ... Refractory Thor... Small-Cell Lung...	Vorolanib Nivolumab	18 Years -	Vanderbilt-Ingram Cancer Center

Spots Global Cancer Trial Database for refractory thoracic tumors