Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Stomach Neoplasms

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

Nivolumab

Vorolanib

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

* Vorolanib is an oral drug which will be administered daily on an outpatient basis at the assigned dose level.
* Patients receiving nivolumab will get it on an outpatient basis as a 30-minute intravenous infusion at a dose of 480 mg on Day 1 of each 28-day cycle
* In light of immunotherapy approach, treatment beyond progression is allowed as long as patient has clinical stability. Patients can stay on the regimen unless excessive toxicity or clinical or radiographic disease progression per RECIST

* Vorolanib is an oral drug which will be administered daily on an outpatient basis at the assigned dose level
* Patients receiving pembrolizumab will get it on an outpatient basis as a 30-minute (-5/+10 minutes) intravenous infusion at a dose of 200 mg on Day 1 of each 21-day cycle
* In light of immunotherapy approach, treatment beyond progression is allowed as long as patient has clinical stability. Patients can stay on the regimen unless excessive toxicity or clinical or radiographic disease progression per RECIST

* Vorolanib is an oral drug which will be administered daily on an outpatient basis at 300 mg daily
* Patients receiving nivolumab will get it on an outpatient basis as a 30-minute intravenous infusion at a dose of 480 mg on Day 1 of each 28-day cycle
* In light of immunotherapy approach, treatment beyond progression is allowed as long as patient has clinical stability. Patients can stay on the regimen unless excessive toxicity or clinical or radiographic disease progression per RECIST

Patients should take vorolanib at approximately the same time every day with food.

Nusayba A Bagegni, M.D.

The investigators hypothesize that vorolanib in combination with checkpoint inhibitors (pembrolizumab for gastric/gastroesophageal (GE) junction cancers and nivolumab for hepatocellular carcinoma (HCC)) may improve immunotherapy efficacy by overcoming treatment resistance of checkpoint inhibitors in gastrointestinal (GI) cancers.

Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors

A Phase IB Trial of Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors

-The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed for both nivolumab and pembrolizumab until the MTD or highest dose level (level 2), which is defined as RP2D.

-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.

Xcovery Holdings, Inc.

Washington University School of Medicine

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Small Cell Lung Carcinoma

Thoracic Neoplasms

Thymoma

Thymus Neoplasms

Respiratory Tract Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lymphatic Diseases

Small Cell Lung Cancer

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
Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors	NCT03511222	Solid Tumor Hepatocellular ... Gastric Cancer Gastroesophagea...	Vorolanib Nivolumab Pembrolizumab	18 Years -	Washington University School of Medicine
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
Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors	NCT03511222	Solid Tumor Hepatocellular ... Gastric Cancer Gastroesophagea...	Vorolanib Nivolumab Pembrolizumab	18 Years -	Washington University School of Medicine
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 vorolanib

Every month we try and update this database with for vorolanib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vorolanib

Every month we try and update this database with for vorolanib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vorolanib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.