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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to Therapy

An international, multicenter, open-label, 2 cohort, non-comparative, pivotal study evaluating the efficacy of tipifarnib in HRAS mutant HNSCC (AIM-HN). The first cohort will assess the objective response rate (ORR) of tipifarnib in subjects with HNSCC with HRAS mutations. The second study cohort, SEQ-HN, is an observational sub-study and includes 2 types of patients: (1) the historical record of first line therapy in subjects with HRAS mutant HNSCC participating in Cohort 1 in whom first line outcome data are available and (2) matched control HNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.
Not Available
II
Gibson, Mike
NCT03719690
VICCHN18117

Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced / Metastatic Solid Tumors

This study is an open-label Phase 1 / Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced / metastatic solid tumors.
Not Available
I
Gibson, Mike
NCT02903914
VICCPHI1841

Multimodality Therapy before and after Surgery in Patients with Squamous Cell Carcinoma of the Head and Neck

This phase II clinical trial studies how well multimodality therapy works before and after surgery in patients with squamous cell carcinoma of the head and neck. Immunotherapy with monoclonal antibodies, such as durvalumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin, nab-paclitaxel, and cisplatin, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving carboplatin, nab-paclitaxel, and durvalumab before surgery and using durvalumab with or without radiation therapy and cisplatin after surgery may kill more tumor cells in patients with head and neck cancer.
Not Available
II
Gibson, Mike
NCT03174275
VICCHN1890

A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma

This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining CDX-3379 and cetuximab. The study will enroll patients with advanced head and neck squamous cell carcinoma who have previously received cetuximab and progressed.
Not Available
II
Gibson, Mike
NCT03254927
VICCHN1891

Study of BGB-290 or Placebo in Patients With Advanced or Inoperable Gastric Cancer

This study will enroll subjects with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A subjects will receive BGB-290; in Arm B subjects will receive placebo. The purpose of this study is to show that BGB-290 (versus placebo) will improve progression-free survival (PFS) in subjects with advanced or inoperable gastric cancer.
Not Available
III
Gibson, Mike
NCT03427814
VICCGI1892

Nivolumab and Ipilimumab in Treating Patients with Esophageal and Gastroesophageal Junction Adenocarcinoma Undergoing Surgery

This phase II / III trial studies the usefulness of treatment with nivolumab and ipilimumab in addition to standard of care chemotherapy and radiation therapy in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery. Immunotherapy with antibodies, such as nivolumab and ipilimumab, may remove the brake on the body’s immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy and radiation therapy may reduce the tumor size and the amount of normal tissue that needs to be removed during surgery. A combined treatment with nivolumab and ipilimumab, chemotherapy, and radiation therapy might be more effective in patients with esophageal and gastroesophageal junction adenocarcinoma who are undergoing surgery.
Not Available
II/III
Gibson, Mike
NCT03604991
ECOGGIEA2174

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