At a glance
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A Phase 2 Study of APX005M in Combination With Concurrent Chemoradiation as Neoadjuvant Therapy for Resectable Esophageal and Gastroesophageal Junction Cancers
In Brief
A Phase 2 clinical trial evaluating APX005M, Radiation Therapy, and 3 other interventions for Esophageal Cancer and GastroEsophageal Cancer. Completed, enrolled 34 participants across 10 sites.
Detailed Summary
This pilot phase II trial studies the therapeutic effects and side effects of CD40 agonistic monoclonal antibody APX005M when combined with chemotherapy and radiation therapy, and to see how well they work to reduce or remove esophageal or gastroesophageal (GE) cancers when given before surgery in treating patients with esophageal cancer or GE cancer than can be removed by surgery. APX005M is intended to stimulate the body's own immune system so that the immune cells can more effectively invade and destroy the tumor, adding to the benefits of the chemotherapy and radiation therapy. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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 APX005M, chemotherapy, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Study Details
Timeline
Interventions
APX005M IV infusion
Radiation therapy, total dose 5040cGy in 180cGy fractions
Paclitaxel IV infusion
Carboplatin IV infusion
Surgical removal of the tumor will occur between weeks 10-17