Spots Global Cancer Trial Database for APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers
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Trial Identification
Brief Title: APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers
Official Title: A Phase 2 Study of APX005M in Combination With Concurrent Chemoradiation as Neoadjuvant Therapy for Resectable Esophageal and Gastroesophageal Junction Cancers
Study ID: NCT03165994
Study Description
Brief 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.
Detailed Description: Primary Objective: To assess the efficacy of this novel combination, as measured by the pathologic complete response (pCR) rate. Secondary Objectives: 1. To further characterize the safety and feasibility of combining APX005M with SOC chemoradiation (external beam radiation in daily fractions, with concurrent weekly low-dose carboplatin/paclitaxel) in the neoadjuvant setting for patients with resectable esophageal and GE junction cancers. 2. To assess the efficacy of combining APX005M with SOC chemoradiation as measured by rates of R0 resection (microscopically negative margins, i.e., no tumor remains following surgery); and radiographic/metabolic response to neoadjuvant treatment on CT-PET. Exploratory Objectives: 1. To identify possible predictive molecular or immune-based efficacy biomarkers for this novel combination. 2. To characterize and assess overall survival.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona, Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of California, San Francisco, San Francisco, California, United States
MedStar Georgetown University Hospital (MGUH), Washington, District of Columbia, United States
New York University, New York, New York, United States
The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Wake Forest School of Medicine, Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Renovatio Clinical, The Woodlands, Texas, United States
University of Washington, Seattle, Washington, United States
Contact Details
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