Spots Global Cancer Trial Database for CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab
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Trial Identification
Brief Title: CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab
Official Title: A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Administered in Combination With Nivolumab in Subjects With Non-small Cell Lung Cancer and Subjects With Metastatic Melanoma
Study ID: NCT03123783
Study Description
Brief Summary: This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when administered in combination with nivolumab. The Phase 2 portion of the study will evaluate safety and efficacy of the combination.
Detailed Description: APX005M-002 is an open-label Phase 1-2 study and comprises a dose-escalation portion (Phase 1) followed by a Phase 2 tumor specific portion. Eligible subjects with non-small cell lung cancer or metastatic melanoma will receive intravenous APX005M in combination with nivolumab until disease progression, unacceptable toxicity or death, whichever occurs first. Study objectives include: * Determine the maximum tolerated dose and the recommended phase 2 dose of APX005M when given in combination with nivolumab * Evaluate safety of the APX005M and nivolumab combination * Evaluate the objective response rate, duration of response and median PFS by RECIST 1.1 in subjects with non-small cell lung cancer or metastatic melanoma receiving APX005M in combination with nivolumab * Determine the PK of APX005M
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
Yale University, New Haven, Connecticut, United States
Hem-Onc Associates of the Treasure Coast, Port Saint Lucie, Florida, United States
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC), Baltimore, Maryland, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
SUNY Upstate Medical Hospital, Syracuse, New York, United States
University Hospitals Seidman Cancer Center, Cleveland, Ohio, United States
Abramson Cancer Center of The University of Pennsylvania, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Fox Chase Center, Rockledge, Pennsylvania, United States
Tennessee Oncology, Nashville, Tennessee, United States
Hospital Quirón Dexeus, Barcelona, , Spain
H. Vall d'Hebron, Barcelona, , Spain
H. Clinic i Provincial, Barcelona, , Spain
H. Insular de Gran Canaria, Las Palmas De Gran Canaria, , Spain
H. Lucus Augusti, Lugo, , Spain
H. Doce de Octubre, Madrid, , Spain
H. HM Sanchinnarro, Madrid, , Spain
H. de Málaga, Málaga, , Spain
H. General de Valencia, Valencia De Alcántara, , Spain
H. La Fe, Valencia, , Spain
Contact Details
Name: Medical Director
Affiliation: Pyxis Oncology, Inc
Role: STUDY_DIRECTOR
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