Spots Global Cancer Trial Database for A Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab in Participants With Selected Hyaluronan High Solid Tumors
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Trial Identification
Brief Title: A Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab in Participants With Selected Hyaluronan High Solid Tumors
Official Title: A Phase 1B Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Pembrolizumab in Subjects With Selected Hyaluronan-High Solid Tumors
Study ID: NCT02563548
Study Description
Brief Summary: This is a Phase 1b study evaluating a combination of PEGPH20 and pembrolizumab in hyaluronan-high (HA-high) participants with relapsed/refractory non-small cell lung cancer (NSCLC) and HA-high participants with relapsed/refractory gastric adenocarcinoma (GAC).
Detailed Description: Study involves dose escalation phase (completed in Nov-2016) to assess the safety and tolerability of PEGPEM (PEGylated recombinant human hyaluronidase \[PEGPH20\] combined with pembrolizumab \[Keytruda®\]) and to find the recommended Phase 2 dose (RP2D) ; and an expansion phase to assess the efficacy, safety and tolerability of PEGPEM in stage III b/IV NSCLC and relapsed/refractory GAC participants. Plan was to include approximately 51 HA-high participants (30 NSCLC and 21 GAC participants) in the dose expansion phase on the obtained RP2D from dose escalation phase of the study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Mayo Clinic, Scottsdale, Arizona, Scottsdale, Arizona, United States
California Cancer Associates for Research and Excellence - Encinitas, Encinitas, California, United States
University of California San Diego - Moores Cancer Center, La Jolla, California, United States
St. Joseph's Hospital, Orange, California, United States
University of California - Davis, Sacramento, California, United States
St. Joseph's Hospital, Santa Rosa, California, United States
Innovative Clinical Research, Whittier, California, United States
University of Colorado Denver University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Holy Cross Hospitals, Fort Lauderdale, Florida, United States
University of Miami/Sylvester Cancer Center, Miami, Florida, United States
Cleveland Clinic Florida, Weston, Florida, United States
Emory University, Atlanta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Center, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
New Jersey Hematology Oncology Associates, Brick, New Jersey, United States
University of Rochester, Rochester, New York, United States
Gabrail Cancer Center, Canton, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Swedish Health Services, Seattle, Washington, United States
Contact Details
Name: VP, Clinical Development
Affiliation: Halozyme Therapeutics
Role: STUDY_DIRECTOR
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