Spots Global Cancer Trial Database for Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
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Trial Identification
Brief Title: Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Official Title: A Phase 1B, Randomized, Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With Cisplatin Plus Gemcitabine and PEGPH20 in Combination With Atezolizumab and Cisplatin Plus Gemcitabine Compared With Cisplatin Plus Gemcitabine in Subjects With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Study ID: NCT03267940
Study Description
Brief Summary: The study is being conducted to assess the safety and tolerability of (1) PEGPH20 in combination with CIS and GEM (PEGCISGEM), and (2) PEGPH20 in combination with CIS, GEM, and atezolizumab (PEGCISGEMATEZO) compared with (3) cisplatin and gemcitabine (CISGEM).
Detailed Description: The study will have a Run-in portion and an Expansion portion. The Run-in portion will be used to evaluate the safety profile of the PEGCISGEM and PEGCISGEMATEZO treatments prior to evaluating the efficacy and safety of PEGCISGEM and PEGCISGEMATEZO treatments compared with CISGEM treatment in the Expansion portion of the study. Treatment in both portions of the study will continue until death, withdrawal of consent from the study, disease progression, or unacceptable toxicity.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic of Arizona, Phoenix, Arizona, United States
University of Arizona, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
Scripps, La Jolla, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California Irvine Division of Hematology-Oncology, Department of Medicine UC Irvine Health, Orange, California, United States
UC Davis, Sacramento, California, United States
UCLA - David Geffen School of Medicine, Santa Monica, California, United States
The Oncology Institute of Hope and Innovation, Whittier, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Lombardi Cancer Center, Georgetown University, Washington, District of Columbia, United States
Johns Hopkins, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mount Sinai, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
MD Anderson Cancer Center, Houston, Texas, United States
UT Health Cancer Center, San Antonio, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Virginia Mason, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Froedtert Hospital And Medical College, Milwaukee, Wisconsin, United States
Samsung Medical Center, Seoul, Gangnam-gu, Korea, Republic of
Korea University Guro Hospital, Seoul, Guro-gu, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital, Seoul, Jongno-gu, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Seocho-gu, Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seodaemun-Gu, Korea, Republic of
Asan Medical Center, Seoul, Songpa-gu, Korea, Republic of
Maharaj Nakorn Chiang Mai Hospital, Chiang mai, Muang, Thailand
King Chulalongkorn Memorial Hospital, Bangkok, Patumwan, Thailand
Prince of Songkla University, Hat Yai, Songkla, Thailand
Contact Details
Name: VP, Medical, Regulatory and Drug Safety
Affiliation: Halozyme Therapeutics
Role: STUDY_DIRECTOR
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