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

Stopped early · Phase 1

Conditions studied: Cholangiocarcinoma Non-resectable, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic, Gallbladder Adenocarcinoma

In brief

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).

Key facts

Study ID

NCT03267940

Run by

Halozyme Therapeutics

People needed

85

Starts

2017-10-02

Expected to finish

2019-11-11

Last updated by the study team

2020-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For both portions of the study, participants must satisfy all of the following inclusion criteria to be enrolled in the study:
• Written Institutional Review Board/Ethics Committee-approved informed consent form (ICF), signed by participant or legally authorized representative.
• Participants must be determined to have histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of the intra- and/or extra-hepatic bile ducts and/or gallbladder. Participants must have sufficient tissue with architectural integrity, including tumor and associated stroma, available for retrospective biomarker testing.
• One or more lesions measurable on computed tomography (CT) scan/magnetic resonance imaging (MRI) scan per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1).
• Participants having Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• Life expectancy ≥3 months.
• Males and females aged ≥18 years.
• Screening clinical laboratory values within pre-determined parameters
• Female participants of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 7 days before Day 1 (first dose of study medication).
• For WOCBP and for men, agreement to use a highly effective contraceptive method from the time of screening throughout the study until 5 months (WOCBP) or 6 months (men) after administration of the last dose of any study medication. Highly effective contraceptive methods consist of prior sterilization, intrauterine device (IUD), intrauterine hormone releasing system (IUS), oral or injectable contraceptives, barrier methods, and/or true sexual abstinence.

You may not qualify if…

• Participants are ineligible for enrollment if they meet any of the following exclusion criteria:
• Clinical evidence of deep vein thrombosis or pulmonary embolism present during the screening period
• New York Heart Association Class III or IV cardiac disease, atrial fibrillation, unstable angina, or myocardial infarction within the past 12 months before screening.
• Participants with known brain metastases
• History of cerebrovascular accident or transient ischemic attack
• History of active bleeding within the last 3 months prior to screening requiring transfusion.
• Participants must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for treatment of metastatic or locally advanced disease.
• Intolerance to non-steroidal anti-inflammatory drugs (NSAIDs).
• Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening
• Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening
• History of:
• Idiopathic pulmonary fibrosis, organizing pneumonia (for example, bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Or known cases of hepatobiliary diseases (for example, primary biliary cholangitis, primary sclerosing cholangitis, history of immune-mediated cholangitis);
• Participants with cholangitis attributed to infectious etiology (for example, ascending cholangitis, bacterial cholangitis) are eligible if the infection has been fully resolved prior to the screening visit.
• Or known cases of drug-induced hepatobiliary toxicities.
• Active or history of autoimmune diseases
• Uncontrolled hypercalcemia

Where it is running

• 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 D.C., 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 — St 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

Full record on ClinicalTrials.gov

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