Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab, 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

Status: Administratively Complete

Description

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).

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria: 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. Exclusion Criteria: 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: 1. Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., 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. 2. Or known cases of hepatobiliary diseases (e.g., primary biliary cholangitis, primary sclerosing cholangitis, history of immune-mediated cholangitis); Participants with cholangitis attributed to infectious etiology (e.g., ascending cholangitis, bacterial cholangitis) are eligible if the infection has been fully resolved prior to the screening visit. 3. Or known cases of drug-induced hepatobiliary toxicities. - Active or history of autoimmune diseases - Uncontrolled hypercalcemia

Locations & Contacts

Arizona

Tucson
Banner University Medical Center - Tucson
Status: Active
Name Not Available

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Lia Etheridge
Email: LEtheridge@mednet.ucla.edu
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Raluca Dana Agafitei
Phone: 323-865-0467
Email: agafitei@med.usc.edu

Connecticut

New Haven
Yale University
Status: Active
Contact: Kamil Sadowski
Phone: 203-785-6661
Email: kamil.sadowski@yale.edu

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Approved
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New York

New York
Icahn School of Medicine at Mount Sinai
Status: Active
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: In review
Name Not Available

South Carolina

Charleston
Medical University of South Carolina
Status: Temporarily closed to accrual
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Halozyme Therapeutics

Trial IDs

Primary ID Halo-110-101
Secondary IDs NCI-2017-01902
Clinicaltrials.gov ID NCT03267940