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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 | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT03267940•Halozyme Therapeutics

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•3. Or known cases of drug-induced hepatobiliary toxicities.
+2 more criteria

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:
+2 more criteria

Locations (36)

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

Key Dates

Start Date

October 2, 2017

Primary Completion Date

November 11, 2019

Completion Date

November 11, 2019

Last Updated

February 7, 2020

Enrollment

ACTUAL participants

Conditions

Cholangiocarcinoma Non-resectableCholangiocarcinoma, IntrahepaticCholangiocarcinoma, ExtrahepaticGallbladder Adenocarcinoma

Interventions

PEGPH20

DRUG

CIS

DRUG

GEM

DRUG

Atezolizumab

DRUG

Combined HAIC, Lenvatinib and Pucotenlimab As Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma

NCT06192797

Cholangiocarcinoma Non-resectable

View study

NOT_YET_RECRUITING

TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort

NCT07454486

Biliary Tract Cancer (BTC)Biliary Tract Cancer (CCA)+12 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Combined HAIC, Lenvatinib and Pucotenlimab As Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma

TRACE-BTC. Relation of Biomarkers and Patients Reported Quality of Life to Outcomes in Patients With Biliary Tract Cancer: a Real- World Cohort

DEB-TACE, Lenvatinib and Anti-PD(L)1 Antibody as Conversion Therapy for Intrahepatic Cholangiocarcinoma

RFA RCT for Pancreatic or Bile Duct Cancer

Surgery for Recurrent Intrahepatic Cholangiocarcinoma