HALO Cholangiocarcinoma/Gallbladder 101 is a clinical research study for patients with untreated, unresectable, locally advanced or metastatic cholangiocarcinoma (intrahepatic and/or extrahepatic) and/or gallbladder cancer.
This study is being done to find out if the investigational drug PEGPH20 (pegvorhyaluronidase alfa) combined with an approved standard of care chemotherapy (cisplatin + gemcitabine) and an immunotherapy (atezolizumab) enhances the ability of these combinations to treat these types of tumors. It is also being done to find out if there is a difference in the effects of these combinations on tumors that are high in a chain of sugars called hyaluronan (HA).*
* Patients' tumors will be tested for HA after entering the study.
Patients who qualify and enroll in this study will be assigned at random to receive one of the following study medications. All patients will receive standard of care chemotherapy (cisplatin + gemcitabine), regardless of study group. (Standard of care means it is recommended by experts.)
HA, which stands for hyaluronan (also called hyaluronic acid), is a chain of sugars that the body naturally makes. It associates with water molecules to form a gel-like substance. HA is common throughout the body and plays an important role in the normal function of many tissues, including the skin, joints, and eyes. It can also accumulate or build up in many solid tumors.
HA-HIGH describes a tumor that has a high level of HA, which is associated with an increase in pressure inside the tumor. The increase in pressure is believed to squeeze the blood vessels, causing the blood vessels to compress. This may make it harder for anti-cancer therapies and immune cells to reach and kill cancer cells, because they travel through the blood vessels.
PEGPH20 is an investigational drug, which means it is currently not FDA approved for the treatment of cholangiocarcinoma or gallbladder cancer. It is a special type of protein, called an enzyme, that breaks down HA. Halozyme believes PEGPH20 may enhance the ability of certain anti-cancer therapies and immune cells to kill cancer cells of HA-HIGH tumors by breaking down HA inside these tumors.
PEGPH20 is being studied to find out if breaking down HA in HA-HIGH tumors may help anti-cancer therapies and immune cells work better.Find out if you may be eligible for this study >
† Final eligibility will be determined during the study screening process.
|AZ||Scottsdale||Mayo Clinic Arizona|
|CA||Duarte||City of Hope|
|CA||La Jolla||Scripps Memorial Hospital|
|CA||Los Angeles||UCLA - David Geffen School of Medicine|
|CA||Los Angeles||University of Southern California|
|CA||Whittier||The Oncology Institute of Hope and Innovation|
|CT||New Haven||Yale Cancer Center|
|DC||Washington||Lombardi Cancer Center, Georgetown University|
|MA||Boston||Beth Israel Deaconess Medical Center|
|MD||Baltimore||Johns Hopkins University|
|MI||Ann Arbor||University of Michigan Cancer Center|
|MO||St. Louis||Washington University School of Medicine|
|NC||Durham||Duke Cancer Institute|
|NV||Las Vegas||Comprehensive Cancer Centers of Nevada|
|NY||New York||Mount Sinai|
|NY||Rochester||University of Rochester Medical Center|
|OH||Canton||Gabrail Cancer Center|
|PA||Pittsburgh||University of Pittsburgh Medical Center|
|SC||Charleston||Medical University of South Carolina|
|TX||Houston||MD Anderson Cancer Center|
|WA||Seattle||Seattle Cancer Care Alliance|
|WI||Milwaukee||Froedtert Hospital and Medical College|