A Clinical Study for Untreated, Unresectable, Locally Advanced or Metastatic Cholangiocarcinoma and/or Gallbladder Cancer

WHAT IS HALO CHOLANGIOCARCINOMA/
GALLBLADDER 101?

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.

WHY IS THIS STUDY BEING DONE?

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.

WHAT STUDY MEDICATIONS DO ENROLLED PATIENTS RECEIVE?

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.)

  • PEGPH20 + cisplatin + gemcitabine + atezolizumab (given to 2 out of 5 patients)
  • PEGPH20 + cisplatin + gemcitabine (given to 2 out of 5 patients)
  • Cisplatin + gemcitabine (given to 1 out of 5 patients)

WHAT ARE SOME IMPORTANT THINGS TO KNOW ABOUT THE STUDY MEDICATIONS?

  • PEGPH20 is an investigational drug, which means it has not been FDA-approved for cholangiocarcinoma or gallbladder cancer. Over 200 patients have received PEGPH20 in studies for other types of cancer.
  • Atezolizumab (brand name TECENTRIQ®) is an immunotherapy drug that works by helping the immune system fight cancer. It is approved by the FDA for certain types of cancer. It is not FDA-approved for cholangiocarcinoma or gallbladder cancer.
  • Cisplatin + gemcitabine is standard of care chemotherapy for untreated, unresectable, locally advanced, or metastatic cholangiocarcinoma and/or gallbladder cancer. This is given to all study enrollees.

Learn about HA and HA-HIGH cancer >

WHAT IS HYALURONAN (HA)?

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.

WHAT IS HA-HIGH CANCER?

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.

Learn about the investigational drug PEGPH20 >

WHAT IS PEGPH20?

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.

WHY IS PEGPH20 BEING STUDIED?

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 >

ARE YOU ELIGIBLE?

Patients may qualify to take part in HALO Cholangiocarcinoma/Gallbladder 101 if they:

  • Are 18 years old and over
  • Have confirmed untreated, unresectable, locally advanced, or metastatic cholangiocarcinoma (intrahepatic and/or extrahepatic) and/or gallbladder cancer
  • Meet other entry requirements

Final eligibility will be determined during the study screening process.

FIND A STUDY SITE

If you would like to contact one of these sites to learn more about HALO Cholangiocarcinoma/Gallbladder 101, or if you do not see a site near you, please call 510-338-6061.

State City Study Site
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 Sacramento UC Davis
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
WA Seattle Virginia Mason
WI Milwaukee Froedtert Hospital and Medical College