J17159 - 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 Hyaluronan-High (HA-high) Subjects with Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Johns Hopkins Kimmel Cancer Center in Baltimore
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 cholangiocarcinoma or gallbladder cancer. 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).
Males and females aged 18 years or greater with life expectancy greater than 3 months; confirmed untreated, unresectable, locally advanced, or metastatic cholangiocarcinoma (intrahepatic and/or extrahepatic) and/or gallbladder cancer;a tumor biopsy sample must be available; if an archival biopsy sample that meets study requirements is not available, a fresh biopsy is required;one or more lesions measurable on CT scan or MRI;good physical condition,good blood counts and organ function;ability to self-administer enoxaparin injections; no history of stroke;no known brain metastases;no clinical evidence of deep vein thrombosis or pulmonary embolism; no contraindications to heparin;no clinically significant carotid artery disease or liver disease; no history of or acute autoimmune disease.
Patients who qualify and enroll in this study will be assigned at random to receive one of the following study medications: 1)PEGPH20 + cisplatin + gemcitabine + atezolizumab, 2)PEGPH20 + cisplatin + gemcitabine; 3)Cisplatin + gemcitabine.PEGPH20 is an investigational drug, which means it has not been FDA-approved for cholangiocarcinoma or gallbladder cancer. It is a special type of protein, called an enzyme, that breaks down HA. The PEGPH20 may enhance the ability of certain anti-cancer therapies and immune cells to kill cancer cells. Atezolizumab 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 and 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.Patients require to self-administer daily enoxaparin (blood thinner)injections while treated with PEGPH20.
03/05/2019 05:03 AM