drugset / Trial / NCT03267940
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
RandomizedSequentialOpen-labelTreatment
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).
Timeline
- Start
- 2017-10-02
- Primary completion
- 2019-11-11
- Completion
- 2019-11-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Pegvorhyaluronidase Alfa | Protein / enzyme biologic | 3 ug/kg | Intravenous |
| Background | CIS | Unknown | 25 mg/m2 | Intravenous |
| Background | GEM | Unknown | 1000 mg/m2 | Intravenous |