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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholangiocarcinoma Non-resectable
• Cholangiocarcinoma, Intrahepatic
• Cholangiocarcinoma, Extrahepatic
• Gallbladder Adenocarcinoma

Interventions

Type	Name	Description
DRUG	PEGPH20	PEGPH20 will be administered as per the schedule specified in the respective arms.
DRUG	CIS	CIS will be administered as per the schedule specified in the respective arms.
DRUG	GEM	GEM will be administered as per the schedule specified in the respective arms.
DRUG	Atezolizumab	Atezolizumab will be administered as per the schedule specified in the respective arms.

Timeline

• Start date: 2017-10-02
• Primary completion: 2019-11-11
• Completion: 2019-11-11
• First posted: 2017-08-31
• Last updated: 2020-02-07
• Results posted: 2020-02-07

Locations

36 sites across 3 countries: United States, South Korea, Thailand

Regulatory

• FDA-regulated drug study