A Trial of PEGPH20 in Combination With Avelumab in Chemotherapy Resistant Pancreatic Cancer
NCT03481920 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2019-08-22
Summary
The purpose of this study is to evaluate the pharmacodynamics, safety and efficacy of PEGPH20 in combination with Avelumab in adult patients with chemotherapy resistant advanced or locally advanced pancreatic ductal adenocarcinoma (PDAC). This is a multi-center, open-label, non-randomized trial.
Conditions
Interventions
- DRUG
-
PEGylated Recombinant Human Hyaluronidase (PEGPH20)
PEGPH20 will be administered at a dose of 3.0 micrograms per kilogram (μg/kg) as an intravenous (IV) infusion.
- DRUG
-
Avelumab
Avelumab will be administered as at a dose of 10 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once every 2 weeks.
Sponsors & Collaborators
-
PH Research, S.L.
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-10
- Primary Completion
- 2019-01-10
- Completion
- 2019-06-10
Countries
- Spain
Study Locations
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