Second-line Study of PEGPH20 and Pembro for HA High Metastatic PDAC
Status:
Unknown status
Trial end date:
2021-01-01
Target enrollment:
Participant gender:
Summary
This study is the study of the combination of PEGPH20 and Pembrolizumab (MK-3475) for
patients with previously treated Hyaluronan High (HA-high) metastatic pancreatic ductal
adenocarcinoma. This study is an interventional, unblinded, open label study. Approximately
35 subjects will be enrolled. The trial will require approximately a total of 18 months,
including 12 months for enrollment, with an additional 6 months for patient follow-up, data
collection and study closure.
Each subject will participate in the trial from the time the subject signs the Informed
Consent Form (ICF) through the final contact. After a screening phase of up to 21 days,
eligible subjects will receive PEGPH20 beginning with Cycle 1 Day 1, on Days 1, 8 15 of every
3 week-cycles and pembrolizumab beginning on Cycle 1 Day 1 (2-4 hrs after PEGPH20), every
3-week-cycles.
Treatment with PEGPH20 and pembrolizumab will continue until progressive disease (PD),
unacceptable adverse events (AEs), intercurrent illness that prevents further administration
of treatment, investigator's decision to withdraw the subject, subject withdraws consent,
pregnancy of the subject, noncompliance with trial treatment or procedure requirements,
subject receives 35 treatments (approximately 24 months) of pembrolizumab, or administrative
reasons requiring cessation of treatment. Subjects who discontinue for reasons other than PD
will have post-treatment follow-up for disease status until PD, initiating a non-study cancer
treatment, withdrawing consent, or becoming lost to follow-up. All subjects will be followed
by telephone for overall survival (OS) until death, withdrawal of consent, or the end of the
study.
After the end of treatment, each subject will be followed for 30 days for AE monitoring.
Serious adverse events (SAE) and events of clinical interest (ECI) will be collected for 90
days after the end of treatment or for 30 days after the end of treatment if the subject
initiates new anticancer therapy, whichever is earlier.
Phase:
Phase 2
Details
Lead Sponsor:
Pancreatic Cancer Research Team
Collaborators:
Halozyme Therapeutics Merck Sharp & Dohme Corp. University of Washington