Clinical TrialsThe James Cancer Center Columbus, OH
open for enrollment
Phase 1b Open-Label Study of PEGPH20 With Pembrolizumab
A Phase 1b Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined with Pembrolizumab in Subjects with Selected Hyaluronan-High Solid Tumors
This is a phase 1b study evaluating a combination of PEGPH20 and pembrolizumab for subjects
with relapsed/refractory advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have
failed at least 1 platinum-based chemotherapy regimen and subjects with relapsed/refractory
locally advanced or metastatic gastric adenocarcinoma after failing at least 1 chemotherapy
This is a phase 1b study for subjects with relapsed/refractory advanced or metastatic NSCLC
who have failed at least 1 platinum-based chemotherapy regimen and subjects with
relapsed/refractory locally advanced or metastatic gastric adenocarcinoma after failing at
least 1 chemotherapy regimen. This study will consist of a Phase 1b dose escalation portion
to determine the maximum tolerated dose (MTD) of either 1.6, 2.2, 3.0, 4.0 ug/kg (or higher
doses if necessary) of PEGPH20 in combination with Pembrolizumab. Once the recommended phase
2 dose has been identified in the escalation portion, additional patients selected for
high-HA tumors will be enrolled in the dose expansion portion
Are you eligible?
Histologically confirmed and documented, previously treated stage IIIB or IV Non
Small Cell Lung Cancer (NSCLC) having failed at least 1 previous platinum containing
chemotherapy regimen or recurrent locally advanced or metastatic gastric
adenocarcinoma having failed at least 1 previous chemotherapy regimen. Subjects with
NSCLC who are known to be epidermal growth factor receptor (EGFR)-mutation positive
must have received an EGFR inhibitor and subjects known to be anaplastic lymphoma
kinase (ALK)-mutation positive must have received an ALK inhibitor.
Prior to enrollment, confirmation of the following must be obtained:
Dose escalation - For subjects in the dose escalation portion of the study, it is
preferred that there is available archived tumor tissue in a formalin-fixed
paraffin-embedded (FFPE) block or 5-10 unstained core biopsy slides that meet
specific tissue sample requirements, however it is not mandatory for enrollment in
this portion of the study.
Dose expansion - For subjects in the dose expansion portion of the study, it is
mandatory that available archived tumor tissue in FFPE block or minimum of 5-10
unstained core biopsy slides that meet specific tissue sample requirements are
One or more tumors measurable on CT scan/MRI scan per RECIST v 1.1. - Previously
irradiated tumors may be eligible if they have clearly progressed in size.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Life expectancy ≥3 months.
Previous treatment with pembrolizumab, nivolumab, or other programmed cell death-1
antibody (anti- PD-1) or PD-1 ligand 1 antibody (anti-PD-L1) agents.
New York Heart Association Class III or IV (Appendix D) cardiac disease or myocardial
infarction within the past 12 months before screening, or preexisting atrial
Prior history of cerebrovascular accident or transient ischemic attack.
Patients with known interstitial fibrosis or interstitial lung disease.
Previous history of pulmonary embolism or pulmonary embolism found on screening exam.
Active autoimmune disease requiring systemic treatment within the past 3 months or
documented history of clinically severe autoimmune disease, or syndrome that requires
systemic steroids or immunosuppressive agents.
History of another primary cancer within the last 3 years that required treatment,
with the exception of non-melanoma skin cancer, early-stage prostate cancer, or
curatively treated cervical carcinoma in situ.