Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Phase 1b Open-Label Study of PEGPH20 With Pembrolizumab

Protocol: OSU-15219

Full Title

A Phase 1b Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined with Pembrolizumab in Subjects with Selected Hyaluronan-High Solid Tumors

Purpose

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

regimen.

Study Objective

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?

Inclusion Criteria:

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

available.

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.

Exclusion Criteria:

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

fibrillation.

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.

Stomach (Gastric) Cancer Gastrointestinal Cancers