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 regimen.
Cancer (Oncology) - All Solid Tumors,
Philip Gold, MD
Swedish Cancer Institute
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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:
- 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.