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, Cancer (Oncology)
Philip Gold, MD
Swedish Cancer Institute
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
(206) 215-3086