Phase 1b Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab
This is a Phase 1b study evaluating a combination of PEGPH20 and pembrolizumab in hyaluronan-high (HA-high) participants with relapsed/refractory non-small cell lung cancer (NSCLC) and HA-high participants with relapsed/refractory gastric adenocarcinoma (GAC).
A Phase 1b Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) Combined With Pembrolizumab in Subjects With Selected Hyaluronan High Solid Tumors
This study includes a dose-escalation phase (completed in Nov-2016) to assess the safety and tolerability of PEGPEM combined with pembrolizumab (Keytruda®) and find the recommended Phase 2 dose (RP2D). The study also includes a dose-expansion phase to assess the efficacy, safety, and tolerability of PEGPEM in stage III b/IV NSCLC and relapsed/refractory GAC participants. The study will include approximately 51 HA-high participants (30 NSCLC and 21 GAC participants) in the dose-expansion phase on the obtained RP2D from the dose-escalation phase of the study.
NSCLCGastric CancerStomach NeoplasmsPembrolizumabPEGPEMPEGPEM (PEGPH20 + pembrolizumab)
You can join if…
Open to people ages 18 years and up
- Dose Expansion: Histologically confirmed and documented, previously untreated or treated stage IIIB or IV NSCLC having failed no more than 1 previous platinum containing chemotherapy regimen for locally-advanced or metastatic disease or relapsed/refractory locally advanced or metastatic gastric adenocarcinoma having failed no more than 2 previous chemotherapy regimen for locally advanced or metastatic disease. Participants with NSCLC who are known to be epidermal growth factor receptor (EGFR)-mutation positive must have received an EGFR inhibitor and participants 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:
• For participants in the dose expansion portion of the study, it is mandatory that available archived tumor tissue in formalin-fixed.
paraffin-embedded (FFPE) block or minimum 10-15 unstained consecutive core biopsy slides from 1 archival block that meet specific tissue requirements are available.
- For dose expansion: one or more tumors measurable on computed tomography (CT) scan/magnetic resonance imaging (MRI) scan per RECIST v 1.1., for dose escalation, participants need only have evaluable disease - 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 greater than or equal to (≥) 3 months.
Participants must also satisfy the following inclusion criterion to be enrolled in the dose expansion portion:
- Participants (NSCLC and gastric adenocarcinoma) must be determined to have HA-high levels from their tumor biopsies.
- NSCLC and gastric adenocarcinoma participants must have tissue available for HA-selection and programmed cell death-1 (PD-L1) testing.
You CAN'T join if...
- Previous treatment with pembrolizumab, nivolumab, or other antibody (anti-)-PD-1 or PD-1 ligand-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.
- NSCLC participants with known brain metastases (certain exceptions allowed)
- Gastric adenocarcinoma participants with brain metastases
- History of active bleeding within the last 3 months requiring transfusion
- Anti-angiogenic therapy within the last month
- Participants with known interstitial fibrosis or interstitial lung disease.
- Previous history of pulmonary embolism or pulmonary embolism found on screening exam.
- History of:
- Pneumonitis that requires oral or IV steroids;
- Or known cases of hepatobiliary diseases (e.g., primary biliary cholangitis, primary sclerosing cholangitis, history of immune-mediated cholangitis);
- Participants with cholangitis attributed to infectious etiology (e.g., ascending cholangitis, bacterial cholangitis) are eligible if the infection has been fully resolved prior to the screening visit.
- Or known cases of drug-induced hepatobiliary toxicities.
- 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.
- University of California San Diego - Moores Cancer Center
La JollaCalifornia92093United States
- St. Joseph's Hospital
- in progress, not accepting new patients
- Start Date
- Completion Date
- Halozyme Therapeutics
- Phase 1
- Study Type
- Last Updated