Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

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).

Official Title

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

Details

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.

Keywords

NSCLCGastric CancerStomach NeoplasmsPembrolizumabPEGPEMPEGPEM (PEGPH20 + pembrolizumab)

Eligibility

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.

Locations

  • University of California San Diego - Moores Cancer Center
    La JollaCalifornia92093United States
  • St. Joseph's Hospital
    OrangeCalifornia92868United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Halozyme Therapeutics
ID
NCT02563548
Phase
Phase 1
Study Type
Interventional
Last Updated