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) subjects with relapsed/refractory Non-Small Cell Lung Cancer (NSCLC) and HA-high subjects with relapsed/refractory gastric adenocarcinoma.

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

Study involves dose escalation phase (completed in Nov-2016) to find the RP2D dose and an expansion phase to assess the safety and tolerability of the RP2D dose within stage III b/IV NSCLC and relapsed/refractory gastric adenocarcinoma subjects.

Plan is to include approximately 51 HA-high subjects (30 NSCLC and 21 GAC subjects) in the dose expansion phase on the obtained RP2D from dose escalation phase of the study.

Keywords

NSCLC Gastric Cancer Stomach Neoplasms Pembrolizumab PEGPEM

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 Non-Small Cell Lung Cancer (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. 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 expansion - For subjects in the dose expansion portion of the study, it is mandatory that available archived tumor tissue in FFPE block or minimum 10 unstained consecutive core biopsy slides from 1 archival block that meet specific tissue 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.

Subjects must also satisfy the following inclusion criterion:

  • Subjects (NSCLC and gastric adenocarcinoma) must be determined to have HA-high levels from their tumor biopsies.
  • NSCLC and gastric adenocarcinoma subjects must have tissue available for HA-selection and PD-L1 testing.

You CAN'T join if...

  • Previous treatment with pembrolizumab, nivolumab, or other programmed cell death-1 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 subjects with known brain metastases (certain exceptions allowed)
  • Gastric adenocarcinoma subjects with brain metastases
  • History of active bleeding within the last 3 months requiring transfusion
  • Anti-angiogenic therapy within the last month
  • Patients 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);
  • Subjects 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 Jolla California 92093 United States
  • St. Joseph's Hospital
    Orange California 92868 United States
  • Innovative Clinical Research
    Whittier California 90603 United 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
June 4, 2018