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Phase 1b Open-Label Study of PEGPH20 With Pembrolizumab

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Halozyme Therapeutics
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT02563548
First received: August 31, 2015
Last updated: May 16, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
NSCLC Gastric Cancer Drug: PEGPEM Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • Efficacy of PEGPH20 and pembrolizumab combination by Objective response rate (ORR) [ Time Frame: Expansion phase ]
    based on RECIST v1.1 (Response Evaluation Criteria in Solid Tumors v.1.1) in Hyaluronan-high (HA-high) subjects


Secondary Outcome Measures:
  • Duration of response (DOR) based on RECIST v1.1 and immune related response criteria (irRC) [ Time Frame: Expansion phase ]
    during the expansion phase

  • Disease control rate (DCR) based on RECIST v1.1 and irRC [ Time Frame: Expansion phase ]
    during the expansion phase

  • PFS based on RECIST v1.1 and irRC [ Time Frame: Expansion phase ]
    during expansion


Estimated Enrollment: 81
Study Start Date: October 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEGPEM
PEGPH20 + pembrolizumab
Drug: PEGPEM
PEGPH20 + pembrolizumab

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02563548

Contacts
Contact: Halozyme Call Center 877-784-6135

  Show 27 Study Locations
Sponsors and Collaborators
Halozyme Therapeutics
  More Information

Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT02563548     History of Changes
Other Study ID Numbers: HALO-107-101
Study First Received: August 31, 2015
Last Updated: May 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pembrolizumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 19, 2017