Phase 1b Open-Label Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) With Pembrolizumab



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:October 31, 2015
End Date:June 30, 2019

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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 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).

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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:

1. Pneumonitis that requires oral or IV steroids;

2. 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.

3. 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.
We found this trial at
26
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Baltimore, Maryland 21287
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Detroit, Michigan 48201
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
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New Orleans, Louisiana 70121
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Orange, California 92868
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1 Shields Ave
Sacramento, California 95616
(530) 752-1011
University of California-Davis As we begin our second century, UC Davis is poised to become...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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1165 Montgomery Drive
Santa Rosa, California 95403
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13400 East Shea Boulevard
Scottsdale, Arizona 85259
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Seattle, Washington 98104
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Whittier, California 90603
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