Pembrolizumab And PEGPH20 In Treating Patients With Metastatic Pancreatic Cancer

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-08-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-03-11
First Submitted that Met QC Criteria 2019-08-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-03-13
First Posted (ACTUAL) 2019-08-16	Results First Posted N/A	Last Verified 2020-03

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment (pembrolizumab, PEGPH20) Patients receive pembrolizumab IV over 10 minutes on day 1 and pegylated recombinant human hyaluronidase PH20 SC on days 1, 8, and 15. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.	BIOLOGICAL: Pegylated Recombinant Human Hyaluronidase PH20 Given SC BIOLOGICAL: Pembrolizumab Given IV

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (pembrolizumab, PEGPH20)

Patients receive pembrolizumab IV over 10 minutes on day 1 and pegylated recombinant human hyaluronidase PH20 SC on days 1, 8, and 15. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.

BIOLOGICAL: Pegylated Recombinant Human Hyaluronidase PH20

Given SC

BIOLOGICAL: Pembrolizumab

Given IV

Primary Outcome Measures	Measure Description	Time Frame
Progression free survival (PFS)	Descriptive statistics including with 90% confidence interval will be computed.	Up to 1 year

Secondary Outcome Measures	Measure Description	Time Frame
Incidence of adverse events	Descriptive statistics including with 90% confidence interval will be computed.	Up to 30 days post treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma based on pathology report
Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
Have at least one measurable lesion and one lesion available for biopsy (not the primary pancreatic lesion) based on RECIST 1.1. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Have had prior treatment with first-line therapy for metastatic disease for at least 4 months, and have had a radiologic response or stable disease at the most recent imaging. Adjuvant therapy for resected disease will not count as first-line therapy. Therapies that are derivative of others (e.g. fluorouracil/leucovorin calcium/oxaliplatin [FOLFOX] vis-a-vis fuorouracil/irinotecan/leucovorin/oxaliplatin [FOLFIRINOX]) will be counted as a single line of treatment for the purpose of determining the number of prior therapies
Be willing to undergo a core biopsy or excisional biopsy of tumor from a metastatic site. Note that the biopsy itself will be done only after the patient has been found to meet all other inclusion/exclusion criteria and the patient is otherwise prepared to start therapy
Be willing to provide (and have available) archival tissue from a surgical or biopsy specimen obtained PRIOR to the most recent chemotherapy
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Demonstrate adequate organ function. Specimens must be collected within 10 days prior to the start of trial treatment
Female subjects of childbearing potential must have a negative urine or serum pregnancy test at screening (prior to biopsy) and again within 24 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Male and female subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of trial therapy through 120 days after the last dose of trial therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Acceptable methods of contraception are as follows:

Single method (1 of the following is acceptable): intrauterine device (IUD), vasectomy of a female subject's male partner, contraceptive rod implanted into the skin
Combination method (requires use of 2 of the following): diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive: oral contraceptive pill (estrogen/ progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous (SC) contraceptive injection

Has pancreatic tumor other than adenocarcinoma, including: acinar cell carcinoma, pancreaticoblastoma, malignant cystic neoplasms, endocrine neoplasms, squamous cell carcinoma, ampulla of Vater, periampullary, duodenal, or common bile duct malignancies
Has had more than one line of systemic chemotherapy for metastatic disease
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has had prior treatment with PEGPH20
Has received prior systemic anti-cancer therapy that includes investigational agents within 2 weeks prior to treatment
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
Had a solid organ or hematologic transplant
Has active autoimmune disease that has required systemic treatment in past 3 months (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Patients with autoimmune colitis (eg Crohn's disease) will be excluded. Any relevant diseases not listed here are to be discussed with the study supporters. Replacement hormone therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed
Has a diagnosed additional malignancy within 1 year prior to first dose of study treatment, with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected tumors of low invasive potential (e.g. in situ cervical and/or breast cancers)
Has a history of central nervous system (CNS) metastases and/or carcinomatous meningitis
Has a history of (non-infectious) pneumonitis that required oral or IV steroids or currently has pneumonitis
Has an active infection requiring systemic therapy
Chronic use of steroids for pain or emesis management
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment
Has received prior immunotherapy including anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or with an agent directed to another stimulatory or co-inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137), or has previously participated in Merck pembrolizumab or PEGPH20 clinical trials
Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies) (HIV testing is required during screening)
Has a history of the following liver diseases: hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive), hepatitis C (defined as detectable hepatitis C virus [HCV] ribonucleic acid [RNA]), primary biliary cholangitis, primary sclerosing cholangitis, history of immune mediated cholangitis. Of note, patients with a history of bacterial cholangitis are eligible if the infection has been fully resolved prior to the screening visit. An exception is made for hepatitis C patients who have undergone treatment and who have negative serologic testing for at least one year
Has received a live vaccine within 30 days prior to the first dose of trial drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist) are live attenuated vaccines and are not allowed
Has a known history of active TB (Bacillus tuberculosis)
Is unable to tolerate a contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) for staging/restaging purposes
Has not recovered (i.e., grade 1 or at baseline) from adverse events (AEs) due to chemotherapy (neuropathy and alopecia are excluded)
Has clinical evidence of a deep vein thrombosis (DVT), pulmonary embolism (PE), or other known thrombotic event present during the screening period. Of note - this does not apply to splanchnic vein (eg portal / superior mesenteric vein) thrombosis that, in the opinion of the primary investigator, are primarily associated with the anatomic location of the underlying disease
Requires Megace (medroxyprogesterone acetate)
In the estimation of the treating physician or primary investigator, have had a clinical deterioration of their ECOG performance within the month prior to enrollment
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Has unstable angina, new onset angina within the last 3 months, myocardial infarction within the last 6 months, and current congestive heart failure New York Heart Association class III or higher. Additionally, subjects with myocardial infarction or atrial fibrillation within the past 12 months are excluded
Has a history of a cerebrovascular accident or transient ischemic attack
Known clinically significant pre-existing carotid artery disease
Has a history of active bleeding requiring transfusion within a 3 month period prior to screening
Known allergy/intolerance to hyaluronidase or dexamethasone
Has severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients
Contraindication to heparin or non-steroidal anti-inflammatory drugs (NSAIDs)
Known cases of drug-induced hepatobiliary toxicities (other than a radiological finding of fatty liver)

Collaborators and Investigators

Publications

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Resources

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Caregivers

Clinical Trial Record