Clinical trial NCT03481920 (early phase 1, status: terminated)
Conditions: pancreatic ductal adenocarcinoma, pancreatic cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C25.3
Drugs: pegylated recombinant human hyaluronidase (pegph20), avelumab
SMILES: CCCCN1CCCCC1C(=O)NC1=C(C)C=CC=C1C, NC1=NC(=O)N(C=N1)[C@H]1C[C@H](O)[C@@H](CO)O1
Reason stopped: 
    stopped enrollment
  
Eligibility criteria:

        Key Inclusion Criteria:

          -  Signed, written IRB/IEC-approved Informed Consent Form

          -  Histologically or cytologically-confirmed pancreatic ductal adenocarcinoma (PDAC).

          -  Accessible tumor for two repeated tumor biopsies.

          -  Progression to first line treatment for locally advanced or advanced disease. Prior
             adjuvant chemotherapy or chemoradiation therapy for early disease is allowed.

          -  Age ≥18 years.

          -  Radiologically measurable disease per RECIST v1.1.

          -  Performance-status ECOG 0 -2.

          -  Life expectancy ≥ 3 months.

          -  Resolved acute effects of any prior therapy to baseline or Grade ≤1 severity

          -  Screening laboratory:

               1. Hematologic: ANC ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9
                  g/dL

               2. Hepatic: Total bilirubin level ≤ 1.5 × the ULN range and AST and ALT levels ≤ 2.5
                  × ULN or AST and ALT levels ≤ 5 X ULN (for subjects with documented metastatic
                  disease to the liver)

               3. Renal: Estimated creatinine clearance ≥ 30 mL/min according to the
                  Cockcroft-Gault formula or serum creatinine ≤ 2.0 mg/dL.

               4. Albumin ≥2.5 g/dL.

               5. Coagulation: PT time and INR within normal limits (+/-15%). PTT within normal
                  limits (+/-15%).

          -  If a subject requires anticoagulation, treatment must be modified to enoxaparin.

          -  Negative serum pregnancy test if female subject is of childbearing potential.

          -  Patients who are willing and able to comply with scheduled visits, treatment plans,
             laboratory tests, biopsies when required, and other procedures.

        Exclusion Criteria:

          -  Clinical evidence of DVT, PE, prior history of CVA or history of TIA within 12 months
             or other known TE event present during the screening period

          -  Current use of megestrol acetate (use within 10 days of Day 1).

          -  Contraindication to heparin as per institutional guidelines.

          -  Another primary cancer within the last 3 years currently requiring antineoplastic
             treatment within the exception of non-melanoma skin cancer, early-stage prostate
             cancer, or curatively treated cervical carcinoma in-situ.

          -  Current use of immunosuppressive medication within 2 weeks of study participation,
             EXCEPT for those listed in protocol

          -  Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory
             agent: Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid
             diseases not requiring immunosuppressive treatment are eligible.

          -  Prior organ transplantation including allogenic stem-cell transplantation.

          -  Active infection requiring systemic therapy.

          -  Known infection with human immunodeficiency virus, Hepatitis B, or Hepatitis C

          -  Known prior severe hypersensitivity to investigational product, hyaluronidase, or any
             component in its formulations, including known severe hypersensitivity reactions to
             monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).

          -  Any history of anaphylaxis or uncontrolled asthma (that is, 3 or more features of
             partially controlled asthma).

          -  Clinically significant (i.e., active) cardiovascular disease: myocardial infarction (<
             6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York
             Heart Association Classification Class II), or serious cardiac arrhythmia requiring
             medication.

          -  Prior cerebrovascular accident/stroke.

          -  Clinically significant carotid artery disease (e.g. prior carotid surgery, symptomatic
             and/or requires treatment)

          -  Inability to comply with study and follow-up procedures as judged by the Investigator.

          -  Known alcohol or drug abuse.