| Eligibility |
Inclusion Criteria:
1. Ability of participant OR Legally Authorized Representative (LAR) to understand this
study, and participant or LAR willingness to sign a written informed consent
2. Males and females age = 18 years
3. Subjects with locally advanced, recurrent or metastatic pancreatic adenocarcinoma
after progressing or intolerant to at least one line of systemic therapy
4. ECOG Performance Status 0 - 1 (Appendix A.)
5. Measurable disease by RECIST 1.1
6. Women of childbearing potential must have a negative urine or serum pregnancy test 7
days prior to initiating treatment.
7. Adequate archival tissue from prior biopsy for biomarker evaluation or willingness to
undergo tissue biopsy before treatment starts and on treatment. Patients who, in the
opinion of the investigator, do not have tissue that can be safely biopsied are
excepted.
8. Absolute Neutrophil Count >1.5K/UL NOTE: Patients with established diagnosis of benign
neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion
of treating physician the trial treatment does not pose excessive risk of infection to
the patient.
9. Platelets >100K/UL
10. Hemoglobin = 9 g/dL
11. Serum creatinine = 1.5 x upper limit of normal (ULN) or calculated creatinine
clearance = 50 mL/min using the Cockcroft-Gault equation
12. Total bilirubin = 1.5 x ULN OR direct bilirubin = 1 x ULN
13. Aspartate aminotransferase and alanine aminotransferase = 2.5 x ULN unless liver
metastases are present, in which case they must be = 5 x ULN
14. Women of child-bearing potential and men with partners of child-bearing potential must
agree to practice sexual abstinence or to use the forms of contraception listed in
Child-Bearing Potential/Pregnancy section for the duration of study participation and
- Females: at least 2 months after the last dose of the study medication.
- Males: at least 4 months after the last dose of the study medication.
Exclusion Criteria:
1. Simultaneously enrolled in any therapeutic clinical trial
2. Current or anticipating use of other anti-neoplastic or investigational agents while
participating in this study
3. Diagnosed with a psychiatric illness or is in a social situation that would limit
compliance with study requirements
4. Has a known allergic reaction to any excipient contained in the study drug formulation
5. Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal
infection within 2 weeks prior to the first dose of study treatment.
6. Ongoing sensory or motor neuropathy Grade 2 or higher.
7. Active central nervous system (CNS) metastases. Patients with treated CNS metastases
are permitted on study if all the following are true:
1. CNS metastases have been clinically stable for at least 6 weeks prior to
screening and baseline scans show no evidence of new or enlarged metastasis.
2. If requiring steroid treatment for CNS metastases, the patient is on a stable
dose <10 mg/day of prednisone or equivalent for at least 2 weeks.
3. Patient does not have leptomeningeal disease
8. Patients with conditions requiring high doses of steroids (>10 mg/day of prednisone or
equivalent) or other immunosuppressive medications are excluded. Inhaled or topical
steroids are permitted in the absence of active autoimmune disease.
9. Prior treatment with enfortumab vedotin or other MMAE-based antibody-drug conjugates
(ADCs).
10. Currently receiving systemic antimicrobial treatment for active infection (viral,
bacterial, or fungal) at the time of first dose of enfortumab vedotin. Routine
antimicrobial prophylaxis is permitted.
11. Patients with a positive hepatitis B surface antigen and/or antihepatitis B core
antibody; patients with a negative polymerase chain reaction (PCR) assay are permitted
with either universal prophylaxis or the use of a pre-emptive approach.
12. Active hepatitis C infection or known human immunodeficiency virus (HIV) infection
NOTE: Patients who have been curatively treated for hepatitis C infection are
permitted if they have documented sustained virologic response of 12 weeks. No HIV
testing is required unless mandated by local health authority.
13. Patients with active tuberculosis based on medical history.
14. Documented history of a cerebral vascular event (stroke or transient ischemic attack),
unstable angina, myocardial infarction, or cardiac symptoms (including congestive
heart failure) consistent with NYHA Class III-IV within 6 months prior to the first
dose of enfortumab vedotin.
15. Radiotherapy or major surgery within 2 weeks prior to first dose of study drug.
Patient must have recovered adequately from the toxicity and/or complications from the
intervention prior to starting study treatment.
16. Patients with active keratitis or corneal ulcerations. Patients with superficial
punctate keratitis are allowed if the disorder is being adequately treated in the
opinion of the investigator.
17. History of idiopathic pulmonary fibrosis; organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan.
18. Prior allogeneic stem cell or solid organ transplant.
19. Administration of a live, attenuated vaccine within 30 days prior to first dose of
study drug. Examples of live vaccines include, but are not limited to, the following:
measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG,
and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed
virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,
FluMist®) are live attenuated vaccines and are not allowed.
20. Other underlying medical condition that, in the opinion of the investigator, would
impair the ability of the patient to receive or tolerate the planned treatment and
follow-up; any known psychiatric or substance abuse disorders that would interfere
with cooperating with the requirements of the study.
21. Patients with uncontrolled diabetes. Uncontrolled diabetes is defined as hemoglobin
A1c (HbA1c) =8% or HbA1c 7% to <8% with associated diabetes symptoms (polyuria or
polydipsia) that are not otherwise explained.
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