Enfortumab Vedotin in Previously Treated Locally Advanced or Metastatic Pancreatic Cancer (EPIC) (NCT05915351) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Enfortumab Vedotin in Previously Treated Locally Advanced or Metastatic Pancreatic Cancer (EPIC)
United States28 participantsStarted 2023-06-30
Plain-language summary
A Phase II Open-Label Study of Enfortumab Vedotin in Patients with Previously Treated Locally Advanced, Recurrent, or Metastatic Pancreatic Adenocarcinoma (EPIC)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
✓. Males and females age ≥ 18 years
✓. Subjects with locally advanced, recurrent or metastatic pancreatic adenocarcinoma after progressing or intolerant to at least one line of systemic therapy
✓. ECOG Performance Status 0 - 1 (Appendix A.)
✓. Measurable disease by RECIST 1.1
✓. Women of childbearing potential must have a negative urine or serum pregnancy test 7 days prior to initiating treatment.
✓. 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.
✓. 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.
Exclusion criteria
✕. Simultaneously enrolled in any therapeutic clinical trial
✕. Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
✕
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: Every 8 weeks until disease progression or end of study (approximately 2 years), whichever is earlier
. Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
✕. Has a known allergic reaction to any excipient contained in the study drug formulation
✕. 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.
✕. Ongoing sensory or motor neuropathy Grade 2 or higher.
✕. Active central nervous system (CNS) metastases. Patients with treated CNS metastases are permitted on study if all the following are true:
✕. 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.