Enfortumab Vedotin in Previously Treated Locally Advanced or Metastatic Pancreatic Cancer (EPIC)

NCT05915351 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00150104
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase II Open-Label Study of Enfortumab Vedotin in Patients with Previously Treated Locally Advanced, Recurrent, or Metastatic Pancreatic Adenocarcinoma (EPIC)

Conditions

Pancreatic Ductal Adenocarcinoma; Pancreas Adenocarcinoma; Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  To determine anti-tumor activity by overall response rate (ORR) using RECIST 1.1

  Every 8 weeks until disease progression or end of study (approximately 2 years), whichever is earlier

Secondary Outcomes (5)

• Safety and Tolerability

  Adverse Event Collection and Review will occur on Days 1,8,15 for each 28-day cycle until disease progression or end of treatment (approximately 2 years)

• Duration of Response (DOR)

  approximately 2 years

• Disease Control Rate (DCR)

  approximately 2 years

• Progression Free Survival (PFS)

  Every 8 weeks until disease progression or subsequent therapy assessed up to 2 years

• Overall Survival (OS)

  Every 3 months for 12 months after End of Treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Enfortumab vedotin, 1.25 mg/kg IV on D 1,8,15 every 28 days

Drug: Enfortumab vedotin

Interventions

Enfortumab vedotin DRUG

Enfortumab vedotin 1.25 mg/kg on D1, D8, D15 every 28 days

Also known as: Padcev

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Platelets \>100K/UL
• Hemoglobin ≥ 9 g/dL
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation
• Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN
• Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
• 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.

You may not qualify if:

• Simultaneously enrolled in any therapeutic clinical trial
• Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
• 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.
• 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.
• Patient does not have leptomeningeal disease
• 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.
• Prior treatment with enfortumab vedotin or other MMAE-based antibody-drug conjugates (ADCs).
• 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.
• 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.
• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Cancer Center

Kansas City, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

enfortumab vedotin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 23, 2023
• Study Start: June 30, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)