AzTrials
AzTrials

Pancreatic Ductal AdenocarcinomaPhase 2NCT05915351

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

A Phase 2 study testing Enfortumab vedotin in people with Pancreatic Ductal Adenocarcinoma and Pancreas Adenocarcinoma, run by University of Kansas Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Enfortumab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
30 Jun 2023to 1 Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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.
  • Males: at least 4 months after the last dose of the study medication.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.
  • Patients with active tuberculosis based on medical history.
  • 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.
  • 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.
  • 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.
  • History of idiopathic pulmonary fibrosis; organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  • Prior allogeneic stem cell or solid organ transplant.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66205

Other trials in United States

About this study

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

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

Read the detailed description

Enfortumab vedotin is an antibody-drug conjugate that delivers the microtubule-disrupting agent monomethyl auristatin E (MMAE) to cells expressing Nectin-4. Enfortumab vedotin is FDA approved for bladder cancer.

This is a phase II, open-label, study to evaluate the efficacy, safety and tolerability of Enfortumab vedotin in participants with previously treated locally advanced, recurrent, or metastatic pancreatic adenocarcinoma

Being tested
Enfortumab vedotin
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enfortumab vedotinDrug

    Also called Padcev

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

Study groups in NCT05915351
Study groupRoleWhat they receive
TreatmentExperimentalEnfortumab vedotin, 1.25 mg/kg IV on D 1,8,15 every 28 days
Receives: Drug: Enfortumab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

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

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

Secondary outcomes (5)

  1. Safety and Tolerability

    To determine treatment safety based on toxicities evaluated according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 in patients who have received at least one dose of enfortumab vedotin

    Measured: 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)

  2. Duration of Response (DOR)

    To determine anti-tumor activity by duration of response (DOR)

    Measured: approximately 2 years

  3. Disease Control Rate (DCR)

    To determine anti-tumor activity by disease control rate (DCR)

    Measured: approximately 2 years

  4. Progression Free Survival (PFS)

    To determine progression free survival (PFS)

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

  5. Overall Survival (OS)

    To determine overall survival (OS)

    Measured: Every 3 months for 12 months after End of Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2023
  2. Study start30 Jun 2023
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05915351
Sponsor's protocol ID
STUDY00150104
Status last verified
Apr 2025
First submitted
23 May 2023
Last updated
16 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enfortumab vedotin in people with Pancreatic Ductal Adenocarcinoma and Pancreas Adenocarcinoma, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Every 8 weeks until disease progression or end of study (approximately 2 years), whichever is earlier). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05915351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in