Enfortumab Vedotin for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Kansas Medical Center

Must not be taking: Steroids, Antimicrobials

Disqualifiers: CNS metastases, Active infections, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: Approximately 2 years or until disease progression

28 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use other cancer treatments or investigational drugs while participating. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Enfortumab Vedotin for treating pancreatic cancer?

Enfortumab Vedotin has been shown to be effective in treating urothelial cancer, with a 44% response rate in patients who had previously received other treatments. While this data is specific to urothelial cancer, it suggests potential effectiveness in other cancers, like pancreatic cancer, due to its mechanism of targeting cancer cells. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults with advanced pancreatic cancer who've had previous treatment. They must have good kidney and liver function, no major recent heart issues or active infections, and can't be on other clinical trials. Women of childbearing age need a negative pregnancy test and agree to use contraception.

Inclusion Criteria

Your liver enzymes (AST and ALT) should not be too high, unless you have cancer that has spread to the liver, in which case they can be a little higher.

Your bilirubin levels in the blood are within a certain range.

My kidney function, measured by creatinine levels, is within the normal range.

Exclusion Criteria

Has a known allergic reaction to any excipient contained in the study drug formulation

I have moderate to severe numbness, tingling, or muscle weakness.

I have not received a live vaccine in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Enfortumab vedotin, 1.25 mg/kg IV on Days 1, 8, 15 every 28 days

Approximately 2 years or until disease progression

Visits on Days 1, 8, 15 of each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Every 3 months

Treatment Details

Interventions

• Enfortumab Vedotin

Trial Overview The study tests Enfortumab Vedotin in patients with advanced pancreatic cancer that has worsened despite treatment. It's an open-label Phase II trial, meaning everyone knows they're getting the drug, not a placebo.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

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

Enfortumab Vedotin is already approved in United States, European Union for the following indications:

Approved in United States as Padcev for:

• Locally advanced or metastatic urothelial cancer

Approved in European Union as Padcev for:

• Locally advanced or metastatic urothelial cancer

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Findings from Research

In a subgroup analysis of 86 Japanese patients with locally advanced or metastatic urothelial carcinoma, enfortumab vedotin (EV) demonstrated a median overall survival of 15.18 months, significantly longer than the 10.55 months observed with standard chemotherapy.

EV also showed a higher confirmed overall response rate (34.4%) compared to standard chemotherapy (21.3%), while having a lower incidence of treatment-related adverse events, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Japanese subgroup analysis of EV-301: An open-label, randomized phase 3 study to evaluate enfortumab vedotin versus chemotherapy in subjects with previously treated locally advanced or metastatic urothelial carcinoma. Matsubara, N., Yonese, J., Kojima, T., et al.[2023]

Enfortumab vedotin (Padcev) is the first FDA-approved treatment specifically for adults with locally advanced or metastatic urothelial cancer who have already undergone treatment with PD-1/PD-L1 inhibitors and platinum-based chemotherapy.

This approval marks a significant advancement in cancer therapy, providing a new option for patients who have limited treatment choices after previous therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approves First Agent to Treat Locally Advanced, Metastatic Urothelial Cancer. Kahl, KL.[2023]

Enfortumab vedotin (PADCEV) received accelerated FDA approval for treating locally advanced or metastatic urothelial cancer in patients who have already undergone specific prior therapies, based on substantial evidence from a study involving 125 patients.

The treatment showed a confirmed objective response rate of 44%, with a median response duration of 7.6 months, although 73% of patients experienced grade 3-4 adverse reactions, highlighting the need for careful monitoring of side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma. Chang, E., Weinstock, C., Zhang, L., et al.[2022]

Enfortumab vedotin-ejfv (EV) is an effective treatment option for adults with locally advanced or metastatic urothelial carcinoma who have already received PD-1/PD-L1 inhibitors and platinum-based chemotherapy, as it targets the Nectin-4 protein.

To maximize the benefits of EV therapy, it is crucial to educate patients and caregivers, monitor for adverse events, and intervene promptly to manage any side effects that may arise during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enfortumab Vedotin: Nursing Perspectives on the Management of Adverse Events in Patients With Locally Advanced or Metastatic Urothelial Carcinoma. Pace, A., Brower, B., Conway, D., et al.[2021]

Enfortumab vedotin-ejfv (EV) is an effective treatment for locally advanced or metastatic urothelial carcinoma (UC), showing a 44% overall response rate and a median overall survival of 11.7 months in heavily pretreated patients.

While EV demonstrates significant antitumor activity, it also presents unique toxicity concerns that require careful monitoring, highlighting the need for further studies to optimize its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enfortumab Vedotin-ejfv: A First-in-Class Anti-Nectin-4 Antibody-Drug Conjugate for the Management of Urothelial Carcinoma. Halford, Z., Anderson, MK., Clark, MD.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Japanese subgroup analysis of EV-301: An open-label, randomized phase 3 study to evaluate enfortumab vedotin versus chemotherapy in subjects with previously treated locally advanced or metastatic urothelial carcinoma. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

FDA Approves First Agent to Treat Locally Advanced, Metastatic Urothelial Cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Enfortumab Vedotin: Nursing Perspectives on the Management of Adverse Events in Patients With Locally Advanced or Metastatic Urothelial Carcinoma. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Enfortumab Vedotin-ejfv: A First-in-Class Anti-Nectin-4 Antibody-Drug Conjugate for the Management of Urothelial Carcinoma. [2021]