24 Participants Needed

Enfortumab Vedotin for Bladder Cancer

Recruiting at 7 trial locations
MY
JR
GI
SN
Overseen ByScot Niglio, MD, MS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: HAART therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial is testing enfortumab vedotin, a drug that targets and kills cancer cells, in patients with upper urinary tract urothelial carcinoma who can't or won't use cisplatin and are planning surgery. Enfortumab vedotin is a new type of drug that targets a specific protein on cancer cells and delivers a substance that kills these cells.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on therapeutic anticoagulation (blood thinners), you must be on a stable dose. It's best to discuss your specific medications with the trial team.

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

Enfortumab Vedotin has been shown to be effective in treating advanced bladder cancer, with a study reporting a 44% response rate in patients who had previously received other treatments. This drug works by targeting a protein on cancer cells and delivering a toxin to kill them, offering a new option for patients with limited treatment choices.12345

Is Enfortumab Vedotin safe for humans?

Enfortumab Vedotin, also known as Padcev, has been associated with some serious side effects, including high blood sugar, nerve damage, eye problems, skin reactions, and risks to unborn babies. In studies, 73% of patients experienced severe side effects, and up to 47% had skin reactions.12346

What makes the drug Enfortumab Vedotin unique for bladder cancer treatment?

Enfortumab Vedotin is unique because it is the first drug specifically approved for patients with advanced bladder cancer who have already been treated with PD-1/PD-L1 inhibitors and platinum-based chemotherapy. It works as an antibody-drug conjugate targeting Nectin-4, a protein found on cancer cells, and is administered intravenously.12356

Research Team

SN

Scot Niglio, MD, MS

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with high-grade urothelial carcinoma of the upper urinary tract who can't or choose not to take cisplatin and are planning on having surgery. They should have adequate kidney function, hearing loss no worse than Grade 2, a good performance status, stable blood counts and liver enzymes, and not be pregnant or breastfeeding. People with uncontrolled diabetes, recent major surgery, active heart disease or infections like tuberculosis or hepatitis B/C cannot join.

Inclusion Criteria

My blood counts and liver function tests are within the required ranges, and if I have HIV, it's under control.
I have a specific type of bladder cancer that has not spread beyond my pelvis.

Exclusion Criteria

My cancer has spread to other parts of my body.
I've had chemo or radiation for bladder cancer in the last 2 years.
I had a heart attack in the last 6 months.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive enfortumab vedotin at 1.25 g/kg on days 1 and 8 of a 21-day cycle, for a total of three cycles

9 weeks
6 visits (in-person)

Surgery

Participants undergo radical nephroureterectomy, ureterectomy, or nephrectomy, depending on the site of the tumor

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years

Treatment Details

Interventions

  • Enfortumab Vedotin
  • Radical surgery
Trial Overview The study is testing Enfortumab Vedotin's effectiveness and safety in treating cancer before patients undergo standard radical surgery to remove their tumors. It targets those who aren't eligible for cisplatin chemotherapy.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Enfortumab VedotinExperimental Treatment2 Interventions
All patients will receive enfortumab vedotin at 1.25 g/kg on days 1 and 8 of 21 days cycle, for a total of three cycles, followed by radical nephroureterectomy, ureterectomy, or nephrectomy, depending on the site of the tumor and per the clinical decision of the treating urologist.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Astellas Pharma US, Inc.

Industry Sponsor

Trials
90
Recruited
12,900+

Naoki Okamura

Astellas Pharma US, Inc.

Chief Executive Officer since 2023

Not available

Tadaaki Taniguchi

Astellas Pharma US, Inc.

Chief Medical Officer since 2023

MD, PhD

Findings from Research

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.
FDA Approves First Agent to Treat Locally Advanced, Metastatic Urothelial Cancer.Kahl, KL.[2023]
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.
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]
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.
FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma.Chang, E., Weinstock, C., Zhang, L., et al.[2022]

References

FDA Approves First Agent to Treat Locally Advanced, Metastatic Urothelial Cancer. [2023]
Enfortumab Vedotin-ejfv: A First-in-Class Anti-Nectin-4 Antibody-Drug Conjugate for the Management of Urothelial Carcinoma. [2021]
FDA Approval Summary: Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Carcinoma. [2022]
Enfortumab vedotin-ejfv for the treatment of advanced urothelial carcinoma. [2022]
Enfortumab Vedotin: Nursing Perspectives on the Management of Adverse Events in Patients With Locally Advanced or Metastatic Urothelial Carcinoma. [2021]
Toxic epidermal necrolysis after the administration of enfortumab vedotin for urinary bladder urothelial carcinoma. [2023]