A Global Expanded Access Program for Enfortumab Vedotin in Patients with Locally Advanced or Metastatic Urothelial Carcinoma (EV-902)

JRCT ID: jRCT2031210099

Registered date:18/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Urothelial Carcinoma
• Date of first enrollment: 26/07/2021
• Target sample size: 350
• Countries of recruitment: France,Japan,Germany,Japan,Belgium,Japan
• Study type: Interventional
• Intervention(s): In this study, enfortumab vedotin will be intravenously administered over a 30 minute period on days 1, 8 and 15 of every 28-day cycle. Participants will be eligible to continue receiving treatment in this expanded access program until they meet a discontinuation criterion or upon marketing authorization and commercial availability of enfortumab vedotin.

Outcome(s)

Primary Outcome

-Adverse events
-Serious adverse events

• Secondary Outcome: Not applicable

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patient has locally advanced or metastatic urothelial carcinoma
2. Patient has previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
3. Patient has no other treatment options available under standard of care.
4. Patient has the following baseline laboratory data:
a.absolute neutrophil count >= 1500/mm^3 (>= 1.5 x 10^9/L)
b.platelet count >= 75,000/mm^3 (>= 75 x 10^9/L)
c.hemoglobin >= 8 g/dL
d.serum bilirubin =< 1.5 x upper limit of normal (ULN) or =< 3 x ULN for patients with Gilbert's disease
e.Creatinine clearance (CrCl) >= 15 mL/min as estimated per institutional standards or as measured by 24-hour urine collection (glomerular filtration rate can also be used instead of CrCl)
f.alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN or =< 3 x ULN for patients with liver metastases
5. Patient has Eastern Cooperative Oncology Group performance status of 0 or 1.
6. Female patient is not pregnant and at least one of the following conditions apply:
a.Not a woman of childbearing potential (WOCBP)
b.WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 2 months after final investigational product (IP) administration.
7. Female patient must agree not to breastfeed starting at screening and throughout the treatment protocol period and for 3 weeks after final IP administration.
8. Female patient must not donate ova starting at first dose of IP and throughout the treatment protocol period and for 2 months after final IP administration.
9. Male patient with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 4 months after final IP administration.
10. Male patient must not donate sperm during the treatment period and for 4 months after final IP administration.
11. Male patient with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the treatment protocol period and for 4 months after final IP administration.
12. Patient agrees not to participate in another interventional study while receiving treatment in the present treatment protocol/participating in the present treatment protocol.

Exclude criteria

1. Patient has previously received treatment in an enfortumab vedotin clinical trial or a clinical trial that included enfortumab vedotin as 1 of the treatment options (even if the patient was not given enfortumab vedotin).
2. Patient is a candidate for any ongoing enfortumab vedotin clinical trial.
3. Patient has ongoing sensory or motor neuropathy grade >= 2.
4. Patient has symptomatic central nervous system metastases.
5. Patient has ongoing clinically significant toxicity (grade 2 or higher with the exception of alopecia) associated with prior treatment.
6. Patient has known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dehydrate, and polysorbate 20); OR patient has known hypersensitivity to biopharmaceuticals produced in Chinese Hamster Ovary cells.
7. Patient completed radiotherapy, major surgery or prior anti-cancer therapy =< 2 weeks before first enfortumab vedotin dose.
8. Patient has history of uncontrolled diabetes mellitus =< 3 months of the first enfortumab vedotin dose. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) >= 8% or HbA1c between 7% and < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
9. Patient has an active viral, bacterial or fungal infection (including hepatitis B, hepatitis C, or human immunodeficiency virus) at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.
10. Patient has recent history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Classes III to IV that is not adequately treated and/or controlled at the time of first enfortumab vedotin dose.
11. Patient has other underlying medical condition that would impair the ability of the patient to receive or tolerate enfortumab vedotin.

Related Information

• Primary Sponsor: Steinberg Joyce