An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer (EV-302)

STATUS

Recruiting
End date

Sep 30, 2027
participants needed

990
sponsor

Astellas Pharma Global Development, Inc.

Send

Updated on 24 October 2022

See if I qualify

systemic therapy

measurable disease

carcinoma

carboplatin

gemcitabine

pembrolizumab

pd-l1

adjuvant chemotherapy

transitional cell carcinoma

metastatic urothelial carcinoma

enfortumab vedotin

Summary

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

Description

Japan PMDA has approved enfortumab vedotin (Padcev) for the treatment of advanced urothelial cancer. The study will continue as a post marketing study in Japan.

This study is being conducted to evaluate the combination of enfortumab vedotin + pembrolizumab versus standard of care gemcitabine + platinum-containing chemotherapy, in subjects with previously untreated locally advanced or metastatic urothelial cancer.

Enfortumab vedotin may be administered for an unlimited number of cycles until a protocol defined reason for study discontinuation occurs. Pembrolizumab may be administered for a maximum of 35 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first. Cisplatin or carboplatin plus gemcitabine may be administered for a maximum of 6 cycles or a protocol-defined reason for study discontinuation occurs, whichever is first.

Details

Condition	Urothelial Cancer
Treatment	cisplatin, carboplatin, Gemcitabine, Pembrolizumab, Enfortumab vedotin
Clinical Study Identifier	NCT04223856
Sponsor	Astellas Pharma Global Development, Inc.
Last Modified on	24 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Histologically documented, unresectable locally advanced or metastatic urothelial carcinoma
	Measurable disease by investigator assessment according to RECIST v1.1
	Participants with prior definitive radiation therapy must have measurable disease per RECIST v1.1 that is outside the radiation field or has demonstrated unequivocal progression since completion of radiation therapy
	Participants must not have received prior systemic therapy for locally advanced or
	Participants that received neoadjuvant chemotherapy with recurrence >12 months from completion of therapy are permitted
	metastatic urothelial carcinoma with the following exceptions
	Participants that received adjuvant chemotherapy following cystectomy with recurrence >12 months from completion of therapy are permitted
	Archival tumor tissue comprising muscle-invasive urothelial carcinoma or a biopsy of metastatic urothelial carcinoma must be provided for PD-L1 testing prior to randomization
	Must be considered eligible to receive cisplatin- or carboplatin-containing
	Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
	chemotherapy, in the investigator's judgment
	Adequate hematologic and organ function
Exclusion Criteria
	Previously received enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugate (ADCs)
	Received prior treatment with a programmed cell death ligand-1 (PD-(L)-1) inhibitor for any malignancy, including earlier stage urothelial cancer (UC), defined as a PD-1 inhibitor or PD-L1 inhibitor
	Received prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor
	Received anti-cancer treatment with chemotherapy, biologics, or investigational agents not otherwise prohibited by exclusion criterion 1-3 that is not completed 4 weeks prior to first dose of study treatment
	Uncontrolled diabetes
	Estimated life expectancy of less than 12 weeks
	Active central nervous system (CNS) metastases
	Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis is permitted
	Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection
	Ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1 or returned to baseline
	History of another invasive malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy
	Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class IV within 6 months prior to randomization
	Receipt of radiotherapy within 2 weeks prior to randomization
	Received major surgery (defined as requiring general anesthesia and >24 hour inpatient hospitalization) within 4 weeks prior to randomization
	Active keratitis or corneal ulcerations
	History of autoimmune disease that has required systemic treatment in the past 2 years
	Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin
	History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
	Prior allogeneic stem cell or solid organ transplant
	Received a live attenuated vaccine within 30 days prior to randomization

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An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer (EV-302)