Enfortumab Vedotin and Pembrolizumab With or Without Chemotherapy vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer

STATUS

Recruiting
participants needed

1095
sponsor

Astellas Pharma Global Development, Inc.

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Updated on 19 February 2024

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cancer

immunomodulator

measurable disease

metastatic urothelial carcinoma

gemcitabine

carboplatin

pembrolizumab

carcinoma

immunomodulators

systemic therapy

transitional cell carcinoma

pd-l1

adjuvant chemotherapy

external beam radiation therapy

enfortumab vedotin

adjuvant

cisplatin

Summary

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together alone or with platinum chemotherapy 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

This study is being conducted to evaluate the combination of enfortumab vedotin + pembrolizumab, with or without platinum-containing chemotherapy, 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, carboplatin, and/or 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
Age	18-100 years
Treatment	Carboplatin, Pembrolizumab, Gemcitabine, Cisplatin, Enfortumab vedotin
Clinical Study Identifier	NCT04223856
Sponsor	Astellas Pharma Global Development, Inc.
Last Modified on	19 February 2024

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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 metastatic urothelial carcinoma with the following exceptions
	Participants that received neoadjuvant chemotherapy with recurrence >12 months from completion of therapy are permitted
	Participants that received adjuvant chemotherapy following cystectomy with recurrence >12 months from completion of therapy are permitted
	Must be considered eligible to receive cisplatin- or carboplatin-containing chemotherapy, in the investigator's judgement
	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
	Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
	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
	Ongoing clinically significant toxicity associated with prior treatment that has not resolved to Grade 1 or returned to baseline
	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
	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
	Known severe ( Grade 3) hypersensitivity to any enfortumab vedotin excipient contained in the drug formulation of enfortumab vedotin
	Active keratitis or corneal ulcerations
	History of autoimmune disease that has required systemic treatment in the past 2 years
	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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Enfortumab Vedotin and Pembrolizumab With or Without Chemotherapy vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer