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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04223856




Registration number
NCT04223856
Ethics application status
Date submitted
6/01/2020
Date registered
10/01/2020
Date last updated
27/09/2024

Titles & IDs
Public title
Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
Scientific title
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
Secondary ID [1] 0 0
2019-004542-15
Secondary ID [2] 0 0
SGN22E-003
Universal Trial Number (UTN)
Trial acronym
EV-302
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Enfortumab vedotin
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Gemcitabine

Experimental: Arm A - Enfortumab vedotin + pembrolizumab

Active comparator: Arm B - Gemcitabine + cisplatin or carboplatin

Experimental: Arm C (Not Recruiting) - Enfortumab vedotin + pembrolizumab + Cisplatin or carboplatin


Treatment: Drugs: Enfortumab vedotin
Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle

Treatment: Drugs: Pembrolizumab
IV infusion on Day 1 of every 3-week cycle

Treatment: Drugs: Cisplatin
administered as IV infusion on Day 1 of each 3-week cycle

Treatment: Drugs: Carboplatin
Dosed according to local guidelines and will be administered as IV infusion on Day 1 of each 3-week cycle

Treatment: Drugs: Gemcitabine
IV infusion on Days 1 and 8 of every 3 week cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR) (Arms A and B only, global population)
Timepoint [1] 0 0
Up to approximately 5 years
Primary outcome [2] 0 0
Duration of Overall survival (OS) (Arms A and B only, global population)
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
Objective response rate (ORR) per RECIST v1.1 by BICR (Arms A and B only)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Time to pain progression (TTPP) (Arms A and B only)
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Mean change from baseline in worst pain at Week 26 (Arms A and B only)
Timepoint [3] 0 0
Up to approximately 6 months
Secondary outcome [4] 0 0
Duration of PFS per RECIST v1.1 by investigator assessment (Arms A and B only)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
ORR per RECIST v1.1 by investigator assessment (Arms A and B only)
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
Duration of response (DOR) per RECIST v1.1 by BICR (Arms A and B only)
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
DOR per RECIST v1.1 by investigator assessment (Arms A and B only)
Timepoint [7] 0 0
Up to approximately 5 years
Secondary outcome [8] 0 0
Disease control rate (DCR) per RECIST v1.1 by BICR (Arms A and B only)
Timepoint [8] 0 0
Up to approximately 5 years
Secondary outcome [9] 0 0
DCR per RECIST v1.1 by investigator assessment (Arms A and B only)
Timepoint [9] 0 0
Up to approximately 5 years
Secondary outcome [10] 0 0
Change from baseline in patient reported outcome assessment measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L)
Timepoint [10] 0 0
Up to approximately 5 years
Secondary outcome [11] 0 0
Mean scores in patient reported outcome assessment measured by the EQ-5D-5L
Timepoint [11] 0 0
Up to approximately 5 years
Secondary outcome [12] 0 0
Change from baseline in patient reported outcome assessment measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
Timepoint [12] 0 0
Up to approximately 5 years
Secondary outcome [13] 0 0
Mean scores in patient reported outcome assessment measured by EORTC QLQ-C30
Timepoint [13] 0 0
Up to approximately 5 years
Secondary outcome [14] 0 0
Incidence of adverse events (AEs)
Timepoint [14] 0 0
Up to approximately 5 years
Secondary outcome [15] 0 0
Incidence of laboratory abnormalities
Timepoint [15] 0 0
Up to approximately 5 years
Secondary outcome [16] 0 0
Treatment discontinuation rate due to AEs
Timepoint [16] 0 0
Up to approximately 5 years

Eligibility
Key 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 judgment
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2027
Actual
Sample size
Target
Accrual to date
Final
886
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site AU61003 - Box Hill
Recruitment hospital [2] 0 0
Site AUS61001 - Douglas
Recruitment hospital [3] 0 0
Site AUS61004 - Heidelberg
Recruitment hospital [4] 0 0
Site AUS61002 - Macquarie Park
Recruitment hospital [5] 0 0
Site AUS61006 - South Australia
Recruitment hospital [6] 0 0
Site AU61005 - South Brisbane
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [5] 0 0
5112 - South Australia
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane
Recruitment outside Australia
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United States of America
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Arizona
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California
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Mendoza
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Rosario
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San Miguel
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Tucuman
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Viedma
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Aalborg
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Gottingen
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Herne
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Lubeck
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Mannheim
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Munchen
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Ulm
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Szolnok
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Haifa
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Holon
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Kfar Saba
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Petach Tikva
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Rehovot
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Torrette
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Okayama
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Sapporo
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Tokushima
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Toyama
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Ube
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Russian Federation
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Barnaul
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Russian Federation
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Leningradskaya Oblast'
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Russian Federation
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Russian Federation
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Nizhniy Novgorod
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Krung Thep Maha Nakhon
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Muang
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Antalya
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Edirne
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State/province [190] 0 0
Istanbul
Country [191] 0 0
Turkey
State/province [191] 0 0
Konya
Country [192] 0 0
Turkey
State/province [192] 0 0
Malatya
Country [193] 0 0
United Kingdom
State/province [193] 0 0
Glasgow
Country [194] 0 0
United Kingdom
State/province [194] 0 0
London
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Oxford
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Plymouth
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Preston
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Sheffield
Country [199] 0 0
United Kingdom
State/province [199] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Global Development, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Seagen Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT04223856
Trial related presentations / publications
Hoimes CJ, Flaig TW, Milowsky MI, Friedlander TW, Bilen MA, Gupta S, Srinivas S, Merchan JR, McKay RR, Petrylak DP, Sasse C, Moreno BH, Yu Y, Carret AS, Rosenberg JE. Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer. J Clin Oncol. 2023 Jan 1;41(1):22-31. doi: 10.1200/JCO.22.01643. Epub 2022 Aug 30.
Public notes

Contacts
Principal investigator
Name 0 0
Zejing Wang, MD, PhD
Address 0 0
Seagen Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Seagen Inc. Trial Information Support
Address 0 0
Country 0 0
Phone 0 0
866-333-7436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04223856