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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

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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Turkey
State/province [189] 0 0
Edirne
Country [190] 0 0
Turkey
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
Trial website
Trial related presentations / publications
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
clinicaltrials@seagen.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04223856