A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
4 other identifiers
interventional
329
3 countries
39
Brief Summary
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1. This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin for cohorts 1 to 8 and enfortumab vedotin + pembrolizumab in cohort 9.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2020
Longer than P75 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedStudy Start
First participant enrolled
March 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2025
CompletedResults Posted
Study results publicly available
April 13, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
ExpectedApril 13, 2026
March 1, 2026
5 years
January 9, 2020
February 24, 2026
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cohorts 1-8: Confirmed Overall Response Rate (ORR) (Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V)1.1 Per Investigator Assessment
Confirmed ORR was defined as the percentage of participants whose objective response was confirmed as CR or PR according to RECIST V1.1 per investigator assessment, using exact method based on binomial distribution (Clopper-Pearson).
Up to 20.04 months
Cohort 9: Confirmed ORR (CR and PR) Per RECIST V1.1 Per Investigator Assessment
Confirmed ORR was defined as the percentage of participants whose objective response was confirmed as CR or PR according to RECIST V1.1 per investigator assessment, using exact method based on binomial distribution (Clopper-Pearson).
Up to 12.85 months
Secondary Outcomes (10)
Cohorts 1-8: Duration of Resonse (DOR) Per RECIST V.1.1 Per Investigator Assessment
Up to 20.04 months
Cohorts 1-8: Disease Control Rate (DCR) Per RECIST V1.1 Per Investigator Assessment
Up to 22 months
Cohorts 1-8: Progression Free Survival (PFS) Per RECIST V1.1 Per Investigator Assessment
Up to 22 months
Cohorts 1-8: Overall Survival (OS)
Up to 34 months
Cohorts 1-8: Number of Participants With Treatment-emergent Adverse Events (AEs)
Up to end of treatment + 30 days (32 months)
- +5 more secondary outcomes
Study Arms (9)
Cohort 1: HR+/HER2- breast cancer
EXPERIMENTALParticipants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. HR+/HER2- = Hormone receptor-positive/ human epidermal growth factor receptor 2-negative
Cohort 2: Triple negative breast cancer (TNBC)
EXPERIMENTALParticipants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
Cohort 3: Squamous non-small cell lung cancer
EXPERIMENTALParticipants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
Cohort 4: Non-squamous non-small cell lung cancer
EXPERIMENTALParticipants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
Cohort 5: Head and neck cancer
EXPERIMENTALParticipants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
Cohort 6: Gastric or GEJ or esophageal cancer
EXPERIMENTALParticipants enrolled into Cohort 6 will be reallocated based on disease type and histology into Cohorts 7 or 8. GEJ= gastroesophageal junction
Cohort 7: Gastric and esophageal adenocarcinoma (EAC) including GEJ adenocarcinoma
EXPERIMENTALParticipants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
Cohort 8: Esophageal squamous cell carcinoma (ESCC)
EXPERIMENTALParticipants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
Cohort 9: Head and neck squamous cell carcinoma (HNSCC)
EXPERIMENTALParticipants will receive enfortumab vedotin as an IV infusion on days 1 and 8 of each 21-day cycle. Pembrolizumab will be administered as an IV infusion on day 1 of each 21-day cycle.
Interventions
IV infusion
intravenous (IV) infusion
Eligibility Criteria
You may qualify if:
- Subject is considered an adult according to local regulation at the time of signing the informed consent form (ICF).
- Subject has measurable disease by RECIST Version 1.1.
- Subject has accessible archival tumor tissue from either the primary tumor or a metastatic site, for which source and availability have been confirmed prior to study treatment. If no archival tumor tissue is available, the subject will have a biopsy to obtain tumor tissue prior to study treatment. If the subject is unable to undergo a biopsy due to safety concerns, enrollment into the study must be discussed with the medical monitor.
- For cohort 9 only: Subject should submit archival or fresh tumor tissue sample for programmed cell death-ligand 1 (PD-L1) central testing during screening if no local PD-L1 test result is available. Central test result for PD-L1 will be required prior to subject enrollment. For cohort 9 subjects with local PD-L1 test result confirming CPS ≥ 1, archival or fresh tissue sample for exploratory analysis should be submitted within 5 days of enrollment.
- Subject has ECOG performance status of 0 or 1.
- Subject has the following baseline laboratory data. If a subject has received a recent blood transfusion, the hematology tests must be obtained ≥ 28 days after any blood transfusion.
- absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L
- platelet count ≥ 100 × 10\^9/L
- hemoglobin ≥ 9 g/dL
- serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease
- creatinine clearance (CrCl) ≥ 30 mL/min as estimated per institutional standards or as measured by 24-hour urine collection (glomerular filtration rate \[GFR\] can also be used instead of CrCl).
- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN
- Subject agrees not to participate in another interventional study while receiving study treatment in the present study.
- Additional contraceptive requirements exist for male and female subjects.
- Evidence of progression on or after the last regimen received.
- +64 more criteria
You may not qualify if:
- For All Cohorts:
- Subject has preexisting sensory or motor neuropathy Grade ≥ 2.
- Subject has active central nervous system (CNS) metastases. Subjects with treated CNS metastases are permitted on study if all the following are true:
- CNS metastases have been clinically stable for ≥ 6 weeks prior to screening
- If requiring steroid treatment for CNS metastases, the subject is on a stable dose ≤ 20 mg/day of prednisone or equivalent for ≥ 2 weeks
- Baseline imaging scans show no evidence of new or enlarged brain metastasis
- Subject does not have leptomeningeal disease
- Subject has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
- Subjects with ongoing ≥ Grade 3 immunotherapy-related hypothyroidism or panhypopituitarism are excluded. Subjects with ongoing immunotherapy-related colitis, uveitis, myocarditis or pneumonitis, or subjects with other immunotherapy-related AEs requiring high doses of steroids (\> 20 mg/day of prednisone or equivalent), are excluded. Subject with ≤ Grade 2 immunotherapy-related hypothyroidism or panhypopituitarism may be enrolled when well maintained/controlled on a stable dose of hormone replacement therapy (if indicated).
- Subject has a history of uncontrolled diabetes mellitus within 3 months before the first dose of study treatment. Uncontrolled diabetes (within 3 months before first dose) 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. The lowest HbA1c during the screening period will be used to determine eligibility.
- Subject has prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE) based antibody-drug conjugates (ADCs).
- Subject has a second malignancy diagnosed within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Subjects with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.
- Subject is currently receiving systemic antimicrobial treatment for viral, bacterial, or fungal infection at the time of first dose of study treatment. Routine antimicrobial prophylaxis is permitted.
- Subject has known active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or active hepatitis C (e.g., hepatitis C virus \[HCV\] RNA \[qualitative\] is detected).
- Subject has known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2).
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Global Development, Inc.lead
- Seagen Inc.collaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (39)
Arizona Oncology
Tucson, Arizona, 85711, United States
University of California - San Francisco
San Francisco, California, 94158, United States
University of Colorado
Aurora, Colorado, 80045, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists
Tallahassee, Florida, 32308, United States
Florida Cancer Specialists
West Palm Beach, Florida, 33401, United States
Piedmont Hospital
Atlanta, Georgia, 30318, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northwestern University Medical Center
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202, United States
University of Kansas
Fairway, Kansas, 66205, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901, United States
New York University Langone Health
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10022, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17375, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Mary Crowley Research Center
Dallas, Texas, 75230, United States
University of Texas
Houston, Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
Site CA15003
Ottawa, Ontario, K1H 8L6, Canada
Site JP81004
Nagoya, Aichi-ken, Japan
Site JP81001
Kashiwa, Chiba, Japan
Site JP81005
Chuo-ku, Osaka, Japan
Site JP81007
Ōsaka-sayama, Osaka, Japan
Site JP81011
Kitaadachi-Gun, Saitama, Japan
Site JP81006
Nakatogari, Shizuoka, Japan
Site JP81003
Chūō, Tokyo, Japan
Site JP81002
Koto, Tokyo, Japan
Site JP81010
Okayama, Japan
Related Publications (3)
Muro K, Feinstein T, Baranda J, Bonta I, Yanagitani N, Gersten T, Gandhi L, Kudo T, Fujioka N, Kaplan J, Gorla S, Liu S, Wozniak M, Poondru S, Dillon R, Meng C, Patil T. Enfortumab vedotin in patients with advanced non-small cell lung cancer after disease progression on platinum- and PD-1/PD-L1 inhibitor-containing regimens: Phase 2 international multicenter EV-202 study. Eur J Cancer. 2025 Sep 9;227:115603. doi: 10.1016/j.ejca.2025.115603. Epub 2025 Jul 9.
PMID: 40819431RESULTSwiecicki PL, Yilmaz E, Rosenberg AJ, Fujisawa T, Bruce JY, Meng C, Wozniak M, Zhao Y, Mihm M, Kaplan J, Gorla S, Geiger JL. Phase II Trial of Enfortumab Vedotin in Patients With Previously Treated Advanced Head and Neck Cancer. J Clin Oncol. 2025 Feb 10;43(5):578-588. doi: 10.1200/JCO.24.00646. Epub 2024 Oct 31.
PMID: 39481054RESULTMuro K, Chin K, Maron SB, Braiteh FS, Mitani S, Hara H, Kuboki Y, Mulcahy MF, Baranda JC, Gardner FP, Jin N, Hamauchi S, Kaplan J, Gorla S, Liu S, Wozniak M, Poondru S, Dillon R, Meng C, Kondo S. Phase II trial of enfortumab vedotin in patients with previously treated gastric and esophageal cancers. ESMO Open. 2025 Nov;10(11):105806. doi: 10.1016/j.esmoop.2025.105806. Epub 2025 Oct 23.
PMID: 41135379RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Transparency
- Organization
- Astellas Pharma Global Development, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2020
First Posted
January 13, 2020
Study Start
March 10, 2020
Primary Completion
February 25, 2025
Study Completion (Estimated)
September 30, 2026
Last Updated
April 13, 2026
Results First Posted
April 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.