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TerminatedNCT03288545EV-103Updated Mar 24, 2026

A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer

A Phase 1/2 interventional study of enfortumab vedotin (EV) and pembrolizumab in Carcinoma, Transitional Cell, Urinary Bladder Neoplasms and Urologic Neoplasms, sponsored by Astellas Pharma Global Development, Inc.. Terminated at 106 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Astellas Pharma Global Development, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Sponsor stopped the study after meeting enrollment targets and primary objectives, and after collecting sufficient data for planned regulatory filings. The decision was not due to safety concerns, futility, or any regulatory request.
Phase
Phase 1/2
Study type
Interventional
Enrollment
348
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.

Read the detailed description

This study will examine the safety and anticancer activity of enfortumab vedotin (EV) given intravenously as monotherapy and in combination with other anticancer therapies as first line (1L) and second line (2L) treatment for patients with urothelial cancer. The primary goal of the study is to determine the safety, tolerability, and efficacy of enfortumab vedotin alone and in combination with pembrolizumab and/or chemotherapy. The study will be conducted in multiple parts:

Locally advanced or metastatic urothelial cancer:

  • Dose escalation

  • Expansion

    • Part 1: Cohorts A and Optional B
    • Part 2: Cohorts D, E, and Optional F
    • Part 3: Cohort G.

  • Randomized Cohort K

    • EV Monotherapy Arm
    • EV Combination Arm

Muscle invasive bladder cancer:

  • Cohort H
  • Optional Cohort J
  • Cohort L
02

Conditions studied

  • Carcinoma, Transitional Cell
  • Urinary Bladder Neoplasms
  • Urologic Neoplasms
  • Renal Pelvis Neoplasms
  • Urothelial Cancer
  • Ureteral Neoplasms
  • Urethral Neoplasms

Keywords

  • ASG-22ME
  • ASG-22CE
  • Antibody-drug conjugate
  • Antineoplastic agents
  • CPI
  • Enfortumab vedotin
  • MIBC
  • Locally advanced urothelial cancer
  • Cisplatin
  • Drug therapy
  • Carboplatin
  • Metastatic urothelial cancer
  • Nectin-4
  • Gemcitabine
  • Muscle invasive bladder cancer
  • Checkpoint Inhibitors
  • Pembrolizumab
  • PD-1 inhibitor
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Locally advanced or metastatic urothelial cancer (la/mUC) - Cohorts A, B, D, E, F, G and K.

    • Histologically documented la/mUC, including squamous differentiation or mixed cell types.
    • An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2: Participants with ECOG performance status of 2 must meet the following additional criteria: hemoglobin ≥10 g/dL, GFR ≥50 mL/min, may not have NYHA Class III heart failure.
    • Eligible for pembrolizumab (Dose-escalation cohorts, Cohorts A, B, G and K Combination Arm).
    • Dose-escalation cohorts: Ineligible for first-line cisplatin-based chemotherapy and no prior treatment for la/mUC, or have disease progression following at least 1 platinum-containing treatment.
    • Cohort A: Ineligible for cisplatin-based chemotherapy and no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months.
    • Cohort B: Must have disease progression during/following treatment with at least 1 platinum-containing regimen for la/mUC or disease recurrence.
    • Cohort D: Eligible for cisplatin-based chemotherapy and no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months.
    • Cohort E: Ineligible for cisplatin-based chemotherapy, eligible for carboplatin, and no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months.
    • Cohort F: Ineligible for platinum-based chemotherapy, or disease progression during/following at least 1 prior treatment for la/mUC. Eligible for gemcitabine.
    • Cohort G: Eligible for platinum-based chemotherapy (either cisplatin or carboplatin) and no prior treatment for la/mUC. No prior adjuvant/neoadjuvant platinum-based therapy in at least 12 months.
    • Cohort K: Ineligible for cisplatin-based chemotherapy due to at least 1 of the following: Glomerular filtration rate (GFR) \<60 mL/min and ≥30 mL/min, ECOG performance status of 2, NCI CTCAE Version 4.03 Grade ≥2 hearing loss, New York Heart Association (NYHA) Class III heart failure. No prior systemic treatment for locally advanced or metastatic disease. No adjuvant/neoadjuvant platinum-based therapy within 12 months prior to randomization.

  • Muscle Invasive Bladder Cancer (MIBC)- Cohorts H, J and L.

    • Histologically confirmed MIBC with predominant >50% urothelial histology: Cohorts H and J: Clinical stage cT2-T4aN0M0; Cohort L: Clinical stage cT2-T4aN0M0 or cT1-T4aN1M0: Participants with pT1 disease are eligible only if they have N1 disease on imaging. Mixed cell types are eligible if urothelial cancer is predominant (>50%); Participants with plasmacytoid and/or neuroendocrine tumors are ineligible regardless of component percentage. Urothelial tumors not originating in the bladder (eg, upper tract tumors, urethral tumors) are ineligible.
    • Must be cisplatin-ineligible.
    • Cohort-specific eligibility: Cohort J, H, and L: No prior systemic treatment, chemoradiation, or radiation therapy for MIBC. May have received prior intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy for non-MIBC; Cohort J: Eligible for pembrolizumab.
    • ECOG performance status of 0, 1, or 2.
    • Anticipated life expectancy of ≥3 months.
    • Tumor samples with an associated pathology report from the diagnostic transurethral resection of a bladder tumor done 90 days prior to the first dose of study treatment must be available prior to enrollment and determined to be sufficient for pathology review and biomarker analysis.
    • Participants must be deemed eligible for RC+PLND.

Exclusion criteria

Exclusion Criteria:

  • la/mUC - Cohorts A, B, D, E, F, G, and K

    • Received any prior treatment with a PD-1 inhibitor, PD-L1 inhibitor, or PD-L2 inhibitor, except Cohort F.
    • Received any prior treatment with stimulatory or co-inhibitory T-cell receptor agents, such as CD137 agonists, OX-40 agonists, or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors (except Cohort F).
    • Ongoing sensory or motor neuropathy Grade 2 or higher.
    • Active central nervous system (CNS) metastases.
    • Ongoing clinically significant toxicity (Grade 2 or greater) associated with prior treatment (including radiotherapy or surgery).
    • Conditions requiring high doses of steroids or other immunosuppressive medications.
    • Prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).
    • Uncontrolled diabetes mellitus.

  • MIBC - Cohorts H, J, and L

    • Received prior systemic treatment, chemoradiation, and/or radiation therapy of muscle invasive bladder cancer.
    • Received any prior treatment with a CPI.
    • Received any prior treatment with stimulatory or co-inhibitory T-cell receptor agents, such as CD137 agonists, CTLA-4 inhibitors, or OX-40 agonists.
    • For participants in Cohort H, evidence of nodal disease on imaging. For participants in Cohort L, ≥N2 nodal disease on imaging.
    • Participant has undergone partial cystectomy of the bladder to remove any NMIBC or MIBC.
    • Ongoing sensory or motor neuropathy Grade 2 or higher.
    • Conditions requiring high doses of steroids or other immunosuppressive medications.
    • Prior treatment with enfortumab vedotin or other MMAE-based ADCs for urothelial cancer.
    • Participants with a history of another invasive malignancy within 3 years before first dose of study drug.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
348 participants (actual)

Study arms

  • Experimental
    EV + Pembrolizumab in cisplatin-ineligible 1L and in 2L

    Dose Escalation: Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days

    Drug: enfortumab vedotin (EV) · Drug: pembrolizumab

  • Experimental
    Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1L

    Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days

    Drug: enfortumab vedotin (EV) · Drug: pembrolizumab

  • Experimental
    Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2L

    Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days

    Drug: enfortumab vedotin (EV) · Drug: pembrolizumab

  • Experimental
    Cohort D: Enfortumab Vedotin + Cisplatin in 1L

    Enfortumab vedotin on days 1 and 8 plus cisplatin on day 1 every 21 days

    Drug: enfortumab vedotin (EV) · Drug: cisplatin

  • Experimental
    Cohort E: Enfortumab Vedotin + Carboplatin in 1L

    Enfortumab vedotin on days 1 and 8 plus carboplatin on day 1 every 21 days

    Drug: enfortumab vedotin (EV) · Drug: carboplatin

  • Experimental
    Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2L

    Enfortumab vedotin and gemcitabine on days 1 and 8 every 21 days

    Drug: enfortumab vedotin (EV) · Drug: gemcitabine

  • Experimental
    Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L

    Enfortumab vedotin on days 1 and 8 plus cisplatin or carboplatin on day 1 plus pembrolizumab on day 1 every 21 days

    Drug: enfortumab vedotin (EV) · Drug: pembrolizumab · Drug: cisplatin · Drug: carboplatin

  • Experimental
    Cohort H: Enfortumab vedotin in MIBC neoadjuvant setting

    Enfortumab vedotin on days 1 and 8 every 21 days

    Drug: enfortumab vedotin (EV)

  • Experimental
    Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant setting

    Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days

    Drug: enfortumab vedotin (EV) · Drug: pembrolizumab

  • Experimental
    Randomized Cohort K: Enfortumab Vedotin Monotherapy

    Enfortumab vedotin on days 1 and 8 every 21 days

    Drug: enfortumab vedotin (EV)

  • Experimental
    Randomized Cohort K: Enfortumab Vedotin + Pembrolizumab

    Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days

    Drug: enfortumab vedotin (EV) · Drug: pembrolizumab

  • Experimental
    Cohort L: Enfortumab vedotin in MIBC in perioperative setting

    Enfortumab vedotin on days 1 and 8 and every 21 days

    Drug: enfortumab vedotin (EV)

Interventions

  • Drugenfortumab vedotin (EV)

    Intravenous (IV) infusion on days 1 and 8 every 21 days

    Also known as: ASG-22CE, ASG-22ME, PADCEV

  • Drugpembrolizumab

    IV infusion on day 1 every 21 days

    Also known as: Keytruda

  • Drugcisplatin

    IV infusion on day 1 every 21 days

  • Drugcarboplatin

    IV infusion on day 1 every 21 days

  • Druggemcitabine

    IV infusion on days 1 and 8 every 21 days

05

What researchers measure

Primary outcomes

  1. Type, incidence, severity, seriousness, and relatedness of adverse events (Dose escalation and Expansion Parts 1 to 3 cohorts only)

    Descriptive statistics will be used to summarize results.

    Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated.

  2. Type, incidence, and severity of laboratory abnormalities (Dose escalation and Expansion Parts 1 to 3 cohorts only)

    Descriptive statistics will be used to summarize results.

    Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated.

  3. Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) (Cohort K only)

    The proportion of patients with confirmed complete response (CR) or partial response (PR) according to RECIST 1.1

    Time frame: Up to 3 years

  4. Pathological complete response (pCR) rate per central pathology review (MIBC cohorts only)

    The proportion of patients with absence of viable tumor tissue at the time of radical cystectomy.

    Time frame: Up to approximately 5 months

Secondary outcomes

  1. Incidence of dose-limiting toxicity (DLT)

    Incidence of DLTs (dose-escalation expansion Cohorts D, E, F, and the first 6 patients of Cohort G).

    Time frame: 21 days

  2. Confirmed ORR by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)

    The proportion of patients with confirmed CR or PR according to RECIST 1.1.

    Time frame: Up to 3 years

  3. Confirmed ORR by BICR according to RECIST 1.1 (Dose escalation and Cohort A only)

    The proportion of patients with confirmed CR or PR according to RECIST 1.1

    Time frame: Up to 3 years

  4. Confirmed ORR by investigator assessment per the modified RECIST 1.1 for immune-based therapeutics (iRECIST) (Dose escalation and Part 1-3 cohorts with pembrolizumab only)

    The proportion of patients with confirmed CR or PR according to iRECIST.

    Time frame: Up to 3 years

  5. Disease control rate (DCR) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)

    Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1.

    Time frame: Up to 5 years

  6. DCR by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only)

    Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1

    Time frame: Up to 3 years

  7. DCR by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts using pembrolizumab only)

    Proportion of patients with CR, PR, or SD according to iRECIST.

    Time frame: Up to 3 years

  8. Duration of response (DOR) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)

    The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD per RECIST 1.1) or to death due to any cause, whichever comes first.

    Time frame: Up to 5 years

  9. DOR by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only)

    The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD per RECIST 1.1 or to death due to any cause, whichever comes first

    Time frame: Up to 5 years

  10. DOR by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts with pembrolizumab only)

    The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD per iRECIST or to death due to any cause, whichever comes first.

    Time frame: Up to 5 years

  11. Progression free survival on study therapy (PFS) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)

    The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1) on or following study therapy, or to death due to any cause, whichever comes first.

    Time frame: Up to 5 years

  12. PFS by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only)

    The time from start of study treatment to first documentation of objective tumor progression (PD per RECIST 1.1) on or following study therapy, or to death due to any cause, whichever comes first

    Time frame: Up to 5 years

  13. PFS by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts with pembrolizumab only)

    The time from start of study treatment to first documentation of objective tumor progression (PD per iRECIST) on or following study therapy, or to death due to any cause, whichever comes first.

    Time frame: Up to 5 years

  14. Event-free (EFS) on study therapy by BICR (Cohort L only)

    The time from the start of study treatment to the first occurrence of any of the following events: (1) Radiographic disease progression precluding a curative intent surgery as assessed by BICR prior to RC+PLND. (2) Failure to undergo RC+PLND for participants with residual muscle-invasive disease and/or any radiographic disease present. (3) Gross residual disease left behind at time of RC+PLND. (4) Local or distant recurrence post-RC as assessed by CT or MRI and/or biopsy. (5) Death from any cause.

    Time frame: Up to 3 years

  15. Event-free (EFS) on study therapy by investigator assessment (MIBC cohorts only)

    The time from the start of study treatment to the first occurrence of any of the following events: (1) Radiographic disease progression precluding a curative intent surgery as assessed by BICR prior to RC+PLND. (2) Failure to undergo RC+PLND for participants with residual muscle-invasive disease and/or any radiographic disease present. (3) Gross residual disease left behind at time of RC+PLND. (4) Local or distant recurrence post-RC as assessed by CT or MRI and/or biopsy. (5) Death from any cause.

    Time frame: Up to 3 years

  16. Overall survival (OS) (all cohorts)

    The time from start of study treatment to date of death due to any cause.

    Time frame: Up to 5 years

  17. Pharmacokinetics (PK) parameter for enfortumab vedotin: Maximum concentration (Cmax) (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)

    Cmax will be derived from the PK blood samples collected.

    Time frame: Through 2 cycles of treatment, up to 42 days

  18. PK parameter for monomethyl auristatin E (MMAE): Cmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)

    Cmax will be derived from the PK blood samples collected.

    Time frame: Through 2 cycles of treatment, up to 42 days

  19. PK parameter for total antibody (Tab): Cmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)

    Cmax will be derived from the PK blood samples collected.

    Time frame: Through 2 cycles of treatment, up to 42 days

  20. Incidence of antitherapeutic antibodies (ATA) to enfortumab vedotin (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)

    Blood samples for ATA analysis will be collected.

    Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, approximately 3 years anticipated.

  21. PK parameter for enfortumab vedotin: Time to maximum concentration (Tmax) (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)

    Tmax will be derived from the PK blood samples collected.

    Time frame: Through 2 cycles of treatment, up to 42 days

  22. PK parameter for MMAE: Tmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)

    Tmax will be derived from the PK blood samples collected.

    Time frame: Through 2 cycles of treatment, up to 42 days

  23. PK parameter for Tab: Tmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)

    Tmax will be derived from the PK blood samples collected.

    Time frame: Through 2 cycles of treatment, up to 42 days

  24. PK parameter for enfortumab vedotin: Area under the concentration-time curve (AUC) (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)

    AUC will be derived from the PK blood samples collected.

    Time frame: Through 2 cycles of treatment, up to 42 days

  25. PK parameter for MMAE: AUC (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)

    AUC will be derived from the PK blood samples collected.

    Time frame: Through 2 cycles of treatment, up to 42 days

  26. PK parameter for Tab: AUC (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)

    AUC will be derived from the PK blood samples collected.

    Time frame: Through 2 cycles of treatment, up to 42 days

  27. Pathologic downstaging (pDS) rate by central pathology review (MIBC cohorts only)

    The pDS rate is defined as patients with tumors \<pT2 and N0 in examined tissue from radical cystectomy (RC) and pelvic lymph node dissection (PLND).

    Time frame: Up to approximately 5 months

  28. Disease-free survival (DFS) by investigator assessment (MIBC cohorts only)

    DFS is defined as the time from RC to the time of first occurrence of a DFS event, including local recurrence of urothelial cancer (UC), urinary tract recurrence of UC, distant metastasis of UC, or death from any cause.

    Time frame: Up to approximately 5 years

  29. DFS by BICR (Cohort L only)

    DFS is defined as the time from RC to the time of first occurrence of a DFS event

    Time frame: Up to 3 years

  30. Type, incidence, severity, seriousness, and relatedness of AEs (Randomized Cohort K and MIBC cohorts only)

    Descriptive statistics will be used to summarize results.

    Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to approximately 3 years

  31. Type, incidence, and severity of laboratory abnormalities (Randomized Cohort K and MIBC cohorts only)

    Descriptive statistics will be used to summarize results.

    Time frame: Through 1 month following last dose, or end-of-treatment visit whichever is later, up to approximately 3 years

  32. Percentage of planned radical cystectomy and pelvic lymph node dissections (RC+PLND) delayed due to treatment-related AEs (MIBC cohorts only)

    Delayed is defined as greater than 12 weeks after the last dose of treatment.

    Time frame: Up to approximately 5 months

06

Study locations

106 sites
  • Alaska Urological Institute
    Anchorage, Alaska 99503, United States
  • Banner MD Anderson Cancer Center
    Gilbert, Arizona 85234, United States
  • Mayo Clinic Arizona
    Phoenix, Arizona 85054, United States
  • Arizona Oncology Associates, PC - HOPE
    Tucson, Arizona 85710, United States
  • Highlands Oncology Group
    Fayetteville, Arkansas 72703, United States
  • Tower Hematology Oncology Medical Group
    Beverly Hills, California 90211, United States
  • UC San Diego / Moores Cancer Center
    La Jolla, California 92093, United States
  • University of California Irvine - Newport
    Orange, California 92868, United States
  • University of California, Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • University of California at San Francisco
    San Francisco, California 94134, United States
  • Saint Joseph Heritage Medical Group
    Santa Rosa, California 95403, United States
  • Stanford Cancer Center / Blood & Marrow Transplant Program
    Stanford, California 94305, United States
  • Kaiser Permanente Southern California
    Woodland Hills, California 91367, United States
  • Rocky Mountain Cancer Centers - Aurora
    Aurora, Colorado 80012, United States
  • University of Colorado Hospital / University of Colorado
    Aurora, Colorado 80045-0510, United States
  • Yale Cancer Center
    New Haven, Connecticut 06520, United States
  • Eastern CT Hematology and Oncology Associates
    Norwich, Connecticut 06360, United States
  • Georgetown University Medical Center
    Washington D.C., District of Columbia 20007, United States
  • Boca Raton Regional Hospital / Lynn Cancer Institute
    Boca Raton, Florida 33486, United States
  • Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
    Fort Lauderdale, Florida 33308, United States
  • Mayo Clinic Florida
    Jacksonville, Florida 32224, United States
  • University of Miami
    Miami, Florida 33136, United States
  • Piedmont Cancer Institute
    Atlanta, Georgia 30309, United States
  • Winship Cancer Institute / Emory University School of Medicine
    Atlanta, Georgia 30322, United States
  • University of Chicago Medical Center
    Chicago, Illinois 60637-1470, United States
  • Decatur Memorial Hospital - Illinois
    Decatur, Illinois 62526, United States
  • Northwestern Medicine Cancer Center - Kishwaukee / Kishwaukee Cancer Center
    DeKalb, Illinois 60115, United States
  • Northwestern Medicine Cancer Center Delnor
    Geneva, Illinois 60134, United States
  • Cardinal Bernardin Cancer Center / Loyola University Medical Center
    Maywood, Illinois 60153, United States
  • Northwestern Medicine Cancer Center - Warrenville / Central DuPage Hospital - Cancer Care
    Warrenville, Illinois 60555, United States
  • University of Kansas Cancer Center
    Westwood, Kansas 66205, United States
  • Tulane University Hospital and Clinic
    New Orleans, Louisiana 70112, United States
  • Ochsner Clinic Foundation
    New Orleans, Louisiana 70121, United States
  • Maryland Oncology Hematology, P.A.
    Silver Spring, Maryland 20904, United States
  • Southcoast Centers for Cancer Care - Fairhaven Site
    Fairhaven, Massachusetts 02719, United States
  • University of Michigan Comprehensive Cancer Center
    Ann Arbor, Michigan 48109, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • McLaren Greater Lansing Hospital
    Lansing, Michigan 48910, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39213, United States
  • Washington University School of Medicine - Siteman Cancer Center
    St Louis, Missouri 63110, United States
  • Nebraska Hematology Oncology P.C.
    Lincoln, Nebraska 68506, United States
  • OptumCare Cancer Center
    Las Vegas, Nevada 89102, United States
  • Memorial Sloan Kettering Cancer Center - Basking Ridge
    Basking Ridge, New Jersey 07920, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Memorial Sloan Kettering Cancer Center - Monmouth
    Middletown, New Jersey 07748, United States
  • Memorial Sloan Kettering Cancer Center - Bergen
    Montvale, New Jersey 07645, United States
  • University of New Mexico Cancer Center
    Albuquerque, New Mexico 87106, United States
  • New York Oncology Hematology, P.C.
    Albany, New York 12206, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • Memorial Sloan Kettering Cancer Center - Commack
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Cancer Center - Westchester
    Harrison, New York 10604, United States
  • Northwell Cancer Center / Monter Cancer Center
    Lake Success, New York 11042, United States
  • NYU Winthrop Hospital
    Mineola, New York 11501, United States
  • New York University (NYU) Cancer Institute
    New York, New York 10016, United States
  • Weill Cornell Medical College
    New York, New York 10065, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10087-9049, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • Memorial Sloan Kettering Cancer Center - Nassau
    Uniondale, New York 11553, United States
  • UNC Lineberger Comprehensive Cancer Center / University of North Carolina
    Chapel Hill, North Carolina 27599, United States
  • Levine Cancer Institute
    Charlotte, North Carolina 28204, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Vidant Medical Center
    Greenville, North Carolina 27834, United States
  • Gabrail Cancer Center Research, LLC
    Canton, Ohio 44718, United States
  • Case Western Reserve University / University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
  • Toledo Clinic Cancer Center
    Toledo, Ohio 43623, United States
  • CMOH Broomall
    Broomall, Pennsylvania 19008, United States
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Allegheny General Hospital
    Pittsburgh, Pennsylvania 15212, United States
  • Medical University of South Carolina/Hollings Cancer Center
    Charleston, South Carolina 29425, United States
  • Saint Francis Hospital Cancer Center
    Greenville, South Carolina 29607, United States
  • Carolina Urologic Research Center
    Myrtle Beach, South Carolina 29572, United States
  • Sarah Cannon Research Institute
    Chattanooga, Tennessee 37404, United States
  • Tennessee Oncology / Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
  • Texas Oncology - Fort Worth Cancer Center
    Fort Worth, Texas 76104, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
  • Texas Oncology - Tyler
    Tyler, Texas 75702, United States
  • Utah Cancer Specialists
    Salt Lake City, Utah 84106, United States
  • University of Virginia
    Charlottesville, Virginia 22903, United States
  • Virginia Oncology Associates - Norfolk
    Norfolk, Virginia 23502, United States
  • Medical Oncology Associates
    Spokane, Washington 99208, United States
  • Medical College of Wisconsin (Milwaukee)
    Milwaukee, Wisconsin 53226, United States
  • Site CA11008
    East Brampton, Ontario L6R 3J7, Canada
  • Site CA11011
    Kingston, Ontario K7L 2V7, Canada
  • Site CA11001
    Toronto, Ontario M5G 2M9, Canada
  • Site CA11005
    Montreal, Quebec H3T1E2, Canada
  • Site CA11013
    Montreal, Quebec H4A3J1, Canada
  • Site CA11002
    Sherbrooke, Quebec J1H 5N4, Canada
  • Site FR33008
    Bordeaux, 33000, France
  • Site FR33005
    Dijon, 21000, France
  • Site FR33003
    Lyon, 69008, France
  • Site FR33004
    Marseille, 13273, France
  • Site FR33010
    Moselle, 54519, France
  • Site FR33002
    Nice, 06189, France
  • Site FR33006
    Pierre-Bénite, 69310, France
  • Site FR33001
    Strasbourg, 67200, France
  • Site IT39002
    Terni, 05100, Italy
  • Site PR78701
    Rio Piedras, 00935, Puerto Rico
  • Site ES34006
    Barcelona, 08041, Spain

Showing the first 100 of 106 sites across 6 countries.

07

References and documents

Publications

  • Milowsky MI, O'Donnell PH, Hoimes CJ, Petrylak DP, Flaig TW, Moon HH, Friedlander TW, Mar N, McKay RR, Srinivas S, Gravis G, Ramamurthy C, Bupathi M, Bracarda S, Wright P, Hepp Z, Carret AS, Yu Y, Dillon R, Kataria R, Beaumont JL, Purnajo I, Rosenberg JE. Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab. J Clin Oncol. 2024 Apr 20;42(12):1403-1414. doi: 10.1200/JCO.23.01547. Epub 2024 Jan 12. PubMed 38215355 ↗
  • O'Donnell PH, Milowsky MI, Petrylak DP, Hoimes CJ, Flaig TW, Mar N, Moon HH, Friedlander TW, McKay RR, Bilen MA, Srinivas S, Burgess EF, Ramamurthy C, George S, Geynisman DM, Bracarda S, Borchiellini D, Geoffrois L, Maroto Rey JP, Ferrario C, Carret AS, Yu Y, Guseva M, Homet Moreno B, Rosenberg JE. Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer. J Clin Oncol. 2023 Sep 1;41(25):4107-4117. doi: 10.1200/JCO.22.02887. Epub 2023 Jun 27. PubMed 37369081 ↗
  • 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. PubMed 36041086 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03288545
Lead sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Merck Sharp & Dohme LLC, Seagen Inc.
Responsible party
Sponsor
First posted
Sep 20, 2017
Start date
Oct 11, 2017
Primary completion
Feb 20, 2026
Completion
Feb 20, 2026
Last update
Mar 24, 2026

Study contacts

Changting Meng, MD
study director · Seagen Inc.
Jason Lukas, MD, PhD
study director · Seagen Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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