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A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer (EV-103)

Primary Purpose

Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Urologic Neoplasms

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
enfortumab vedotin (EV)
pembrolizumab
cisplatin
carboplatin
gemcitabine
Sponsored by
Astellas Pharma Global Development, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Transitional Cell focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Alaska Urological Institute
  • Banner MD Anderson Cancer Center
  • Mayo Clinic Arizona
  • Arizona Oncology Associates, PC - HOPE
  • Highlands Oncology Group
  • Tower Hematology Oncology Medical Group
  • UC San Diego / Moores Cancer Center
  • University of California Irvine - Newport
  • University of California, Davis Comprehensive Cancer Center
  • University of California at San Francisco
  • Saint Joseph Heritage Medical Group
  • Stanford Cancer Center / Blood & Marrow Transplant Program
  • Kaiser Permanente Southern California
  • Rocky Mountain Cancer Centers - Aurora
  • University of Colorado Hospital / University of Colorado
  • Yale Cancer Center
  • Eastern CT Hematology and Oncology Associates
  • Georgetown University Medical Center
  • Boca Raton Regional Hospital / Lynn Cancer Institute
  • Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
  • Mayo Clinic Florida
  • University of Miami
  • Piedmont Cancer Institute
  • Winship Cancer Institute / Emory University School of Medicine
  • University of Chicago Medical Center
  • Decatur Memorial Hospital - Illinois
  • Northwestern Medicine Cancer Center - Kishwaukee / Kishwaukee Cancer Center
  • Northwestern Medicine Cancer Center Delnor
  • Cardinal Bernardin Cancer Center / Loyola University Medical Center
  • Northwestern Medicine Cancer Center - Warrenville / Central DuPage Hospital - Cancer Care
  • University of Kansas Cancer Center
  • Tulane University Hospital and Clinic
  • Ochsner Clinic Foundation
  • Maryland Oncology Hematology, P.A.
  • Southcoast Centers for Cancer Care - Fairhaven Site
  • University of Michigan Comprehensive Cancer Center
  • Henry Ford Health System
  • McLaren Greater Lansing Hospital
  • University of Minnesota
  • University of Mississippi Medical Center
  • Washington University School of Medicine - Siteman Cancer Center
  • Nebraska Hematology Oncology P.C.
  • OptumCare Cancer Center
  • Memorial Sloan Kettering Cancer Center - Basking Ridge
  • Hackensack University Medical Center
  • Memorial Sloan Kettering Cancer Center - Monmouth
  • Memorial Sloan Kettering Cancer Center - Bergen
  • University of New Mexico Cancer Center
  • New York Oncology Hematology, P.C.
  • Roswell Park Cancer Institute
  • Memorial Sloan Kettering Cancer Center - Commack
  • Memorial Sloan Kettering Cancer Center - Westchester
  • Northwell Cancer Center / Monter Cancer Center
  • NYU Winthrop Hospital
  • New York University (NYU) Cancer Institute
  • Weill Cornell Medical College
  • Memorial Sloan Kettering Cancer Center
  • University of Rochester Medical Center
  • Memorial Sloan Kettering Cancer Center - Nassau
  • UNC Lineberger Comprehensive Cancer Center / University of North Carolina
  • Levine Cancer Institute
  • Duke University Medical Center
  • Vidant Medical Center
  • Gabrail Cancer Center Research, LLC
  • Case Western Reserve University / University Hospitals Case Medical Center
  • Toledo Clinic Cancer Center
  • CMOH Broomall
  • Penn State Milton S. Hershey Medical Center
  • Fox Chase Cancer Center
  • Allegheny General Hospital
  • Medical University of South Carolina/Hollings Cancer Center
  • Saint Francis Hospital Cancer Center
  • Carolina Urologic Research Center
  • Sarah Cannon Research Institute
  • Tennessee Oncology / Sarah Cannon Research Institute
  • Texas Oncology - Fort Worth Cancer Center
  • University of Texas Health Science Center at San Antonio
  • Texas Oncology - Tyler
  • Utah Cancer Specialists
  • University of Virginia
  • Virginia Oncology Associates - Norfolk
  • Medical Oncology Associates
  • Medical College of Wisconsin (Milwaukee)
  • Site CA11008
  • Site CA11011
  • Site CA11001
  • Site CA11005
  • Site CA11013
  • Site CA11002
  • Site FR33008
  • Site FR33005
  • Site FR33003
  • Site FR33004
  • Site FR33010
  • Site FR33002
  • Site FR33006
  • Site FR33001
  • Site IT39002
  • Site PR78701
  • Site ES34006
  • Site ES34008
  • Site ES34001
  • Site ES34012
  • Site ES34007
  • Site ES34005
  • Site ES34004

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

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

Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2L

Cohort D: Enfortumab Vedotin + Cisplatin in 1L

Cohort E: Enfortumab Vedotin + Carboplatin in 1L

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

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

Cohort H: Enfortumab vedotin in MIBC neoadjuvant setting

Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant setting

Randomized Cohort K: Enfortumab Vedotin Monotherapy

Randomized Cohort K: Enfortumab Vedotin + Pembrolizumab

Cohort L: Enfortumab vedotin in MIBC in perioperative setting

Arm Description

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

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

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

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

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

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

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

Enfortumab vedotin on days 1 and 8 every 21 days

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

Enfortumab vedotin on days 1 and 8 every 21 days

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

Enfortumab vedotin on days 1 and 8 and every 21 days

Outcomes

Primary Outcome Measures

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.
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.
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
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.

Secondary Outcome Measures

Incidence of dose-limiting toxicity (DLT)
Incidence of DLTs (dose-escalation expansion Cohorts D, E, F, and the first 6 patients of Cohort G).
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.
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
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.
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.
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
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.
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.
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
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.
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.
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
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.
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.
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.
Overall survival (OS) (all cohorts)
The time from start of study treatment to date of death due to any cause.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
DFS by BICR (Cohort L only)
DFS is defined as the time from RC to the time of first occurrence of a DFS event
Type, incidence, severity, seriousness, and relatedness of AEs (Randomized Cohort K and MIBC cohorts only)
Descriptive statistics will be used to summarize results.
Type, incidence, and severity of laboratory abnormalities (Randomized Cohort K and MIBC cohorts only)
Descriptive statistics will be used to summarize results.
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.

Full Information

First Posted
September 18, 2017
Last Updated
October 17, 2023
Sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Merck Sharp & Dohme LLC, Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03288545
Brief Title
A Study of Enfortumab Vedotin Alone or With Other Therapies for Treatment of Urothelial Cancer
Acronym
EV-103
Official Title
A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Merck Sharp & Dohme LLC, Seagen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
multi-cohort, open-label, multicenter study, global
Masking
None (Open Label)
Allocation
Randomized
Enrollment
348 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EV + Pembrolizumab in cisplatin-ineligible 1L and in 2L
Arm Type
Experimental
Arm Description
Dose Escalation: Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Arm Title
Cohort A: EV + Pembrolizumab in cisplatin-ineligible 1L
Arm Type
Experimental
Arm Description
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Arm Title
Optional Cohort B: Enfortumab Vedotin + Pembrolizumab in 2L
Arm Type
Experimental
Arm Description
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Arm Title
Cohort D: Enfortumab Vedotin + Cisplatin in 1L
Arm Type
Experimental
Arm Description
Enfortumab vedotin on days 1 and 8 plus cisplatin on day 1 every 21 days
Arm Title
Cohort E: Enfortumab Vedotin + Carboplatin in 1L
Arm Type
Experimental
Arm Description
Enfortumab vedotin on days 1 and 8 plus carboplatin on day 1 every 21 days
Arm Title
Optional Cohort F: Enfortumab Vedotin+Gemcitabine in 1L and 2L
Arm Type
Experimental
Arm Description
Enfortumab vedotin and gemcitabine on days 1 and 8 every 21 days
Arm Title
Cohort G: Enfortumab Vedotin + Platinum + Pembrolizumab in 1L
Arm Type
Experimental
Arm Description
Enfortumab vedotin on days 1 and 8 plus cisplatin or carboplatin on day 1 plus pembrolizumab on day 1 every 21 days
Arm Title
Cohort H: Enfortumab vedotin in MIBC neoadjuvant setting
Arm Type
Experimental
Arm Description
Enfortumab vedotin on days 1 and 8 every 21 days
Arm Title
Optional Cohort J:EV+Pembrolizumab in MIBC neoadjuvant setting
Arm Type
Experimental
Arm Description
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Arm Title
Randomized Cohort K: Enfortumab Vedotin Monotherapy
Arm Type
Experimental
Arm Description
Enfortumab vedotin on days 1 and 8 every 21 days
Arm Title
Randomized Cohort K: Enfortumab Vedotin + Pembrolizumab
Arm Type
Experimental
Arm Description
Enfortumab vedotin on days 1 and 8 plus pembrolizumab on day 1 every 21 days
Arm Title
Cohort L: Enfortumab vedotin in MIBC in perioperative setting
Arm Type
Experimental
Arm Description
Enfortumab vedotin on days 1 and 8 and every 21 days
Intervention Type
Drug
Intervention Name(s)
enfortumab vedotin (EV)
Other Intervention Name(s)
ASG-22CE, ASG-22ME, PADCEV
Intervention Description
Intravenous (IV) infusion on days 1 and 8 every 21 days
Intervention Type
Drug
Intervention Name(s)
pembrolizumab
Other Intervention Name(s)
Keytruda
Intervention Description
IV infusion on day 1 every 21 days
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
IV infusion on day 1 every 21 days
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
IV infusion on day 1 every 21 days
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
IV infusion on days 1 and 8 every 21 days
Primary Outcome Measure Information:
Title
Type, incidence, severity, seriousness, and relatedness of adverse events (Dose escalation and Expansion Parts 1 to 3 cohorts only)
Description
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.
Title
Type, incidence, and severity of laboratory abnormalities (Dose escalation and Expansion Parts 1 to 3 cohorts only)
Description
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.
Title
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)
Description
The proportion of patients with confirmed complete response (CR) or partial response (PR) according to RECIST 1.1
Time Frame
Up to 3 years
Title
Pathological complete response (pCR) rate per central pathology review (MIBC cohorts only)
Description
The proportion of patients with absence of viable tumor tissue at the time of radical cystectomy.
Time Frame
Up to approximately 5 months
Secondary Outcome Measure Information:
Title
Incidence of dose-limiting toxicity (DLT)
Description
Incidence of DLTs (dose-escalation expansion Cohorts D, E, F, and the first 6 patients of Cohort G).
Time Frame
21 days
Title
Confirmed ORR by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
Description
The proportion of patients with confirmed CR or PR according to RECIST 1.1.
Time Frame
Up to 3 years
Title
Confirmed ORR by BICR according to RECIST 1.1 (Dose escalation and Cohort A only)
Description
The proportion of patients with confirmed CR or PR according to RECIST 1.1
Time Frame
Up to 3 years
Title
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)
Description
The proportion of patients with confirmed CR or PR according to iRECIST.
Time Frame
Up to 3 years
Title
Disease control rate (DCR) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
Description
Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1.
Time Frame
Up to 5 years
Title
DCR by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only)
Description
Proportion of patients with CR, PR, or stable disease (SD) according to RECIST 1.1
Time Frame
Up to 3 years
Title
DCR by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts using pembrolizumab only)
Description
Proportion of patients with CR, PR, or SD according to iRECIST.
Time Frame
Up to 3 years
Title
Duration of response (DOR) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
Description
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
Title
DOR by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only)
Description
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
Title
DOR by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts with pembrolizumab only)
Description
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
Title
Progression free survival on study therapy (PFS) by investigator assessment according to RECIST 1.1 (la/mUC cohorts only)
Description
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
Title
PFS by BICR according to RECIST 1.1 (Dose escalation, Cohort A, and randomized Cohort K only)
Description
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
Title
PFS by investigator assessment according to iRECIST (Dose escalation and Part 1-3 cohorts with pembrolizumab only)
Description
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
Title
Event-free (EFS) on study therapy by BICR (Cohort L only)
Description
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
Title
Event-free (EFS) on study therapy by investigator assessment (MIBC cohorts only)
Description
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
Title
Overall survival (OS) (all cohorts)
Description
The time from start of study treatment to date of death due to any cause.
Time Frame
Up to 5 years
Title
Pharmacokinetics (PK) parameter for enfortumab vedotin: Maximum concentration (Cmax) (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Description
Cmax will be derived from the PK blood samples collected.
Time Frame
Through 2 cycles of treatment, up to 42 days
Title
PK parameter for monomethyl auristatin E (MMAE): Cmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Description
Cmax will be derived from the PK blood samples collected.
Time Frame
Through 2 cycles of treatment, up to 42 days
Title
PK parameter for total antibody (Tab): Cmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Description
Cmax will be derived from the PK blood samples collected.
Time Frame
Through 2 cycles of treatment, up to 42 days
Title
Incidence of antitherapeutic antibodies (ATA) to enfortumab vedotin (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Description
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.
Title
PK parameter for enfortumab vedotin: Time to maximum concentration (Tmax) (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Description
Tmax will be derived from the PK blood samples collected.
Time Frame
Through 2 cycles of treatment, up to 42 days
Title
PK parameter for MMAE: Tmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Description
Tmax will be derived from the PK blood samples collected.
Time Frame
Through 2 cycles of treatment, up to 42 days
Title
PK parameter for Tab: Tmax (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Description
Tmax will be derived from the PK blood samples collected.
Time Frame
Through 2 cycles of treatment, up to 42 days
Title
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)
Description
AUC will be derived from the PK blood samples collected.
Time Frame
Through 2 cycles of treatment, up to 42 days
Title
PK parameter for MMAE: AUC (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Description
AUC will be derived from the PK blood samples collected.
Time Frame
Through 2 cycles of treatment, up to 42 days
Title
PK parameter for Tab: AUC (Dose escalation and Expansion Parts 1 to 3; non-randomized la/mUC cohorts only)
Description
AUC will be derived from the PK blood samples collected.
Time Frame
Through 2 cycles of treatment, up to 42 days
Title
Pathologic downstaging (pDS) rate by central pathology review (MIBC cohorts only)
Description
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
Title
Disease-free survival (DFS) by investigator assessment (MIBC cohorts only)
Description
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
Title
DFS by BICR (Cohort L only)
Description
DFS is defined as the time from RC to the time of first occurrence of a DFS event
Time Frame
Up to 3 years
Title
Type, incidence, severity, seriousness, and relatedness of AEs (Randomized Cohort K and MIBC cohorts only)
Description
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
Title
Type, incidence, and severity of laboratory abnormalities (Randomized Cohort K and MIBC cohorts only)
Description
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
Title
Percentage of planned radical cystectomy and pelvic lymph node dissections (RC+PLND) delayed due to treatment-related AEs (MIBC cohorts only)
Description
Delayed is defined as greater than 12 weeks after the last dose of treatment.
Time Frame
Up to approximately 5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changting Meng, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jason Lukas, MD, PhD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Urological Institute
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Facility Name
Banner MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Arizona Oncology Associates, PC - HOPE
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Tower Hematology Oncology Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
UC San Diego / Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California Irvine - Newport
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California, Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94134
Country
United States
Facility Name
Saint Joseph Heritage Medical Group
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Stanford Cancer Center / Blood & Marrow Transplant Program
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Kaiser Permanente Southern California
City
Woodland Hills
State/Province
California
ZIP/Postal Code
91367
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
University of Colorado Hospital / University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045-0510
Country
United States
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Eastern CT Hematology and Oncology Associates
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Boca Raton Regional Hospital / Lynn Cancer Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Piedmont Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Winship Cancer Institute / Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Decatur Memorial Hospital - Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Northwestern Medicine Cancer Center - Kishwaukee / Kishwaukee Cancer Center
City
DeKalb
State/Province
Illinois
ZIP/Postal Code
60115
Country
United States
Facility Name
Northwestern Medicine Cancer Center Delnor
City
Geneva
State/Province
Illinois
ZIP/Postal Code
60134
Country
United States
Facility Name
Cardinal Bernardin Cancer Center / Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Northwestern Medicine Cancer Center - Warrenville / Central DuPage Hospital - Cancer Care
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Maryland Oncology Hematology, P.A.
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Facility Name
Southcoast Centers for Cancer Care - Fairhaven Site
City
Fairhaven
State/Province
Massachusetts
ZIP/Postal Code
02719
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
McLaren Greater Lansing Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39213
Country
United States
Facility Name
Washington University School of Medicine - Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Hematology Oncology P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
OptumCare Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Northwell Cancer Center / Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
New York University (NYU) Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10087-9049
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Gabrail Cancer Center Research, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Case Western Reserve University / University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Toledo Clinic Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
CMOH Broomall
City
Broomall
State/Province
Pennsylvania
ZIP/Postal Code
19008
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Medical University of South Carolina/Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Saint Francis Hospital Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology / Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology - Fort Worth Cancer Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia Oncology Associates - Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Medical Oncology Associates
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Medical College of Wisconsin (Milwaukee)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Site CA11008
City
East Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
Site CA11011
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Site CA11001
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Site CA11005
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada
Facility Name
Site CA11013
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
Facility Name
Site CA11002
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Site FR33008
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Site FR33005
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Site FR33003
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Site FR33004
City
Marseilles
ZIP/Postal Code
13273
Country
France
Facility Name
Site FR33010
City
Moselle
ZIP/Postal Code
54519
Country
France
Facility Name
Site FR33002
City
Nice Cedex
ZIP/Postal Code
06189
Country
France
Facility Name
Site FR33006
City
Pierre-Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Site FR33001
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Site IT39002
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Site PR78701
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Site ES34006
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Site ES34008
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Site ES34001
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Site ES34012
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Site ES34007
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Site ES34005
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Site ES34004
City
Santander
ZIP/Postal Code
39008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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