A Study of Enfortumab Vedotin Plus Pembrolizumab and/or Chemotherapy for Patients With Urothelial Bladder Cancer (EV-103)



Status:Recruiting
Conditions:Prostate Cancer, Prostate Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/22/2018
Start Date:October 11, 2017
End Date:September 2024
Contact:Seattle Genetics Trial Information Support
Email:clinicaltrials@seagen.com
Phone:866-333-7436

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A Dose-escalation and Dose-expansion Study of Enfortumab Vedotin (ASG-22CE) in Combination With Pembrolizumab and/or Chemotherapy for Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer

This study will test an experimental drug (enfortumab vedotin) with different combinations of
pembrolizumab and/or chemotherapy. 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 that has spread to
nearby tissues or to other areas of the body. This study will have different parts to look at
the side effects of (1) enfortumab vedotin with pembrolizumab, (2) enfortumab vedotin with
chemotherapy, and (3) enfortumab vedotin with pembrolizumab and chemotherapy. 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.

This study will examine the safety and anticancer activity of enfortumab vedotin given
intravenously in combination with pembrolizumab and/or chemotherapy to patients with locally
advanced or metastatic urothelial cancer. The primary goal of the study is to determine the
safety and tolerability of enfortumab vedotin in combination with pembrolizumab and/or
chemotherapy. The study will be conducted in multiple parts: dose escalation (enfortumab
vedotin + pembrolizumab) and dose expansion (cohorts of enfortumab vedotin + pembrolizumab
and/or chemotherapy).

Inclusion Criteria:

- Histologically documented locally advanced or metastatic urothelial carcinoma
(la/mUC), including squamous differentiation or mixed cell types.

- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2.

- Eligible for pembrolizumab (Dose-escalation cohorts, Cohorts A, B, and G)

- 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.

Exclusion Criteria:

- 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
We found this trial at
18
sites
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Aurora, CO
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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mi
from
Buffalo, NY
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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from
Atlanta, GA
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Chapel Hill, NC
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Charleston, SC
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Charlotte, North Carolina 28211
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Charlotte, NC
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from
Cleveland, OH
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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2160 S. First Ave.
Maywood, Illinois 60153
888-584-7888
Cardinal Bernardin Cancer Center at Loyola University Medical Center The Cardinal Bernardin Cancer Center is...
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mi
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Maywood, IL
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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New York, New York 10021
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from
New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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San Francisco, California 94143
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San Francisco, CA
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Stanford, CA
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Westwood, Kansas 66205
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Westwood, KS
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