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BRIEF TITLE: Study of Enfortumab Vedotin in Combination With Pembrolizumab With or Without Chemotherapy, Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer

An Open-label, Randomized, Controlled Phase 3 Study of Enfortumab Vedotin in Combination With Pembrolizumab Versus Chemotherapy Alone in Previously Untreated Locally Advanced or Metastatic Urothelial Cancer


  • Org Study ID: SGN22E-003
  • Secondary ID: 2019-004542-15,MK-3475-A39,KEYNOTE KN-A39
  • NCT ID: NCT04223856
  • NCT Alias:
  • Sponsor: Astellas Pharma Global Development, Inc. - Industry
  • Source: Astellas Pharma Inc

Description

​This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together alone or with platinum chemotherapy to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

Brief Summary

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

Detailed Description


This study is being conducted to evaluate the combination of enfortumab vedotin +
pembrolizumab versus standard of care gemcitabine + platinum-containing chemotherapy, in
subjects with previously untreated locally advanced or metastatic urothelial cancer.

Enfortumab vedotin may be administered for an unlimited number of cycles until a protocol
defined reason for study discontinuation occurs. Pembrolizumab may be administered for a
maximum of 35 cycles or a protocol-defined reason for study discontinuation occurs, whichever
is first. Cisplatin or carboplatin plus gemcitabine may be administered for a maximum of 6
cycles or a protocol-defined reason for study discontinuation occurs, whichever is first.

Overal Status Start Date Phase Study Type
Recruiting March 30, 2020 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Duration of progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent central review (BICR) (Arms A and B only)

Primary Outcome 1 - Time Frame: Up to approximately 5 years

Primary Outcome 2 - Measure: Duration of Overall survival (OS) (Arms and B only)

Primary Outcome 2 - Time Frame: Up to approximately 5 years

Condition:

  • Urothelial Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Histologically documented, unresectable locally advanced or metastatic urothelial
carcinoma

- Measurable disease by investigator assessment according to RECIST v1.1

- Participants with prior definitive radiation therapy must have measurable disease
per RECIST v1.1 that is outside the radiation field or has demonstrated
unequivocal progression since completion of radiation therapy

- Participants must not have received prior systemic therapy for locally advanced or
metastatic urothelial carcinoma with the following exceptions:

- Participants that received neoadjuvant chemotherapy with recurrence >12 months
from completion of therapy are permitted

- Participants that received adjuvant chemotherapy following cystectomy with
recurrence >12 months from completion of therapy are permitted

- Must be considered eligible to receive cisplatin- or carboplatin-containing
chemotherapy, in the investigator's judgment

- Archival tumor tissue comprising muscle-invasive urothelial carcinoma or a biopsy of
metastatic urothelial carcinoma must be provided for PD-L1 testing prior to
randomization

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

- Adequate hematologic and organ function

Exclusion Criteria

- Previously received enfortumab vedotin or other monomethyl auristatin E (MMAE)-based
antibody-drug conjugate (ADCs)

- Received prior treatment with a programmed cell death ligand-1 (PD-(L)-1) inhibitor
for any malignancy, including earlier stage urothelial cancer (UC), defined as a PD-1
inhibitor or PD-L1 inhibitor

- Received prior treatment with an agent directed to another stimulatory or co
inhibitory T-cell receptor

- Received anti-cancer treatment with chemotherapy, biologics, or investigational agents
not otherwise prohibited by exclusion criterion 1-3 that is not completed 4 weeks
prior to first dose of study treatment

- Uncontrolled diabetes

- Estimated life expectancy of less than 12 weeks

- Active central nervous system (CNS) metastases

- Ongoing clinically significant toxicity associated with prior treatment that has not
resolved to ≤ Grade 1 or returned to baseline

- Currently receiving systemic antimicrobial treatment for active infection (viral,
bacterial, or fungal) at the time of randomization. Routine antimicrobial prophylaxis
is permitted.

- Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV)
infection.

- History of another invasive malignancy within 3 years before the first dose of study
drug, or any evidence of residual disease from a previously diagnosed malignancy

- Documented history of a cerebral vascular event (stroke or transient ischemic attack),
unstable angina, myocardial infarction, or cardiac symptoms consistent with New York
Heart Association (NYHA) Class IV within 6 months prior to randomization

- Receipt of radiotherapy within 2 weeks prior to randomization

- Received major surgery (defined as requiring general anesthesia and >24 hour inpatient
hospitalization) within 4 weeks prior to randomization

- Known severe (≥ Grade 3) hypersensitivity to any enfortumab vedotin excipient
contained in the drug formulation of enfortumab vedotin

- Active keratitis or corneal ulcerations

- History of autoimmune disease that has required systemic treatment in the past 2 years

- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced
pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest computed tomography (CT) scan

- Prior allogeneic stem cell or solid organ transplant

- Received a live attenuated vaccine within 30 days prior to randomization
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Christina Derleth, MD, MSCI

Role: Study Director

Affiliation: Seagen Inc.

Overall Contact

Name: Seattle Genetics Trial Information Support

Phone: 866-333-7436

Email: clinicaltrials@seagen.com

Locations

Facility Status Contact
Ironwood Cancer & Research Centers - Chandler
Chandler, Arizona 85224
United States
Completed
Arizona Oncology Associates PD - HOPE
Tucson, Arizona 85710
United States
Completed
Providence St Joseph Medical Center
Burbank, California 91505
United States
Recruiting
City of Hope National Medical Center
Duarte, California 91010
United States
Recruiting
University of California Los Angeles Medical Center
Los Angeles, California 90095
United States
Recruiting
University of California Irvine - Newport
Orange, California 92868
United States
Recruiting
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado 80012
United States
Recruiting
University of Colorado Hospital / University of Colorado
Aurora, Colorado 80045
United States
Recruiting
Cancer Centers of Colorado - Denver
Denver, Colorado 80218
United States
Recruiting
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut 06360
United States
Recruiting
Lombardi Cancer Center / Georgetown University Medical Center
Washington, District of Columbia 20007
United States
Recruiting
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612
United States
Recruiting
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia 30322
United States
Recruiting
Georgia Cancer Specialists / Northside Hospital Cancer Institute
Marietta, Georgia 30060
United States
Completed
Louisiana State University/ East Jefferson General Hospital
Metairie, Louisiana 70006
United States
Recruiting
Maine Health Cancer Care
Biddeford, Maine 04046
United States
Recruiting
Johns Hopkins Medical Center
Baltimore, Maryland 21231
United States
Recruiting
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United States
Recruiting
New Mexico Cancer Center
Albuquerque, New Mexico 87109
United States
Recruiting
New York University (NYU) Cancer Institute
New York, New York 10016
United States
Recruiting
Mount Sinai Medical Center
New York, New York 10029
United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting
Vidant Medical Center
Greenville, North Carolina 27834
United States
Recruiting
The Cleveland Clinic
Cleveland, Ohio 44195
United States
Recruiting
Toledo Clinic Cancer Center
Toledo, Ohio 43623
United States
Completed
Hillman Cancer Center / University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
United States
Completed
Saint Francis Hospital / Bon Secours - South Carolina
Greenville, South Carolina 29607
United States
Completed
West Cancer Center & Research Institute
Germantown, Tennessee 38138
United States
Completed
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Recruiting
UT Health East Texas Hope Cancer Center
Tyler, Texas 75701
United States
Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Recruiting
University of Virginia
Charlottesville, Virginia 22908
United States
Recruiting
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington 98109
United States
Recruiting
Site AUS61001
Douglas, 4814
Australia
Recruiting
Site AUS61004
Heidelberg, 3084
Australia
Recruiting
Site AUS61002
Macquarie Park, 2109
Australia
Recruiting
Site AUS61006
South Australia, 5112
Australia
Recruiting
Site CA11004
Calgary, Alberta T2N 4N2
Canada
Recruiting
Site CA11003
Edmonton, Alberta T6G 1Z2
Canada
Recruiting
Site CA11006
Vancouver, British Columbia V5Z 4E6
Canada
Recruiting
Site CA11002
Hamilton, Ontario L8V 1C3
Canada
Recruiting
Site CA11009
London, Ontario N6A 5A5
Canada
Recruiting
Site CA11011
Oshawa, Ontario L1G 2B9
Canada
Recruiting
Site CA11005
Toronto, Ontario M5G 2M9
Canada
Recruiting
Site CA11010
Montreal, Quebec H2X 0A9
Canada
Recruiting
Site CA11001
Montreal, Quebec H3T 1E2
Canada
Recruiting
Site CA11008
Quebec, G1R 2J6
Canada
Recruiting
Site FR33016
Lyon, 69373
France
Recruiting
Site KR82001
Daejeon, 301-721
Korea, Republic of
Recruiting
Site KR82002
Goyang-si, 10408
Korea, Republic of
Recruiting
Site SK82008
Hwasun, 519-763
Korea, Republic of
Recruiting
Site KR82004
Seongnam-si, 13605
Korea, Republic of
Recruiting
Site KR82003
Seoul, 03722
Korea, Republic of
Recruiting
Site KR82007
Seoul, 135-710
Korea, Republic of
Recruiting
Site RU70006
Leningradskaya Oblast', 188663
Russian Federation
Recruiting
Site RU70002
Omsk, 644013
Russian Federation
Recruiting
Site RU70010
Saint Petersburg, 195271
Russian Federation
Recruiting
Site RU70007
Saint Petersburg, 197082
Russian Federation
Recruiting
Site RU70005
Ufa, 450000
Russian Federation
Recruiting
Site SP34017
Barcelona, 08003
Spain
Recruiting
Site ES34010
Barcelona, 08035
Spain
Recruiting
Site SP34001
Barcelona, 08041
Spain
Recruiting
Site ES34013
Cordoba, 14004
Spain
Recruiting
Site ES34002
Madrid, 28034
Spain
Recruiting
Site ES34004
Manresa, 08243
Spain
Recruiting
Site ES34020
Pamplona, 31008
Spain
Recruiting
Site SP34016
Sabadell, 08208
Spain
Recruiting
Site SP34012
Santander, 39008
Spain
Recruiting
Site ES34007
Sevilla, 41013
Spain
Recruiting
Site CH41002
Bern, 3010
Switzerland
Recruiting
Site CH41001
Chur, 7000
Switzerland
Recruiting
Site CH41003
Winterthur, 8401
Switzerland
Recruiting
Site TW88607
Taichung, 40447
Taiwan
Recruiting
Site TW88604
Tainan, 70403
Taiwan
Recruiting
Site TW88605
Taipei, 10002
Taiwan
Recruiting
Site TW88601
Taipei, 11217
Taiwan
Recruiting