Bladder Cancer Clinical Trial

A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

Summary

This study is being done to see if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat HER2 expressing urothelial cancer. It will also test how safe the drug is for participants.

Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).

It will also study what side effects happen when participants get the drug. A side effect is anything a drug does to your body besides treating the disease.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Cohorts A and B

Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra
Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy
At least one measurable lesion by investigator assessment based on RECIST version 1.1.
HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Cohort C

Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra

No prior systemic therapy for LA/mUC

Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy
At least one measurable lesion by investigator assessment based on RECIST v1.1.
Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample
ECOG performance status of 0, 1, or 2

Cohort D

Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra

Based on a participant's eligibility to receive treatment with standard of care therapies in Japan, participants must have received all of the following lines of therapy for LA/mUC:

a. One prior line of platinum-containing chemotherapy.
b. Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second line treatment.
c. Prior enfortumab vedotin therapy.
At least one measurable lesion by investigator assessment based on RECIST v1.1.
ECOG performance status of 0 or 1

Cohort E

Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra

No prior systemic therapy for LA/mUC

Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy.
At least one measurable lesion by investigator assessment based on RECIST v1.1.
Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample
ECOG performance status of 0 or 1

Exclusion Criteria:

Cohorts A and B

Known hypersensitivity to disitamab vedotin or any of their components
Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohorts A and B)
Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
Major surgery that has not fully recovered within 4 weeks prior to dose administration
Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline

Cohort C

Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components
Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study defined as Cycle 1 Day 1 for the single-arm part of Cohort C and as randomization date for the randomized part of Cohort C)
Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
Major surgery that has not fully recovered within 4 weeks prior to dose administration
Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
Participants who have previously received any prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists) are excluded.

Cohort D

Known hypersensitivity to disitamab vedotin or any of their components
Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort D)
Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy
Major surgery that has not fully recovered within 4 weeks prior to dose administration
Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline

Cohort E

Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components
Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort E)
Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy
Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy
Major surgery that has not fully recovered within 4 weeks prior to dose administration
Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

332

Study ID:

NCT04879329

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 53 Locations for this study

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Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States More Info
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Isaac Bowman
Principal Investigator
City of Hope
Duarte California, 91010, United States More Info
Abhishek Tripathi
Principal Investigator
University of California Los Angeles Medical Center
Los Angeles California, 90095, United States More Info
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Alexandra Drakaki
Principal Investigator
University of California Irvine Medical Center
Orange California, 92868, United States More Info
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Nataliya Mar
Principal Investigator
Kaiser Permanente Southern California
Riverside California, 92505, United States More Info
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Helen Moon
Principal Investigator
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco California, 94158, United States More Info
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Vadim Koshkin
Principal Investigator
University of Colorado Health Memorial Hospital
Colorado Springs Colorado, 80909, United States More Info
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Rubens C Chang
Principal Investigator
Florida Cancer Specialists - South Region
Fort Myers Florida, 33901, United States More Info
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Amir Harandi
Principal Investigator
Florida Cancer Specialists - Panhandle
Tallahassee Florida, 32308, United States More Info
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Pareshkumar Patel
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States More Info
Seagen Trial Information Support
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Rohit Jain
Principal Investigator
Florida Cancer Specialists - East West Palm Beach, FL (SCRI)
West Palm Beach Florida, 33401, United States More Info
Seagen Trial Information Support
Contact
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Barry Berman
Principal Investigator
Northwest Georgia Oncology Centers, P.C.
Marietta Georgia, 30060, United States More Info
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Steve McCune
Principal Investigator
University of Chicago Medical Center
Chicago Illinois, 60637, United States More Info
Seagen Trial Information Support
Contact
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Peter H O'Donnell
Principal Investigator
Karmanos Cancer Institute / Wayne State University
Detroit Michigan, 48226, United States More Info
Seagen Trial Information Support
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Elisabeth Heath
Principal Investigator
Cancer and Hematology Centers of Western Michigan / Spectrum Health Butterworth Campus
Grand Rapids Michigan, 49503, United States More Info
Seagen Trial Information Support
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Eric Batts, MD
Principal Investigator
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States More Info
Seagen Trial Information Support
Contact
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Oscar B Goodman Jr.
Principal Investigator
Mount Sinai Medical Center
New York New York, 10029, United States More Info
Seagen Trial Information Support
Contact
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Matthew Galsky
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
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Gopakumar Iyer
Principal Investigator
SUNY Upstate Medical University
Syracuse New York, 13210, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Seagen Trial Information Support
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Earle Burgess
Principal Investigator
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States More Info
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Jason Robert Brown
Principal Investigator
Oregon Health and Science University
Portland Oregon, 97239, United States More Info
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Christopher Ryan
Principal Investigator
University of Tennessee
Knoxville Tennessee, 37920, United States More Info
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Saikrishna Gadde
Principal Investigator
MD Anderson Cancer Center / University of Texas
Houston Texas, 77030, United States More Info
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Matthew T Campbell
Principal Investigator
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States More Info
Seagen Trial Information Support
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Jeanny B Aragon-Ching, MD, F.A.C.P.
Principal Investigator
Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington
Seattle Washington, 98109, United States More Info
Seagen Trial Information Support
Contact
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Evan Yu
Principal Investigator
Medical College of Wisconsin (Milwaukee)
Milwaukee Wisconsin, 53226, United States More Info
Ariel Nelson
Principal Investigator
Centro de Oncologia e Investigacion de Buenos Aires (COIBA)
Berazategui Other, B1884, Argentina More Info
Mirta Varela
Principal Investigator
Hospital Aleman (HA) Deutsches Hospital
Buenos Aires Other, 1118, Argentina More Info
Gabriela Gatica
Principal Investigator
Hospital Sirio Libanes
Caba Other, 1425, Argentina More Info
Hernan Cutuli
Principal Investigator
Instituto Alexander Fleming
Ciudad Autonoma Buenos Aires Other, C1426, Argentina More Info
Juan Pablo Sade
Principal Investigator
Peninsula and South East Oncology
Frankston Other, 3199, Australia More Info
Sanjeev Sewak
Principal Investigator
Mater Cancer Care Centre
South Brisbane Other, 4101, Australia More Info
Niara Oliveira
Principal Investigator
Royal North Shore Hospital
St Leonards Other, 2065, Australia More Info
Laurence Krieger, MD
Principal Investigator
British Columbia Cancer Agency - Vancouver Centre
Vancouver British Columbia, V5Z4E, Canada More Info
Bernhard Eigl
Principal Investigator
Jewish General Hospital
Montreal Quebec, H3T 1, Canada More Info
April Rose, MD, PhD
Principal Investigator
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke Quebec, J1H 5, Canada More Info
Michel Pavic
Principal Investigator
Pontificia Universidad Catolica De Chile Santiago
Santiago Other, 77701, Chile More Info
Carolina Ibanez
Principal Investigator
Instituto Oncologico Fundacion Arturo Lopez Perez (FALP)
Santiago Other, Provi, Chile More Info
Pamela Salman
Principal Investigator
Rambam Health Corp.
Haifa Other, 31096, Israel More Info
Avivit Pe'er
Principal Investigator
Rabin Medical Center
Petach Tikva Other, 49414, Israel
Sheba Medical Center
Ramat Gan Other, 52621, Israel More Info
Michal Sarfaty
Principal Investigator
Tel Aviv Sourasky Medical Center
Tel Aviv Other, 64239, Israel More Info
David Sarid
Principal Investigator
National Cancer Center Hospital East
Kashiwa-shi Other, 277-8, Japan More Info
Nobuaki Matsubara
Principal Investigator
Osaka International Cancer Institute
Osaka Other, 541-8, Japan More Info
Masashi Nakayama
Principal Investigator
Sapporo Medical University Hospital
Sapporo Other, 060-8, Japan More Info
Naoya Masumori
Principal Investigator
Osaka University Hospital
Suita-shi Other, 565-0, Japan More Info
Atsunari Kawashima
Principal Investigator
Tokushima University Hospital
Tokushima Other, 770-8, Japan More Info
Masayuki Takahashi
Principal Investigator
The Cancer Institute Hospital of JFCR
Tokyo Other, 135-8, Japan More Info
Takeshi Yuasa
Principal Investigator
The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington Other, CH63 , United Kingdom More Info
Joachim Chan
Principal Investigator
Cambridge University Hospitals NHS Foundation Trust
Cambridge Other, CB2 0, United Kingdom More Info
Danish Mazhar
Principal Investigator
NHS Greater Glasgow and Clyde (NHSGGC) - The Beatson West of Scotland Cancer Centre
Glasgow Other, G12 0, United Kingdom More Info
Robert Jones
Principal Investigator
Barts Health NHS Trust Saint Bartholomews Hospital
London Other, EC1A , United Kingdom More Info
Thomas Powles
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

332

Study ID:

NCT04879329

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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