Bladder Cancer Clinical Trial

A Study of Disitamab Vedotin Alone and 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:

Expected survival ≥12 weeks
Histologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra

Cohorts A and B: Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy

Neoadjuvant or adjuvant systemic therapy, with progression within 12 months of completing last dose of therapy, is considered a line of prior therapy.
Maintenance avelumab therapy delivered following first-line platinum therapy is not considered a separate line of therapy.
Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second-line treatment is allowed

Cohort C: No prior systemic therapy for LA/mUC

Neoadjuvant or adjuvant therapy, including PD-(L1) inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy
Cohorts A and B only: Radiographically documented disease progression during or after the most recent line of therapy for LA/mUC
At least one measurable lesion by investigator assessment based on RECIST version 1.1.
Cohort C only: Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation
Participants must be able to provide archived tumor tissue prior to treatment initiation. If archival tissue is not available, a baseline biopsy is required within 28 days of Cycle 1 Day 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:

Cohorts A and B: ECOG of 0 or 1
Cohort C: ECOG of 0, 1, or 2

Exclusion Criteria:

Known hypersensitivity to disitamab vedotin, pembrolizumab (in Cohort C), or any of their components
Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study
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

Other malignant tumors within 3 years of study treatment, except for:

Prostate cancer treated with definitive intent (surgically or with radiation therapy) ≥ 1 year prior to treatment initiation is acceptable
Malignancies that can be cured after treatment

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:

270

Study ID:

NCT04879329

Recruitment Status:

Recruiting

Sponsor:

Seagen Inc.

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There are 11 Locations for this study

See Locations Near You

UCLA Medical Center / David Geffen School of Medicine
Los Angeles California, 90095, United States More Info
Alexandra Drakaki
Principal Investigator
University of Colorado Health Memorial Hospital
Colorado Springs Colorado, 80909, United States More Info
Rubens Chang
Principal Investigator
Northwest Georgia Oncology Centers, P.C.
Marietta Georgia, 30060, United States More Info
Steve McCune
Principal Investigator
Karmanos Cancer Institute / Wayne State University
Detroit Michigan, 48226, United States More Info
Elisabeth Heath
Principal Investigator
Cancer and Hematology Centers of Western Michigan / Spectrum Health Butterworth Campus
Grand Rapids Michigan, 49503, United States More Info
Eric Batts
Principal Investigator
Mount Sinai - Tisch Cancer Institute
New York New York, 10029, United States More Info
Matthew Galsky
Principal Investigator
SUNY Upstate Medical Universit
Syracuse New York, 13210, United States More Info
Alina Basnet
Principal Investigator
Levine Cancer Institute
Charlotte North Carolina, 90404, United States More Info
Earle Burgess
Principal Investigator
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States More Info
Jason Brown, MD
Principal Investigator
University of Tennessee
Knoxville Tennessee, 37920, United States More Info
Saikrishna Gadde
Principal Investigator
Inova Health Care Services
Falls Church Virginia, 22042, United States More Info
Jeanny Aragon-Ching
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

270

Study ID:

NCT04879329

Recruitment Status:

Recruiting

Sponsor:


Seagen Inc.

How clear is this clinincal trial information?

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