Recruiting
Phase 2

Disitamab Vedotin & Pembrolizumab

Sponsor:

Seagen, a wholly owned subsidiary of Pfizer

Code:

NCT04879329

Conditions

Urothelial Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

disitamab vedotin

pembrolizumab

Study Details

Brief 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.

Conditions

Urothelial Carcinoma

Study ID

NCT04879329

Start date

May 3, 2022

Status verified date

Jul, 2026

Completion date

Apr 14, 2029

Anticipated

Primary completion date

Dec 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Cohort G

  • 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 therapy containing enfortumab vedotin as monotherapy or in combination with pembrolizumab

  • The last administration of enfortumab vedotin must be 90 days from the start of study treatment. Intervening therapies are allowed between the final dose of enfortumab vedotin and the start of disitamab vedotin.
  • 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

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)
  • Prior HER2-directed therapy
  • 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

Cohort G

  • 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 G)
  • Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)
  • Prior 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

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

Study Design

Enrollment

372 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A - DV monotherapy for HER2-positive tumor types

Disitamab vedotin monotherapy

experimental: Cohort B - DV monotherapy for HER2-low tumor types

Disitamab vedotin monotherapy

experimental: Cohort C - Non-randomized combination therapy

Disitamab vedotin + pembrolizumab

experimental: Cohort C - Randomized combination therapy

Disitamab vedotin + pembrolizumab

experimental: Cohort C - Randomized monotherapy

Disitamab vedotin monotherapy

experimental: Cohort D - DV monotherapy (Japan only)

Disitamab vedotin monotherapy

experimental: Cohort E - DV combination therapy (Japan only)

Disitamab vedotin + pembrolizumab

experimental: Cohort G - DV monotherapy

Disitamab vedotin

Interventions

disitamab vedotin

Given into the vein (IV; intravenous) every 2 weeks.

pembrolizumab

Given by IV on Day 1 of each 6-week cycle.

Primary outcome measure

  • Confirmed Objective Response Rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) by blinded independent central review (BICR) (Cohorts A, B, C, and G) [ Time Frame: Duration of treatment; approximately 2 years ]
  • Incidence of adverse events (AEs) (Cohorts D and E) [ Time Frame: Approximately 2 years ]
  • Incidence of dose alterations (Cohorts D and E) [ Time Frame: Approximately 2 years ]
  • Incidence of laboratory abnormalities (Cohorts D and E) [ Time Frame: Approximately 2 years ]
  • Incidence of electrocardiogram (ECG) abnormalities (Cohorts D and E) [ Time Frame: Approximately 2 years ]
  • Change from baseline of left ventricular ejection fraction (LVEF) (Cohorts D and E) [ Time Frame: Approximately 2 years ]
  • Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Cohorts D and E) [ Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years ]
  • PK parameter - Maximum concentration (Cmax) (Cohorts D and E) [ Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years ]
  • PK parameter - Time to maximum concentration (Tmax) (Cohorts D and E) [ Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years ]
  • PK parameter - Trough concentration (Ctrough) (Cohorts D and E) [ Time Frame: Through 30-37 days following the last dose of DV; up to approximately 2 years ]

Central Contacts and Locations

Central contacts

Locations

Banner Gateway Medical Center

Recruiting

Gilbert, Arizona, United States, 85234

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Kaiser Permanente Anaheim Kraemer Medical Offices

Recruiting

Anaheim, California, United States, 92806

Foothill Cardioology

Recruiting

Arcadia, California, United States, 91007

Kaiser Permanente Baldwin Park Medical Center

Recruiting

Baldwin Park, California, United States, 91706

Kaiser Permanente Bellflower Medical Offices

Recruiting

Bellflower, California, United States, 90706

Beverly Hills Multi-Specialties Practice

Recruiting

Beverly Hills, California, United States, 90211

Providence Saint Joseph Medical Center

Recruiting

Burbank, California, United States, 91505

UCLA Burbank Cardiology

Recruiting

Burbank, California, United States, 91505

UCLA Hematology/Oncology - Burbank

Recruiting

Burbank, California, United States, 91505

UCLA Encino Specialty Care (Radiology)

Recruiting

Encino, California, United States, 91436

UCLA Hematology/Oncoclogy-Encino

Recruiting

Encino, California, United States, 91436

Kaiser Permanente Fontana Medical Center

Recruiting

Fontana, California, United States, 92335

Foothill Cardiology Glendora

Recruiting

Glendora, California, United States, 91741

Kaiser Permanente South Bay Medical center

Recruiting

Harbor City, California, United States, 90710

Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

Kaiser Permanente Alton/Sand Canyon Medical Offices

Recruiting

Irvine, California, United States, 92618

UCLA Downtown Los Angeles Primary & Specialty Care

Recruiting

Los Angeles, California, United States, 90017

Kaiser Permanente Los Angeles Medical Offices

Recruiting

Los Angeles, California, United States, 90027

Kaiser Permanente West Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90034

Ronald Reagan UCLA Medical Center, Drug Information Center

Recruiting

Los Angeles, California, United States, 90095

UCLA Cardiovascular Center

Recruiting

Los Angeles, California, United States, 90095

UCLA Hematology Oncology

Recruiting

Los Angeles, California, United States, 90095

UCLA Westwood Specialty Care

Recruiting

Los Angeles, California, United States, 90095

UCLA Santa Monica Cardiology

Recruiting

Los Angeles, California, United States, 90404

UCLA Montecito Primary & Specialty Care

Recruiting

Montecito, California, United States, 93108

Newport Diagnostics Center (Radiology)

Recruiting

Newport Beach, California, United States, 92660

Kaiser Permanente Ontario Medical Center

Recruiting

Ontario, California, United States, 91761

UC Irvine Health

Recruiting

Orange, California, United States, 92868

Kaiser Permanente Panorama City Medical Center, Medical Offices 3

Recruiting

Panorama City, California, United States, 91402

Foothill Cardiology Pasadena

Recruiting

Pasadena, California, United States, 91105

Southern California Heart Specialists

Recruiting

Pasadena, California, United States, 91105

UCLA Hematology/ Oncology- Pasadena

Recruiting

Pasadena, California, United States, 91105

UCLA Hematology Oncology - Porter Ranch

Recruiting

Porter Ranch, California, United States, 91326

UCLA Porter Ranch Primary & Specialty Care

Recruiting

Porter Ranch, California, United States, 91326

Kaiser Permanente Riverside Medical Center

Recruiting

Riverside, California, United States, 92505

Southern California Permanente Medical Group (SCPMG)

Recruiting

Riverside, California, United States, 92505

Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies)

Recruiting

San Diego, California, United States, 92108

Kaiser Permanente Zion Medical Center

Recruiting

San Diego, California, United States, 92120

UCSF Cancer Center MZ Phlebotomy

Recruiting

San Francisco, California, United States, 94115

UCSF Mount Zion Phlebotomy

Recruiting

San Francisco, California, United States, 94115

UCSF Parnassus Phlebotomy

Recruiting

San Francisco, California, United States, 94143

UCSF Investigational Drugs Pharmacy

Recruiting

San Francisco, California, United States, 94158

University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

Recruiting

San Francisco, California, United States, 94158

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94158

Diagnostic Medical Group of Southern California (Radiology)

Recruiting

San Gabriel, California, United States, 91776

Southern California Heart Centers

Recruiting

San Gabriel, California, United States, 91776

UCLA Hematology/Oncology - San Luis Obispo

Recruiting

San Luis Obispo, California, United States, 93401

Sierra Vista Regional Medical Center

Recruiting

San Luis Obispo, California, United States, 93405

Kaiser Permanente San Marcos Medical Offices

Recruiting

San Marcos, California, United States, 92078

UCLA Hematology/Oncology - Santa Monica

Recruiting

Santa Monica, California, United States, 90404

UCLA Simi Valley Alamo Specialty Care

Recruiting

Simi Valley, California, United States, 93065

Twin Cities Community Hospital

Recruiting

Templeton, California, United States, 93465

UCLA Thousand Oaks Primary & Specialty Care

Recruiting

Thousand Oaks, California, United States, 91360

UCLA Hematology/Oncology - Torrance

Recruiting

Torrance, California, United States, 90505

UCLA Torrance Lomita Specialty Care

Recruiting

Torrance, California, United States, 90505

UCLA Hematology-Oncology Clinic - Santa Clarita

Recruiting

Valencia, California, United States, 91355

UCLA Santa Clarita Primary & Specialty Care

Recruiting

Valencia, California, United States, 91355

UCLA Hematology/Oncology - Ventura

Recruiting

Ventura, California, United States, 93003

UCLA Ventura Cardiology

Recruiting

Ventura, California, United States, 93003

UCLA Hematology/Oncology - Westlake

Recruiting

Westlake Village, California, United States, 91361

Kaiser Permanente Woodland Hills Medical Center

Recruiting

Woodland Hills, California, United States, 91367

Medstar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Florida Cancer Specialists

Recruiting

Bonita Springs, Florida, United States, 34135

Florida Cancer Specialists

Recruiting

Bradenton, Florida, United States, 34205

Florida Cancer Specialists

Recruiting

Bradenton, Florida, United States, 34211

Florida Cancer Specialists

Recruiting

Cape Coral, Florida, United States, 33909

Florida Cancer Specialists

Recruiting

Fleming Island, Florida, United States, 32003

Florida Cancer Specialists

Recruiting

Fort Myers, Florida, United States, 33905

Florida Cancer Specialists

Recruiting

Fort Myers, Florida, United States, 33908

Florida Cancer Specialists

Recruiting

N. Venice, Florida, United States, 34275

Florida Cancer Specialists

Recruiting

Naples, Florida, United States, 34102

Florida Cancer Specialists

Recruiting

Port Charlotte, Florida, United States, 33980

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Florida Cancer Specialists Sarasota Memorial Hospital (SAD)

Recruiting

Sarasota, Florida, United States, 34239

Florida Cancer Specialists

Recruiting

Tallahassee, Florida, United States, 32308

Moffitt Cancer Center McKinley Hospital

Recruiting

Tampa, Florida, United States, 33612

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Florida Cancer Specialists

Recruiting

Venice, Florida, United States, 34285

Florida Cancer Specialists

Recruiting

Venice, Florida, United States, 34292

UChicago Medicine - River East

Recruiting

Chicago, Illinois, United States, 60611

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Accellacare - Deerfield

Recruiting

Deerfield, Illinois, United States, 60015

UChicago Medicine at Ingalls - Flossmoor

Recruiting

Flossmoor, Illinois, United States, 60422

UChicago Medicine Ingalls Memorial

Recruiting

Harvey, Illinois, United States, 60426

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

Recruiting

New Lenox, Illinois, United States, 60451

The University of Chicago Medicine Center for Advanced Care Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

UChicago Medicine at Ingalls - Tinley Park

Recruiting

Tinley Park, Illinois, United States, 60477

UMass Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

The Cancer & Hematology Centers

Recruiting

Big Rapids, Michigan, United States, 49307

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)

Recruiting

Detroit, Michigan, United States, 48202

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Recruiting

Farmington Hills, Michigan, United States, 48334

The Cancer & Hematology Centers

Recruiting

Grand Rapids, Michigan, United States, 49503

Cancer & Hematology Centers of Western Michigan, PC- Kit Storage

Recruiting

Grand Rapids, Michigan, United States, 49546

The Cancer & Hematology Centers

Recruiting

Grand Rapids, Michigan, United States, 49546

The Cancer & Hematology Centers

Recruiting

Holland, Michigan, United States, 49424

Karmanos Cancer Institute at McLaren Greater Lansing

Recruiting

Lansing, Michigan, United States, 48910

The Cancer & Hematology Centers

Recruiting

Norton Shores, Michigan, United States, 49444

MSK Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

MSK Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

MSK Bergen

Recruiting

Montvale, New Jersey, United States, 07645

MSK Commack

Recruiting

Commack, New York, United States, 11725

MSK Wesrchester

Recruiting

Harrison, New York, United States, 10604

Memorial Sloan Kattering Cancer Centre- Investigational Drug Service Pharmacy

Recruiting

Long Island City, New York, United States, 11101

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

Recruiting

New York, New York, United States, 10021

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Evelyn H. Lauder Breast and Imaging Centre (BAIC)

Recruiting

New York, New York, United States, 10065

Memorial Sloan Kettering Cancer Center - Main Campus

Recruiting

New York, New York, United States, 10065

Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

MSK nassau

Recruiting

Uniondale, New York, United States, 11553

Carolinas Medical Center (biopsy only)

Recruiting

Charlotte, North Carolina, United States, 28203

Carolinas Medical Center Investigational Drug Services

Recruiting

Charlotte, North Carolina, United States, 28204

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Atrium Health Mercy (biopsy only)

Recruiting

Charlotte, North Carolina, United States, 28207

Atrium Health University City (biopsy only)

Recruiting

Charlotte, North Carolina, United States, 28262

Levine Cancer Institute University

Recruiting

Charlotte, North Carolina, United States, 28262

Levine Cancer Institute - Ballantyne

Recruiting

Charlotte, North Carolina, United States, 28277

Atrium Health Cabarrus (biopsy only)

Recruiting

Concord, North Carolina, United States, 28025

Levine Cancer Institute Concord

Recruiting

Concord, North Carolina, United States, 28025

Levine Cancer Institute- Gaston

Recruiting

Gastonia, North Carolina, United States, 28054

Atrium Health Union (biopsy only)

Recruiting

Monroe, North Carolina, United States, 28112

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Ohio State University Hospital

Recruiting

Columbus, Ohio, United States, 43210

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

OSU Wexner Medical Center & James Cancer Hospital

Recruiting

Columbus, Ohio, United States, 43210

The James Cancer Hospital & Solove Research Institute at The OSU Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

The James Outpatient Care West Campus

Recruiting

Columbus, Ohio, United States, 43221

OU Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

OU Medical Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Froedtert Hospital/Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T3N 4N1

BC Cancer - Vancouver Fairmont Medical Building

Recruiting

Vancouver, British Columbia, Canada, V5Z 1H7

BC Cancer - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Urothelial Cancer
  • Bladder Cancer
  • HER2 Mutations
  • HER2 Overexpression
  • HER2 Amplification
  • RC48
  • Seattle Genetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Seagen, a wholly owned subsidiary of Pfizer on 2026-07-22.