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RECRUITINGPHASE2

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

A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

NCT04879329•Seagen, a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+27 more criteria

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)
+30 more criteria

Locations (221)

Banner Gateway Medical Center

Gilbert, Arizona, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Kaiser Permanente Anaheim Kraemer Medical Offices

Anaheim, California, United States

Foothill Cardioology

Arcadia, California, United States

Kaiser Permanente Baldwin Park Medical Center

Baldwin Park, California, United States

Kaiser Permanente Bellflower Medical Offices

Bellflower, California, United States

Beverly Hills Multi-Specialties Practice

Beverly Hills, California, United States

Providence Saint Joseph Medical Center

Burbank, California, United States

UCLA Burbank Cardiology

Burbank, California, United States

UCLA Hematology/Oncology - Burbank

Burbank, California, United States

Key Dates

Start Date

May 3, 2022

Primary Completion Date

December 11, 2026

Completion Date

April 14, 2029

Last Updated

January 7, 2026

Enrollment

372

ESTIMATED participants

Conditions

Urothelial Carcinoma

Interventions

disitamab vedotin

DRUG

pembrolizumab

DRUG

Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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