RecruitingPhase 2NCT04879329

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

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Enrollment

372 participants

Start Date

May 3, 2022

Study Type

INTERVENTIONAL

Conditions

Urothelial Carcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests disitamab vedotin (an antibody-drug conjugate that targets HER2-positive cancer cells) alone or in combination with pembrolizumab (an immunotherapy) in patients with locally advanced or metastatic urothelial cancer (bladder and urinary tract cancer) that expresses the HER2 protein. **You may be eligible if...** - You have confirmed, locally advanced or metastatic urothelial cancer that cannot be surgically removed - Your tumor tests positive for HER2 expression (IHC 1+, 2+, or 3+) - You have received 1–2 prior systemic treatments including at least one platinum-based chemotherapy regimen (for most groups); one group (Cohort C) accepts patients with no prior treatment who are eligible for chemotherapy - Your overall health score is 0–2 (ECOG) depending on the group **You may NOT be eligible if...** - Your tumor does not express HER2 - You have received more than 2 prior lines of treatment (for most groups) - You have serious unresolved side effects from prior therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGdisitamab vedotin

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

DRUGpembrolizumab

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

Locations(223)

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

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States

UCLA Encino Specialty Care (Radiology)

Encino, California, United States

UCLA Hematology/Oncoclogy-Encino

Encino, California, United States

Kaiser Permanente Fontana Medical Center

Fontana, California, United States

Foothill Cardiology Glendora

Glendora, California, United States

Kaiser Permanente South Bay Medical center

Harbor City, California, United States

Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Kaiser Permanente Alton/Sand Canyon Medical Offices

Irvine, California, United States

UCLA Downtown Los Angeles Primary & Specialty Care