Open

Bladder Cancer Study

RC48G001: 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

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

The study includes blood draws, physical exams, CT and/or MRI's. ECG's. Echocardiograms, completion of questionnaires, and study treatment.

Incentives

In-person visits:
More than 10

Phone or online visits:
Survival follow-up visits every 12 weeks.

Total length of participation:
Up to 3+ years

Looking for Specific Volunteers

Able to participate:

You have expected survival of at least 12 weeks.
You have a diagnosis of locally advanced unresectable or metastatic bladder cancer.
You have baseline cardiac, bone marrow, hepatic, renal, and coagulation functions based on protocol requirements.
You do not have evidence of residual cancer or metastasis after surgery to remove the bladder.
You are able and willing to provide archival or fresh tissue.

Not eligible if:

You have received antitumor treatment within two weeks prior to the start of the study.
You had a major surgery that you are not fully recovered from within four weeks of study dosing.
You have an acute, chronic, or symptomatic infection.
You have uncontrolled cardiac disease per protocol.
You have a known hypersensitivity to the durg disitamab vedotin or any of its components.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Matthew Milowsky
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Bladder)

IRB Number

24-0094

ClinicalTrials.gov

NCT04879329

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH. This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

Helpful Links

Questions?

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