Study Details

Open

Trial of Intravesical Gemcitabine and Pembrolizumab in Bladder Cancer Patients

Tis trial is designed to assess outcomes in patients with BCG-unresponsive NMIBC who are receiving gemcitabine in combination with pembrolizumab.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

The study involves physical exam, vital signs, blood draws for labs and research, variety of imaging procedures that include CT and PET scans, submission of biopsy tissue, paper questionnaires, and study drug.

Incentives

MK-3475 (pembrolizumab) while participant is part of the study.

Total length of participation:
Approximately 6yrs.

Looking for Specific Volunteers

Able to participate:

Willing and able to provide written informed consent (ICF) and HIPAA authorization for the release of personal health information, or have a legally authorized representative
The treating physician must deem the patient unfit for radical cystectomy or the patient must refuse radical cystectomy.
18 years of age or older.
All patients must have histologically confirmed urothelial cancer of the bladder within 60 days prior to registration.
Because this study involves an agent with known genotoxic, mutagenic, and teratogenic effects, participants must not be pregnant or nursing.

Not eligible if:

Patients must not have received live vaccines within 30 days of study drug administration. COVID-19 vaccinations are permitted.
Patients must not have a known history of Hepatitis B or known active Hepatitis C virus infection.
Hypersensitivity to any of the study treatments, excipients, or drugs of similar chemical classes.
HIV-infected patients who have been on effective antiretroviral therapy for at least 6 months and have an undetectable viral load are eligible.
Active autoimmune disease that requires continued therapy within 24 months prior to registration.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

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

Primary Visit Location

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

20-0686

ClinicalTrials.gov

NCT04164082