Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical Cystectomy
Trial Status: Active
This is a Phase 1 study designed to test the tolerability and feasibility of intravesical therapy with an attenuated Measles virus (MV-NIS) in patients with urothelial carcinoma who are undergoing radical cystectomy but are ineligible or do not desire neoadjuvant chemotherapy.
- Diagnosis of Urothelial carcinoma (UC) of the bladder, with histologic confirmation of primary UC pathology; indication for Radical cystectomy (RC); ineligibility for platinum-based neoadjuvant chemotherapy
- ECOG Performance Status (PS) 0 or 1.
- Ability to provide informed consent.
- Willingness to comply with all required protocol procedures including providing biologic specimens and returning to the clinical study site for follow up visits.
- Performance status sufficient to undergo RC (in the opinion of the enrolling urologist) including adequate hematological, liver and kidney function
- Must be willing to implement contraception throughout study and for 30 days following RC.
- Variant UC pathology including but not limited to micropapillary, signet ring,sarcomatoid, and clear cell variants.
- Patients with any other prior malignancy are not allowed except for the following: History of or concurrent non-invasive UC involving a portion of urinary tract outside of the bladder; Adequately treated basal cell or squamous cell skin cancer; In situ cervical cancer; Adequately treated Stage I or II cancer from which the patient is currently incomplete remission or other cancer from which the patient has been disease-free for 2 years.
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- Any of the following prior therapy: Chemotherapy ≤ 3 weeks prior to registration. Biologic therapy ≤ 4 weeks prior to registration. Radiation therapy ≤ 3 weeks prior to registration
- Other concurrent investigational therapy (utilized for a non-FDA-approved indication and in the context of a research investigation).
- Pregnant women.
- Nursing women.
- Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of study drug treatment.
- Allergy to measles vaccine or history of severe reaction to prior measles vaccination.
- History of organ transplantation.
Mayo Clinic in Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center
Mayo Clinic in Rochester
Contact: Tessa Kroeninger
Trial Phase Phase I
Trial Type Treatment
- Primary ID VYR-MV1-102
- Secondary IDs NCI-2019-03105
- Clinicaltrials.gov ID NCT03171493