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.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||July 20, 2018||Phase 1||Interventional|
Primary Outcome 1 - Measure: Number of participants with intravesical MV-NIS treatment related adverse events (NCI CTCAE; Version 4.03)
Primary Outcome 1 - Time Frame: 30 days after cystectomy
- 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
- 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
- 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
- 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
- Allergy to measles vaccine or history of severe reaction to prior measles vaccination.
- History of organ transplantation.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Shruthi Naik, PhD
|University of Miami
Miami, Florida 33136
New Orleans, Louisiana 70121
Rachel Graham, RN
Rochester, Minnesota 55905