Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radi… (NCT03171493) | Clinical Trial Compass
CompletedPhase 1
Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical Cystectomy
United States8 participantsStarted 2018-07-20
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 f…
What they're measuring
1
Number of participants with intravesical MV-NIS treatment related adverse events (NCI CTCAE; Version 4.03)