Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical Cystectomy
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|ClinicalTrials.gov Identifier: NCT03171493|
Recruitment Status : Active, not recruiting
First Posted : May 31, 2017
Last Update Posted : May 8, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma||Biological: MV-NIS||Phase 1|
Study VYR-MV1-102 is a Phase 1 study designed to determine the tolerability, feasibility and preliminary efficacy of attenuated MV-NIS virus after neoadjuvant intravesical administration prior to RC in patients with UC who are ineligible for current neoadjuvant chemotherapy.
Investigators will use a novel adaptive trial design that varies the time between TURBT, virus administration and RC.
Currently, intravesical administration of BCG is delayed four to six weeks after TURBT to reduce the likelihood of systemic BCG absorption and BCG sepsis. Given this clinical safety precedent, Investigators propose initial patients be treated within one week of RC to maximize the time between TURBT and MV-NIS administration.
Subsequent patients will be treated earlier before RC (up to 29 days prior), thereby reducing the interval between TURBT and virus administration to maximize the treatment duration before RC. An expansion cohort will also be used to test the feasibility, tolerability and efficacy of two repeat MV-NIS doses prior to RC. MV-NIS has been proven safe at a dose of 1x1011 TCID50 intravenously in patients lacking MV immunity (Russell 2014), which allays concern for systemic toxicity after intravesical administration even if post-TURBT administration results in systemic MV-NIS absorption.
Pathologic downstaging and CR (assessed by T0 rate) at surgery are secondary endpoints, designed to give an early indication of efficacy potential. This will facilitate future virotherapy strategies targeting replicative tumor destruction and stimulation of systemic anti-tumor immunity as possible strategies for neoadjuvant and bladder-sparing therapy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Neoadjuvant Intravesical NIS Measles Virus (MV-NIS) in Patients Undergoing Cystectomy for Urothelial Carcinoma But Ineligible for Neoadjuvant Cisplatin-based Chemotherapy|
|Actual Study Start Date :||July 20, 2018|
|Estimated Primary Completion Date :||May 30, 2023|
|Estimated Study Completion Date :||May 30, 2023|
Experimental: Intravesical MV-NIS therapy prior to radical cystectomy
MV-NIS will be administered via intravesical instillation as a single dose on Day 1 (7, 14, 21 or 28 days before cystectomy) or two doses on Day 1 and 15 (14 and 28 days before cystectomy).
Attenuated measles virus encoding NIS (MV-NIS)
- Number of participants with intravesical MV-NIS treatment related adverse events (NCI CTCAE; Version 4.03) [ Time Frame: 30 days after cystectomy ]Assessment of safety and toxicity of intravesical MV-NIS administration in patients with Urothelial Carcinoma undergoing cystectomy
- Pathologic staging at time of cystectomy following intravesical MV-NIS therapy [ Time Frame: Measured in bladder specimen following cystectomy (up to 29 days following MV-NIS administration) ]Preliminary assessment of antitumor efficacy of intravesical MV-NIS therapy
- pT0 rate at time of cystectomy following intravesical MV-NIS therapy [ Time Frame: Measured in bladder specimen following cystectomy (up to 29 days following MV-NIS administration) ]Preliminary assessment of antitumor efficacy of intravesical MV-NIS therapy
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171493
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, Louisiana|
|New Orleans, Louisiana, United States, 70121|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Director:||Alice Bexon, MD||CMO - Medical Monitor|
|Responsible Party:||Vyriad, Inc.|
|Other Study ID Numbers:||
|First Posted:||May 31, 2017 Key Record Dates|
|Last Update Posted:||May 8, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Muscle Invasive Bladder Cancer
chemotherapy for bladder cancer
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type