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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 : Recruiting
First Posted : May 31, 2017
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Vyriad, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Biological: MV-NIS Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles

Arm Intervention/treatment
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).
Biological: MV-NIS
Attenuated measles virus encoding NIS (MV-NIS)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.

Information from the National Library of Medicine

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


Contacts
Contact: Barb H Duckett 507-289 0944 bduckett@vyriad.com
Contact: Shruthi Naik, PhD 507-722-0891

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tessa Kroeninger    507-538-6107    kroeninger.tessa@mayo.edu   
Contact: Tanner Miest, MD, PhD       miest.tanner@mayo.edu   
Principal Investigator: Bradley Leibovich, MD         
Sub-Investigator: Tanner Miest, MD, PhD         
Sponsors and Collaborators
Vyriad, Inc.
Mayo Clinic

Responsible Party: Vyriad, Inc.
ClinicalTrials.gov Identifier: NCT03171493     History of Changes
Other Study ID Numbers: VYR-MV1-102
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vyriad, Inc.:
Bladder cancer, Radical cystectomy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms