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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 : October 1, 2019
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Vyriad, Inc.

Tracking Information
First Submitted Date  ICMJE March 24, 2017
First Posted Date  ICMJE May 31, 2017
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE July 20, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03171493 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical Cystectomy
Official Title  ICMJE Neoadjuvant Intravesical NIS Measles Virus (MV-NIS) in Patients Undergoing Cystectomy for Urothelial Carcinoma But Ineligible for Neoadjuvant Cisplatin-based Chemotherapy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urothelial Carcinoma
Intervention  ICMJE Biological: MV-NIS
Attenuated measles virus encoding NIS (MV-NIS)
Study Arms  ICMJE 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).
Intervention: Biological: MV-NIS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2017)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Barb H Duckett 507-289 0944 bduckett@vyriad.com
Contact: Shruthi Naik, PhD 507-722-0891
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03171493
Other Study ID Numbers  ICMJE VYR-MV1-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Vyriad, Inc.
Study Sponsor  ICMJE Vyriad, Inc.
Collaborators  ICMJE Mayo Clinic
Investigators  ICMJE Not Provided
PRS Account Vyriad, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP