Clinical Trials /

Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical Cystectomy

NCT03171493

Description:

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.

Related Conditions:
  • Bladder Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Trial of Intravesical Measles Virotherapy in Patients With Bladder Cancer Who Are Undergoing Radical Cystectomy
  • Official Title: Neoadjuvant Intravesical NIS Measles Virus (MV-NIS) in Patients Undergoing Cystectomy for Urothelial Carcinoma But Ineligible for Neoadjuvant Cisplatin-based Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: VYR-MV1-102
  • NCT ID: NCT03171493

Conditions

  • Urothelial Carcinoma

Interventions

DrugSynonymsArms
MV-NISIntravesical MV-NIS therapy prior to radical cystectomy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Intravesical MV-NIS therapy prior to radical cystectomyExperimentalMV-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).
  • MV-NIS

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with intravesical MV-NIS treatment related adverse events (NCI CTCAE; Version 4.03)
Time Frame:30 days after cystectomy
Safety Issue:
Description:Assessment of safety and toxicity of intravesical MV-NIS administration in patients with Urothelial Carcinoma undergoing cystectomy

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:Preliminary assessment of antitumor efficacy of intravesical MV-NIS therapy
Measure: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)
Safety Issue:
Description:Preliminary assessment of antitumor efficacy of intravesical MV-NIS therapy

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Vyriad, Inc.

Trial Keywords

  • Bladder cancer, Radical cystectomy

Last Updated

September 17, 2020