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

NCT03171493 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: VYR-MV1-102
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

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.

Conditions

Urothelial Carcinoma

Keywords

Bladder cancer; TURBT; Radical cystectomy; BCG; Muscle Invasive Bladder Cancer; Intravesical; chemotherapy for bladder cancer; Oncolytic

Outcome Measures

Primary Outcomes (1)

• Number of participants with intravesical MV-NIS treatment related adverse events (NCI CTCAE; Version 4.03)

  Assessment of safety and toxicity of intravesical MV-NIS administration in patients with Urothelial Carcinoma undergoing cystectomy

  30 days after cystectomy

Secondary Outcomes (2)

• Pathologic staging at time of cystectomy following intravesical MV-NIS therapy

  Measured in bladder specimen following cystectomy (up to 29 days following MV-NIS administration)

• pT0 rate at time of cystectomy following intravesical MV-NIS therapy

  Measured in bladder specimen following cystectomy (up to 29 days following MV-NIS administration)

Study Arms (1)

Intravesical MV-NIS therapy prior to radical cystectomy

EXPERIMENTAL

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

Interventions

MV-NIS BIOLOGICAL

Attenuated measles virus encoding NIS (MV-NIS)

Intravesical MV-NIS therapy prior to radical cystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vyriad, Inc.: lead
• Mayo Clinic: collaborator

Study Sites (3)

University of Miami

Miami, Florida, 33136, United States

Location

Ochsner Health

New Orleans, Louisiana, 70121, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Alice Bexon, MD

  CMO - Medical Monitor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: May 31, 2017
• Study Start: July 20, 2018
• Primary Completion: February 11, 2021
• Study Completion: May 12, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)