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BRIEF TITLE: Neoadjuvant Intravesical NIS Measles Virus (MV-NIS) in Patients Undergoing Cystectomy for Urothelial Carcinoma But Ineligible for Neoadjuvant Cisplatin-based Chemotherapy

Neoadjuvant Intravesical NIS Measles Virus (MV-NIS) in Patients Undergoing Cystectomy for Urothelial Carcinoma But Ineligible for Neoadjuvant Cisplatin-based Chemotherapy


  • Org Study ID: VYR-MV1-102
  • Secondary ID:
  • NCT ID: NCT03171493
  • NCT Alias:
  • Sponsor: Vyriad, Inc. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting July 20, 2018 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of participants with intravesical MV-NIS treatment related adverse events (NCI CTCAE; Version 4.03)

Primary Outcome 1 - Time Frame: 30 days after cystectomy

Condition:

  • Urothelial Carcinoma

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Barb H Duckett

Phone: 507-289 0944

Email: bduckett@vyriad.com

Location

Facility Status Contact
Mayo Clinic
Rochester, Minnesota 55905
United States
Recruiting Tessa Kroeninger
507-538-6107
kroeninger.tessa@mayo.edu