Brief Title: V940 and BCG in People With Bladder Cancer (V940-011/INTerpath-011)

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: BCG Arms: Event-free Survival (EFS)

Primary Outcome 1 - Timeframe: Up to approximately 5 years

Primary Outcome 2 - Measure: V940 Monotherapy Arm: Complete Response Rate (CRR)

Primary Outcome 2 - Timeframe: Up to approximately 5 years

CONDITION

• Urinary Bladder Neoplasms
• Non-Muscle Invasive Bladder Neoplasms
• Carcinoma in Situ

ELIGIBILITY

Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Is an individual whose most recent TURBT was performed within 12 weeks before randomization/allocation and showed BICR-confirmed high-risk NMIBC histology
BCG Arms:
* Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder

- * Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG
V940 Monotherapy Arm:
* Has CIS +/-papillary non-muscle invasive UC of the bladder

- * Is ineligible for, or refusing, any IVESIC therapy

- * Is either BCG-naïve (as defined above) or BCG-exposed but did not receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG

- * Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC

- * Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions

- * Has a known additional malignancy that is progressing or has required active treatment within the last 3 years

- * Has had a myocardial infarction within 6 months of randomization/allocation

- * Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation

- * Has received prior treatment with a cancer vaccine

- * Has immunodeficiency or is receiving chronic systemic steroid therapy

- * Has active autoimmune disease that has required systemic treatment in the last 2 years

- * Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU)
BCG Arms:
* Has current active tuberculosis

- * Has a known history of HIV infection
V940 Monotherapy Arm:
- HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme LLC

Overall Contact

Name: Toll Free Number

Phone: 1-888-577-8839

Email: [email protected]

LOCATION