A Phase II Clinical Study of Intravesical Ruvidar® in Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma In-Situ (CIS) or Patients Who Are Intolerant to BCG Therapy (Study II)
This is a phase II, open-label, single-arm, multi-center Study conducted in Canada and the United States. Patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Carcinoma In-Situ (CIS) (with or without resected papillary disease (Ta, T1)) that are considered Bacillus Calmette-Guerin (BCG)-Unresponsive or who are intolerant to BCG therapy. BCG-Unresponsive is at least one of the following: At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy; or, at least five of six doses of an initial induction course plus at least two of six doses of a second induction course. Patients experiencing disease relapse within 12 months after finishing the second course of BCG therapy are considered BCG-Unresponsive. The Study will consist of 90 patients who will undergo one (1) Study Procedure, with up to two (2) additional re-induction Study Procedures based on patient response.
• Be willing and able to provide a written Informed Consent Form (ICF) for the Study.
• Be \> 18 years of age on day of signing ICF.
• Have histologically confirmed NMIBC CIS via biopsy with/without resected papillary disease (Ta, T1) (high grade) using the 2004 World Health Organization (WHO) / International Society of Urologic Pathology classification system. The most recent cystoscopy / TURBT must have been performed within 12 weeks of the Study Procedure date to confirm: histology, grade and stage.
• Intolerant to BCG or considered BCG-Unresponsive, which is at least one of the following:
‣ At least five of six doses of an initial induction course, plus at least two of three doses of maintenance therapy, or
⁃ At least five of six doses of an initial induction course, plus at least two of six doses of a second induction course.
• Are not candidates for cystectomy on medical grounds or refuse radical cystectomy.
• Have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
• Have satisfactory bladder function. Ability to retain Study Drug for a minimum of 60 minutes.
• Are available for the duration of the Study including follow-up (approximately 15 months).
• Female patients of childbearing potential must have a negative Human Chorionic Gonadotropin (HCG) pregnancy test taken during the screening visit and confirmed prior to the Study Procedure.
⁃ Female patients of childbearing potential must be willing to use 2 methods of birth control (i.e.: oral contraceptive, pills, diaphragm or condoms) or be surgically sterile, or abstain from heterosexual activity for two weeks after the Study Procedure. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>1 year.