Perlmutter Cancer Center

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Bladder Cancer
• Age: Between 18 years - 100 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1) BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without resected papillary tumors who are indicated for, ineligible for, or have elected not to undergo cystectomy: persistent high-grade disease (Ta, T1, or Tis) or recurrence within 6 months of receiving at least 2 courses of intravesical BCG (at least 5 of 6 induction doses and at least 2 of 3 maintenance doses). 2) T1 high grade disease residual at the first evaluation following induction BCG (at least 5 of 6 doses). Patients who have previously been treated with an investigational or approved checkpoint inhibitor (e.g. pembrolizumab) and failed treatment are eligible for inclusion 30 days post-treatment (Phase 1) or 3 months post-treatment (Phase 2). 3) Male or non-pregnant, non-lactating female,
  

You may not be eligible for this study if the following are true:

• 1) Any other malignancy diagnosed within 1 year of study entry (except basal or squamous cell skin cancers or noninvasive cancer of the cervix) is excluded. 2) Concurrent treatment with any chemotherapeutic agent. Treatment with pembrolizumab within 30 days (Phase 1) or 3 months (Phase 2) prior to Screening. 3) Treatment with last therapeutic agent within 30 days of Screening (Phase 1 and Phase 2) or treatment with an investigational checkpoint inhibitor within 3 months of Screening (Phase 2 only).