Bladder Cancer Research

For enrollment information involving the following trials, please contact a member of our research support staff.

Genistein Therapy (GIBBS STUDY)

BMS-CA2099UT


Genistein Therapy (GIBBS Study)

Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravescial Therapy

Inclusion Criteria:

  • Diagnosis of superficial bladder cancer

  • Scheduled for BCG intravesical therapy

  • Willing and able to give blood sample

  • Willing and able to fill out a pill diary to ensure compliance

Exclusion Criteria:

  • Pregnant patients

  • Diagnosis of invasive bladder cancer

  • HIV positive or immunocompromised

  • Presence of concurrent second cancer (active, not history)

Principal Investigator: Omer Kucuk, MD (Department of Hematology and Medical Oncology)

Co-Investigators & Collaborators: Kenneth Ogan, MD, Viraj Master, MD, PhD, John Pattaras, MD


BMS-CA2099UT

A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined with Intravesical BCG in Participants with BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer (CheckMate 9UT: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9UT)

Inclusion Criteria:

  • Pathologically demonstrated BCG-unresponsive*, high-risk NMIBC defined as carcinoma in situ (CIS) with or without papillary component, any T1, or Ta high-grade lesions; diagnosis required within 8 weeks (56 days) prior to starting treatment and must be confirmed by the Pathology Review Committee (PRC).

  • Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma.

  • ECOG performance status of 0-1.

Exclusion Criteria:

  • Participants with an active, known or suspected autoimmune disease.

  • Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.

  • Prior malignancy active within the previous three years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer with evidence of undetectable Prostate Specific Antigen (PSA), or carcinoma in situ of the cervix or breast.

  • Participants with a personal or family (ie, in a first-degree relative) history of cytochrome b5 reductase deficiency (previously called methemoglobin reductase deficiency) or other diseases that put them at risk of methemoglobinemia. All participants will be screened for methemoglobin levels prior to randomization.

  • Participants with a history of G6PD deficiency or other congenital or autoimmune hemolytic disorders. All participants will be screened for G6PD deficiency prior to randomization.

  • Evidence of locally advanced disease or metastatic bladder cancer as seen in crosssectional images of the chest, abdomen, and pelvis.

  • Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment.

  • UC and/or CIS in the prostatic urethra within 12 months of enrollment.

  • Locally advanced disease demonstrated by pelvic examination, preferably performed under anesthesia.

  • Previous or concurrent muscle invasive or disseminated/metastatic bladder cancer.

Principal Investigator: Viraj Master, MD, PhD

Co-Investigators & Collaborators: Mehmet Bilen, MD (Department of Hematology and Medical Oncology), Mehrdad Alemozaffar, MD, Kenneth Ogan, MD

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