IUSCC-0551; A Phase I/Ib Open Label Dose Finding Study to Evaluate Safety Pharmacodynamics and Efficacy of Pembrolizumab (MK-3475) in Combination with Vorinostat in Patients with Advanced Renal or Urothelial Cell Carcinoma

Are you eligible to participate in this study?

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

  • Conditions: bladder cancer | kidney cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria
Have measurable disease
Adequate organ function
Have an archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment
Exclusion Criteria
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
Has active TB
Hypersensitivity to pembrolizumab or any of its excipients
Has had prior anti-cancer monoclonal antibody within 4 weeks prior to Cycle 1 Day 1 or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1 Day 1 or who has not recovered from adverse events due to a previously administered agent
Has a known addition malignancy that is progressing or requires active treatment
Has known active central nervous system metastases and/or carcinomatous meningitis
Has an active autoimmune disease that has required systemic treatment in the past 2 years
Has known history of, or any evidence of active, non-infectious pneumonitis
Has an active infection requiring systemic therapy
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment
Has received prior therapy with anti-PD-1, anti-PD-l1, or an anti-PD-L2 agent
Has a known history of Human Immunodeficiency Virus (HIV)
Has a known active Hepatitis B or Hepatitis C
Has received a live vaccine within 30 days of planned start of study therapy

Recruitment Status

Closed

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