Last updated on August 2020

Study of Efficacy Safety and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Prior Checkpoint Inhibitor Treatment

Are you eligible to participate in this study?

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

  • Conditions: Metastatic Renal Cell Carcinoma | Advanced Renal Cell Carcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Patient is 18 years old at the time of informed consent.
  • Patient has histologically confirmed locally recurrent or metastatic predominantly clear cell renal cell carcinoma.
  • Patient must have measurable disease based on RECIST 1.1 criteria
  • Patient must have received prior systemic therapy with an immune checkpoint inhibitor (monotherapy or combination) as 1st or 2nd line RCC treatment. Note: patients with prior mTOR inhibitor or TKI treatment as monotherapy or in combination with immune checkpoint inhibitor are allowed; however, treatment with immune checkpoint inhibitor (monotherapy or in combination) must have been the last treatment prior to study entry.
  • Last dose of immune checkpoint inhibitor therapy must have been received 4 or more weeks before start of study treatment
  • Patient must have a Karnofsky performance status 70%.

Exclusion Criteria:

  • Renal cell carcinoma without any clear (conventional) cell component
  • History or evidence of central nervous system (CNS) metastases (patients with pretreated metastases are eligible under certain conditions)
  • Prior treatment with pazopanib
  • Prior treatment with bevacizumab that was not given in combination with immune checkpoint inhibitor therapy.
  • Prior treatment with more than 2 lines of therapy (combination treatments are considered 1 line of therapy)
  • Patient has not recovered from toxicity from prior immune checkpoint inhibitor therapy. Recovery is defined as NCI-CTCAE Grade 1, except for liver function test levels which must be <Grade 1.
  • Disease recurrence less than 6 months from the last dose of prior neoadjuvant or adjuvant therapy (including VEGF-R TKI)
  • Patients receiving prohibited concomitant medications that cannot be discontinued or replaced by safe alternative medication at least 5 half-lives of the concomitant medication or 7 days, whichever is longer, prior to the start of pazopanib treatment.
  • Administration of any investigational drug within 4 weeks prior to the first dose of study treatment

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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