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

Inclusion Criteria

• Histologically confirmed locally recurrent or metastatic predominantly clear cell renal cell carcinoma.
• Measurable disease based on RECIST 1.1 criteria
• 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 were 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 received 4 or more weeks before start of study treatment
• Karnofsky performance status ≥70%.
• Potassium, sodium, calcium and magnesium within normal limits of the central laboratory Key

Exclusion Criteria

• Renal cell carcinoma without any clear (conventional) cell component
• History or evidence of central nervous system (CNS) metastases (patients with pretreated metastases were 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 were considered 1 line of therapy)
• Not recovered from toxicity from prior immune checkpoint inhibitor therapy. Recovery was 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 could not be discontinued or replaced by safe alternative medication at least 5 half-lives of the concomitant medication or 7 days, whichever was longer, prior to the start of pazopanib treatment.
• Administration of any investigational drug within 4 weeks prior to the first dose of study treatment