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:

- 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
- 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