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
Condition: Advanced Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Pazopanib
Intervention description: Participants received 800mg of pazopanib once daily orally. Pazopanib was supplied as aqueous film-coated tablets containing 200 mg or 400 mg.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: renal cell carcinoma; metastatic renal cell; pazopanib; checkpoint inhibitor therapy; RCC; hypernephroma; renal adenocarcinoma; kidney cancer; renal cancer; adult

Summary:

      The main purpose of this study was to assess the progression-free survival (PFS) based on
      local investigator assessment of pazopanib in participants with advanced and/or metastatic
      renal cell carcinoma (mRCC) following prior treatment with immune checkpoint inhibitors
      (ICI).
    

Eligibility criteria:

        Key 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