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

• Status: Completed
• Trial end date: 2021-08-10
• Target enrollment: 0
• Participant gender: All

Summary

An international, multicenter, single arm Phase II trial to determine the efficacy, safety and quality of life of pazopanib treatment after previous therapy with immune checkpoint treatment. Approximately 100 patients will be enrolled, with approximately 40 of those patients receiving pazopanib as 2nd-line therapy. Patients will receive treatment with standard dose pazopanib until disease progression, unacceptable toxicity, pregnancy, death, discontinuation from the study treatment for any other reason or until study end. All patients will be followed for survival. Patients who discontinue treatment without documented disease progression will be followed for efficacy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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%.

• Patient must have potassium, sodium, calcium and magnesium within normal limits of the central laboratory

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