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

Official Title

A Prospective International Multicentre Phase II Study to Evaluate the Efficacy, Safety and Quality of Life of Pazopanib in Patients With Advanced and/or Metastatic Renal Cell Carcinoma After Previous Therapy With Checkpoint Inhibitor Treatment

Summary:

An international, multicentre, 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.

Trial Description

Primary Outcome:

  • Progression free survival based on local investigator assessment
Secondary Outcome:
  • Overall response rate and clinical benefit rate based on local investigator assessment
  • Overall survival
  • Duration of response in patients with confirmed complete response or partial response
  • Incidence of Treatment-emergent Adverse Events (safety and tolerability)
  • Change from baseline in FSKI-DRS score
  • Change from baseline in EQ-5D-5L score

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society