A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)

Official Title

A Phase 3, Multinational, Randomized, Open-Label, Parallel-Arm Study Of Avelumab (MSB0010718C) In Combination With Axitinib (Inlyta(Registered)) Versus Sunitinib (Sutent(Registered)) Monotherapy In The First-Line Treatment Of Patients With Advanced Renal Cell Carcinoma

Summary:

This is a phase 3 randomized trial evaluating the anti-tumour activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS) in PD-L1 positive patients
  • Overall Survival in PD-L1 positive patients
Secondary Outcome:
  • Overall Survival (OS) in unselected patients
  • Number of participants with Objective Response (OR)
  • Disease Control (DC)
  • Time to Tumour Response (TTR)
  • Duration of response (DR)
  • Progression Free Survival (PFS) by Investigator assessment
  • Trough plasma concentration (Ctrough) of avelumab
  • Trough plasma concentration (Ctrough) of axitinib
  • Maximum plasma concentration (Cmax) of axitinib
  • Anti-Drug Antibody (ADA) levels of avelumab/Neutralizing antibodies titers for MSB0010718C
  • Tumour tissue biomarker status
  • Overall Survival (OS) in biomarker-positive and biomarker-negative subgroups
  • Change From Baseline in FACT-Kidney Symptom Index (FKSI)-19
  • Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Health State Profile
  • Progression Free Survival (PFS) in biomarker-positive and biomarker-negative subgroups
  • Objective Response (OR) in biomarker-positive and biomarker-negative subgroups
  • Disease Control (DC) in biomarker-positive and biomarker-negative subgroups
  • Time To Response (TTR) in biomarker-positive and biomarker-negative subgroups
  • Duration of Response (DR) in biomarker-positive and biomarker-negative subgroups
  • Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Visual Analogic Scale
  • Time to treatment discontinuation/failure due to toxicity (TTF)
  • Treatment discontinuation/failure due to toxicity
  • PFS on next-line therapy (PFS2)
  • Progression Free Survival (PFS) in unselected patients

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