Neoadjuvant AXITINIB and AVELUMAB for Patients With Localized Clear-cell RCC and a Moderate to High Risk

Condition: Renal Cell Carcinoma


  • Drug: Axitinib
  • Drug: Avelumab

Purpose: a monocenter, open label, single arm, phase II study of the combination of axitinib with avelumab as neoadjuvant therapy in patients with intermediate to high-risk non-metastatic RCC.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03341845

Sponsor: The Netherlands Cancer Institute

Primary Outcome Measures:

  • Measure: number of patients with partial remission
  • Time Frame: week 12 of neoadjuvant treatment
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: toxicity
  • Time Frame: up to 90 days after end of treatment
  • Safety Issue:
  • Measure: event free survival and overall survival
  • Time Frame: assessed up to 10 years
  • Safety Issue:

Estimated Enrollment: 40

Study Start Date: March 28, 2018

Phase: Phase 2


  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Signed and written informed consent
  • Male or female patients age ≥ 18 years
  • Histologically confirmed diagnosis of non-metastatic clear-cell renal cell carcinoma of intermediate to high risk with completely resectable primary tumours.
  • World Health Organization performance status of 0-1.
  • Adequate coagulation function as defined in protocol
  • Adequate hematological function as defined in protocol
  • Adequate hepatic function as defined in protocol
  • Adequate renal function as defined in protocol
  • Negative serum pregnancy test at screening for women of childbearing potential.
  • Highly effective contraception for both male and female subjects if the risk of conception exists.

Exclusion Criteria:

  • Renal tumors of low risk or M1
  • Non-clear cell histology at biopsy
  • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
  • Corrected QT interval (QTc) > 480 msecs
  • History of any of the cardiovascular conditions defined in the protocol within the past 6 months
  • Poorly controlled hypertension
  • History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
  • Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer
  • Evidence of active bleeding or bleeding diathesis.
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures.
  • Unable or unwilling to discontinue use of prohibited medications to be listed in protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
  • Treatment with any of the following anti-cancer therapies: chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of axitinib or avelumab
  • Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment
  • Prior organ transplantation, including allogeneic stem cell transplantation
  • Significant acute or chronic infections as defined in protocol
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Known severe hypersensitivity reactions to monoclonal antibodies
  • Pregnancy or lactation
  • Known alcohol or drug abuse


  • Axel Bex, MD
  • 003120512 Ext. 9111


  • Antoni van Leeuwenhoek
  • Amsterdam 1066CX Netherlands

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