Neoadjuvant AXITINIB and AVELUMAB for Patients With Localized Clear-cell RCC

• Status: Recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Collaborator: Pfizer
• Treatments: Antibodies, Monoclonal; Avelumab; Axitinib

Criteria

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