Status:
UNKNOWN
Neoadjuvant AXITINIB and AVELUMAB for Patients With Localized Clear-cell RCC
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Pfizer
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Renal cell carcinoma (RCC) accounts for 3% of adult malignancies and constitutes 95% of renal tumors. Surgical complete resection is currently the only curative treatment of RCC, including patients wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03341845
Start Date
March 28 2018
End Date
January 31 2025
Last Update
May 21 2018
Active Locations (1)
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1
Antoni van Leeuwenhoek
Amsterdam, Netherlands, 1066CX