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

NCT03341845 | Unknown Phase 2

• 1 other identifier: N17JAV
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• number of patients with partial remission

  according to RECIST 1.1.

  week 12 of neoadjuvant treatment

Secondary Outcomes (2)

• toxicity

  up to 90 days after end of treatment

• event free survival and overall survival

  assessed up to 10 years

Study Arms (1)

axitinib and avelumab

EXPERIMENTAL

axitinib 5MG BID and avelumab 10mg/kg Q2W

Drug: Axitinib; Drug: Avelumab

Interventions

Axitinib DRUG

axitinib in combination with avelumab

axitinib and avelumab

Avelumab DRUG

axitinib in combination with avelumab

axitinib and avelumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Pfizer: collaborator

Study Sites (1)

Antoni van Leeuwenhoek

Amsterdam, 1066CX, Netherlands

RECRUITING

Related Publications (1)

• Bex A, van Thienen JV, Schrier M, Graafland N, Kuusk T, Hendricksen K, Lagerveld B, Zondervan P, van Moorselaar JA, Blank C, Wilgenhof S, Haanen J. A Phase II, single-arm trial of neoadjuvant axitinib plus avelumab in patients with localized renal cell carcinoma who are at high risk of relapse after nephrectomy (NEOAVAX). Future Oncol. 2019 Jul;15(19):2203-2209. doi: 10.2217/fon-2019-0111. Epub 2019 Apr 26.

  PMID: 31023100 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Axitinib; avelumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Axel Bex, MD

  NKI-AvL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Bex, MD

CONTACT

003120512; a.bex@nki.nl

Hans van Thienen, MD

CONTACT

003120512; h.v.thienen@nki.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: simon's two stage design

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 14, 2017
• Study Start: March 28, 2018
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2025
• Last Updated: May 21, 2018

Record last verified: 2018-04

Locations

NL (1)