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

Completed · Phase 3

Conditions studied: Renal Cell Cancer

In brief

This is a phase 3 randomized trial evaluating the anti-tumor 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

Key facts

Study ID

NCT02684006

Run by

Pfizer

People needed

886

Starts

2016-03-23

Expected to finish

2024-06-26

Last updated by the study team

2025-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed advanced or metastatic RCC with clear cell component
• Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of randomization AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, 15 unstained slides (10 minimum) will be acceptable
• Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be provided as per documented regulations 15 unstained slides (10 minimum) will be acceptable
• At least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Adequate bone marrow function, renal and liver functions

You may not qualify if…

• Prior systemic therapy directed at advanced or metastatic RCC
• Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment.
• Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
• Prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors
• Newly diagnosed or active brain metastasis
• Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011)
• Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack
• Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism
• Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines)

Where it is running

• Southern Cancer Center — Mobile, Alabama, United States
• Southern Cancer Center — Mobile, Alabama, United States
• Tower Hematology Oncology Medical Group — Beverly Hills, California, United States
• City of Hope National Medical Center — Duarte, California, United States
• City of Hope — Duarte, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• Los Angeles General Medical Center — Los Angeles, California, United States
• USC IDS Pharmacy — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Cedars-Sinai Advanced Health Sciences Pavilion — Los Angeles, California, United States
• Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• Cedars-Sinai — Los Angeles, California, United States
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States
• University of Colorado Cancer Center Anschutz Cancer Pavilion — Aurora, Colorado, United States
• University of Colorado Hospital - Clinical Trials Office (CTO) — Aurora, Colorado, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Rocky Mountain Cancer Centers — Colorado Springs, Colorado, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Investigational Drug Service- Emory University — Atlanta, Georgia, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• East Jefferson General Hospital — Metairie, Louisiana, United States
• Southern Cancer Center — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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