A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)

Completed · Phase 1

Conditions studied: Renal Cell Cancer

In brief

This is a Phase 1b, open-label, multi-center, multiple-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended phase 2 dose (RP2D) of avelumab (MSB0010718C) in combination with axitinib (AG-013736). Once the MTD of avelumab administered in combination with axitinib is estimated (dose finding portion), the dose expansion phase will be opened to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarker modulation.

Key facts

Study ID

NCT02493751

Run by

Pfizer

People needed

55

Starts

2015-10-26

Expected to finish

2021-03-04

Last updated by the study team

2022-02-18

Who can join

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

You may qualify if…

• Histologically or cytologically confirmed advanced RCC with clear cell component
• Primary tumor resected
• Availability of a recent 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 enrollment AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and enrollment onto the current study. If an FFPE tissue block cannot be provided as per documented regulations,, 15 unstained slides (10 minimum) will be acceptable.
• Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (if available and not provided per above). If an FFPE tissue block cannot be provided, 15 unstained slides (10 minimum) will be acceptable
• At least one measureable lesion as defined by RECIST version 1.1 that has not been previously irradiated.
• Age ≥18 years (≥ 20 years in Japan).
• 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 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 as well as any prior therapies with other VEGF pathway inhibitors.
• Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis.
• Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, 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

• Scottsdale Healthcare Hospitals d/b/a HonorHealth — Scottsdale, Arizona, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Laura & Isaac Perlmutter Cancer Center At NYU Langone — New York, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Henry Joyce Cancer Clinic — Nashville, Tennessee, United States
• University of Utah, Huntsman Cancer Hospital — Salt Lake City, Utah, United States
• University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Niigata University Medical & Dental Hospital — Chuo-ku, Niigata, Niigata, Japan
• Kindai University Hospital — Sayama, Osaka, Japan
• Keio University Hospital — Shinjuku-ku, Tokyo, Japan
• Mount Vernon Cancer Center, East and North Herts. NHS Trust — London, Middlesex, United Kingdom
• St Helier Hospital — Carshalton, Surrey, United Kingdom
• St. Bartholomew's Hospital — London, United Kingdom
• The Royal Marsden NHS Foundation Trust — London, United Kingdom
• The Christie NHS Foundation Trust — Manchester, United Kingdom
• The Royal Marsden NHS Foundation Trust — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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