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A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A PHASE 3, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, PARALLEL-ARM STUDY OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (INLYTA(REGISTERED)) VERSUS SUNITINIB (SUTENT(REGISTERED)) MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA

NCT02684006•Pfizer

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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)

Locations (270)

Southern Cancer Center

Daphne, Alabama, United States

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

Key Dates

Start Date

March 23, 2016

Primary Completion Date

August 31, 2023

Completion Date

June 26, 2024

Last Updated

July 30, 2025

Enrollment

886

ACTUAL participants

Conditions

Renal Cell Cancer

Interventions

Avelumab (MSB0010718C)

DRUG

Axitinib (AG-013736)

DRUG

Sunitinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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