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A Study of Avelumab With Axit...

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

Last Updated: 2025-07-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

886 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-23

Study Completion Date

2024-06-26

Brief Summary

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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

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Detailed Description

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Conditions

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Renal Cell Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Avelumab in combination with axitinib

Avelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID.

Group Type EXPERIMENTAL

Avelumab (MSB0010718C)

Intervention Type DRUG

IV treatment Avelumab administered at 10 mg/kg IV every two weeks

Axitinib (AG-013736)

Intervention Type DRUG

Oral treatment Axitinib given 5 mg PO BID

Sunitinib

Sunitinib given at 50 mg PO QD on schedule 4/2

Group Type ACTIVE_COMPARATOR

Sunitinib

Intervention Type DRUG

Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2

Interventions

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Avelumab (MSB0010718C)

IV treatment Avelumab administered at 10 mg/kg IV every two weeks

Intervention Type DRUG

Axitinib (AG-013736)

Oral treatment Axitinib given 5 mg PO BID

Intervention Type DRUG

Sunitinib

Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2

Intervention Type DRUG

Other Intervention Names

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Inlyta Sutent

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Southern Cancer Center

Daphne, Alabama, United States

Site Status

Southern Cancer Center

Mobile, Alabama, United States

Site Status

Southern Cancer Center

Mobile, Alabama, United States

Site Status

Tower Hematology Oncology Medical Group

Beverly Hills, California, United States

Site Status

City of Hope National Medical Center

Duarte, California, United States

Site Status

City of Hope

Duarte, California, United States

Site Status

Keck Hospital of USC

Los Angeles, California, United States

Site Status

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status

USC IDS Pharmacy

Los Angeles, California, United States

Site Status

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Cedars-Sinai Advanced Health Sciences Pavilion

Los Angeles, California, United States

Site Status

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States

Site Status

Cedars-Sinai

Los Angeles, California, United States

Site Status

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

Site Status

University of Colorado Cancer Center Anschutz Cancer Pavilion

Aurora, Colorado, United States

Site Status

University of Colorado Hospital - Clinical Trials Office (CTO)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Colorado Springs, Colorado, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Investigational Drug Service- Emory University

Atlanta, Georgia, United States

Site Status

The Emory Clinic

Atlanta, Georgia, United States

Site Status

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Site Status

East Jefferson General Hospital

Metairie, Louisiana, United States

Site Status

East Jefferson Hematology-Oncology Metairie Physician Service Inc.

Metairie, Louisiana, United States

Site Status

New England Cancer Specialists

Kennebunk, Maine, United States

Site Status

New England Cancer Specialists

Scarborough, Maine, United States

Site Status

New England Cancer Specialists

Topsham, Maine, United States

Site Status

Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status