Clinical trial NCT02684006: A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Cell Cancer
Keywords: Cancer
renal cell cancer
kidney disease
kidney neoplasms
axitinib, sunitinib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-02-17
Enrollment: 886
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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)

Primary outcomes:
measure: Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants
timeFrame: From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
measure: Overall Survival (OS) in PD-L1 Positive Participants
timeFrame: From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)
Secondary outcomes:
measure: PFS as Assessed by BICR in Participants Irrespective of PD-L1 Expression
timeFrame: From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
measure: OS in Participants Irrespective of PD-L1 Expression
timeFrame: From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)
measure: Percentage of Participants With Objective Response (OR) as Assessed by BICR Irrespective of PD-L1 Expression
timeFrame: From date of randomization until PD (maximum up to approximately 26 months)
measure: Percentage of Participants With OR as Assessed by Investigator Irrespective of PD-L1 Expression
timeFrame: From date of randomization until PD (maximum up to approximately 89 months)
measure: Percentage of Participants With Disease Control (DC) as Assessed by BICR Irrespective of PD-L1 Expression
timeFrame: From date of randomization until PD (maximum up to approximately 26 months)
measure: Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression
timeFrame: From date of randomization until PD (maximum up to approximately 89 months)
measure: Time to Tumor Response (TTR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression
timeFrame: From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)
measure: TTR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression
timeFrame: From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 89 months)
measure: Duration of Response (DR) as Assessed by BICR in Participants Irrespective of PD-L1 Expression
timeFrame: From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months)
measure: DR as Assessed by Investigator in Participants Irrespective of PD-L1 Expression
timeFrame: From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 89 months)
measure: PFS as Assessed by Investigator in Participants Irrespective of PD-L1 Expression
timeFrame: From date of randomization until PD, whichever occurred first (maximum up to approximately 89 months)
measure: Progression-Free Survival on Next-line Therapy (PFS2) in Participants Irrespective of PD-L1 Expression
timeFrame: From date of randomization until PD or death, whichever occurred first (maximum up to approximately 89 months)
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Version (V) 4.03
timeFrame: From first dose of study drug to 90 days after last administration of study drug
measure: Number of Participants With Laboratory Abnormalities Based on NCI-CTCAE V4.03
timeFrame: From first dose of study drug to 90 days after last administration of study drug
measure: Number of Participants With Vital Signs Abnormalities
timeFrame: From first dose of study drug to 90 days after last administration of study drug
measure: Time to Treatment Discontinuation/Failure Due to Toxicity
timeFrame: From first dose of study treatment until discontinuation of study treatment
measure: Number of Participants Who Discontinued Treatment Due to Toxicity
timeFrame: From first dose of study treatment until discontinuation of study treatment
measure: Trough Plasma Concentration (Ctrough) of Avelumab
timeFrame: Pre dose (0 hour) on Day 1, 15 and 29 of Cycle 1, Day 1 and 29 of Cycles 2, 3, 4 and Day 1 of Cycle 6
measure: Ctrough of Axitinib
timeFrame: Pre dose (0 hour) on day 15 and 29 of cycle 1 (each cycle= 6 weeks)
measure: Maximum Plasma Concentration (Cmax) of Axitinib
timeFrame: 2 hours post-dose on Day 1, pre-dose and 2 hours post dose on Days 15 and 29 of Cycle 1
measure: Number of Participants With Positive PD-L1 Biomarker Expression in Pre-treatment Tumor Tissue
timeFrame: At screening
measure: PFS in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups
timeFrame: From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)
measure: Percentage of Participants With OR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups
timeFrame: From date of randomization until PD (maximum up to approximately 26 months)
measure: Percentage of Participants With DC in Biomarker-Positive Subgroup
timeFrame: From date of randomization until PD or death, whichever occurred first (maximum up to approximately 26 months)
measure: TTR in Biomarker-Positive Subgroup
timeFrame: From the date of randomization to the first documentation of objective response (CR or PR) (maximum up to approximately 26 months)
measure: DR in PD-L1 Biomarker-Positive and PD-L1 Biomarker-Negative Subgroups
timeFrame: From documentation of OR until date of first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 26 months)
measure: Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) of Avelumab When Used in Combination With Axitinib
timeFrame: From start of treatment until 30 days after the end of avelumab treatment (maximum up to approximately 89 months)
measure: Time to Symptom Deterioration (TTD) for Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS)
timeFrame: Date of randomization to the first time the participant's score showed a 3-point or greater decrease in FKSI-DRS (maximum up to approximately 26 months)
measure: Change From Baseline in European Quality of Life (EuroQol) 5-Dimension 5 Levels (EQ-5D-5L) Utility Score
timeFrame: Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months)
measure: Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Score
timeFrame: Baseline, Day 1 of Cycle 2 to Cycle 60, End of treatment (any Day from Day 1 of dosing; maximum up to approximately 89 months)
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center
state: Alabama
city: Beverly Hills
country: United States
facility: Tower Hematology Oncology Medical Group
state: California
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: LAC + USC Medical Center
state: California
city: Los Angeles
country: United States
facility: Los Angeles General Medical Center
state: California
city: Los Angeles
country: United States
facility: USC IDS Pharmacy
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Advanced Health Sciences Pavilion
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Aurora
country: United States
facility: Anschutz Cancer Center Pavilion Pharmacy
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Cancer Center Anschutz Cancer Pavilion
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital - Clinical Trials Office (CTO)
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Investigational Drug Service- Emory University
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: Metairie
country: United States
facility: East Jefferson Hematology-Oncology Metairie Physician Service Inc.
state: Louisiana
city: Kennebunk
country: United States
facility: New England Cancer Specialists
state: Maine
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Topsham
country: United States
facility: New England Cancer Specialists
state: Maine
city: Baltimore
country: United States
facility: Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: John Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Brandywine
country: United States
facility: MedStar Health Cardiology Associates, LLC.
state: Maryland
city: Chester
country: United States
facility: Cardiology Associates, P.C.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital (MGH)
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital Clinical Trials Pharmacy
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (BIDMC)
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center Pharmacy - BIDMC
state: Massachusetts
city: Boston
country: United States
facility: Dana - Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Greenfield
country: United States
facility: Baystate Franklin Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Creve Coeur
country: United States
facility: Barnes-Jewish Hospital, Siteman Cancer Center - West County
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital, Siteman Cancer Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University Infusion Center Pharmacy
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital, Siteman Cancer Center - South County
state: Missouri
city: Saint Peters
country: United States
facility: Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters
state: Missouri
city: Billings
country: United States
facility: St. Vincent HealthCare
state: Montana
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Albany
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: Clifton Park
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Long Island City
country: United States
facility: Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
state: New York
city: New York
country: United States
facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone
state: New York
city: New York
country: United States
facility: NYU Investigational Pharmacy
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: MSKCC-Monitoring Suite
state: New York
city: New York
country: United States
facility: Evelyn H. Lauder Breast and Imaging Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Sidney Kimmel Center for Prostate and Urologic Cancers
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University-Cancer Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Kernersville
country: United States
facility: Novant Health Oncology Specialists
state: North Carolina
city: Lexington
country: United States
facility: Novant Health Oncology Specialists
state: North Carolina
city: Mount Airy
country: United States
facility: Novant Health Oncology Specialists
state: North Carolina
city: North Wilkesboro
country: United States
facility: Novant Health Oncology Specialists
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Clinical Research Onocolgy
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Oncology Specialists
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health Winston Salem Health Care
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Investigational Pharmacy
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: James Cancer Hospital and Solove Research Institute
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University - GU Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Allentown
country: United States
facility: Cancer Care Associates Medical Oncology
state: Pennsylvania
city: Allentown
country: United States
facility: St.Luke's Hospital-Allentown Campus
state: Pennsylvania
city: Bethlehem
country: United States
facility: Cancer Care Associate Medical Oncology
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Lukes University Health Network
state: Pennsylvania
city: Bethlehem
country: United States
facility: St.Luke's University Health Network
state: Pennsylvania
city: Easton
country: United States
facility: St.Luke's Cancer Center Anderson
state: Pennsylvania
city: Easton
country: United States
facility: St.Luke's Hospital-Anderson Campus
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Drug Service, University of Pennsylvania
state: Pennsylvania
city: Quakertown
country: United States
facility: St.Luke's Quakertown Hospital
state: Pennsylvania
city: York
country: United States
facility: Memorial Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Henry-Joyce Cancer Clinic
state: Tennessee
city: Nashville
country: United States
facility: Oncology IDS Pharmacy
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Oncology Pharmacy
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: Texas Oncology - Gulf Coast
state: Texas
city: Houston
country: United States
facility: Texas Oncology- Memorial City
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: Investigational Product Center (IPC)
state: Texas
city: Irving
country: United States
facility: Investigational Products Center (IPC)
state: Texas
city: Irving
country: United States
facility: Investigational Products Center (lPC)
state: Texas
city: Irving
country: United States
facility: US Oncology Investigational Products Center (IPC)
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Puyallup
country: United States
facility: Rainier Hematology-Oncology, PC
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance / University of Washington
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Macquarie University
country: Australia
facility: Macquarie University Hospital Pharmacy
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University
state: New South Wales
city: Randwick
country: Australia
facility: Nuclear Medicine Department
state: New South Wales
city: Randwick
country: Australia
facility: Pharmacy Department, Clinical Trials
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Spectrum Medical Imaging
state: New South Wales
city: Woolloongabba
country: Australia
facility: Division of Cancer Services
state: Queensland
city: Ballarat
country: Australia
facility: BHS Diagnostic Services
state: Victoria
city: Ballarat
country: Australia
facility: Lake Imaging
state: Victoria
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Box Hill
country: Australia
facility: Eastern Health
state: Victoria
city: Clayton
country: Australia
facility: Monash Health Translational Precinct, Monash Medical Centre
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: East Bentleigh
country: Australia
facility: Monash Cancer Centre
state: Victoria
city: East Bentleigh
country: Australia
facility: Moorabbin Radiology
state: Victoria
city: Mount Waverley
country: Australia
facility: Slade Health
state: Victoria
city: Wendouree
country: Australia
facility: Ballarat Day Procedure Centre
state: Victoria
city: Wendouree
country: Australia
facility: Ballarat Oncology & Haematology Services
state: Victoria
city: Wendouree
country: Australia
facility: Nova Pharmacy
state: Victoria
city: Murdoch
country: Australia
facility: SKG Radiology
state: Western Australia
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Murdoch
country: Australia
facility: SKG Radiology
state: Western Australia
city: Murdoch
country: Australia
facility: St John of God Murdoch Hospital
state: Western Australia
city: Perth
country: Australia
facility: EPIC Pharmacy Murdoch
state: Western Australia
city: Wien
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Wien
city: Wien
country: Austria
facility: Medizinische Universitaet Wien
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Liège
country: Belgium
facility: CHU de Liège
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency - Kelowna
state: British Columbia
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer GU Clinic - Fairmont Medical Building
state: British Columbia
city: London
country: Canada
facility: London Regional Cancer Program, London Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program, London Health Sciences Centre
state: Ontario
city: Oshawa
country: Canada
facility: R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke
state: Quebec
city: Herlev
country: Denmark
facility: Herlev Hospital, Onkologisk Afdeling R
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Rennes
country: France
facility: Centre Eugene Marquis Service Pharmacie - Essais Cliniques
state: Cedex
city: CAEN cedex 05
country: France
facility: Centre FRANCOIS BACLESSE
city: Caen, Cedex 05
country: France
facility: Centre Francois Baclesse
city: Le Mans
country: France
facility: Centre de cancerologie de la Sarthe
city: Le Mans
country: France
facility: Centre de Cancérologie de la Sarthe (CCS) - Clinique Victor Hugo
city: Le Mans
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard
city: Le Mans
country: France
facility: Clinique Victor Hugo Centre de Cancerologie de la Sarthe
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lyon cedex 8
country: France
facility: Centre Léon Bérard
city: LYON cedex 8
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Rennes cedex
country: France
facility: Centre Eugene Marquis
city: Saint-Herblain Cedex
country: France
facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau
city: Vandoeuvre les Nancy
country: France
facility: Institut de Cancerologie de Lorraine (ICL)
city: Vandoeuvre les Nancy
country: France
facility: Institut de Cancerologie de Lorraine
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden-wuerttemberg
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden-wuerttemberg
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
state: Thuringia
city: Jena
country: Germany
facility: Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie
state: Thuringia
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
state: Thuringia
city: Budapest
country: Hungary
facility: Dél.pesti Centrumkórház-OHII Szent Lálszló Kórház telephely
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
state: Ramat - GAN
city: Beer Yaakov
country: Israel
facility: Assaf Harofe MC
city: Beer Yaakov
country: Israel
facility: Shamir Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: Rambam Healthcare Campus
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat - Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - IRCCS
state: (pn)
city: Rozzano
country: Italy
facility: Farmacia Studi Clinici
state: Milan
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
city: Milan
country: Italy
facility: SC Farmacia
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia
city: Milan
country: Italy
facility: Servizio di Farmacia
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Hirosaki
country: Japan
facility: Hirosaki University School of Medicine & Hospital
state: Aomori
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaidô
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine, University Hospital
state: Shizuoka
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Akita
country: Japan
facility: Akita University Hospital
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Goyang-si
country: Korea, Republic of
facility: Clinical Trial Pharmacy, National Cancer Center
state: Gyeonggi-do
city: Goyang-Si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital, Clinical Pharmacy
state: Gyeonggido
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggido
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center, Clinical Pharmacy
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital, Clinical Pharmacy
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Clinical Pharmacy
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Pharmacy
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center Clinical Trial Pharmacy
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Mexico
country: Mexico
facility: Instituto Nacional de Cancerologia
state: Ciudad DE Mexico
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer
state: Nuevo LEON
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C.
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital
state: Noord-holland
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute / Apotheek MC Slotervaart
state: Noord-holland
city: Amsterdam
country: Netherlands
facility: VU University Medical Center (VUmc)
state: Noord-holland
city: Amsterdam
country: Netherlands
facility: VU University Medical Center (VUmc)
state: Noord-holland
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis, Pharmacy
state: Zuid-holland
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis
state: Zuid-holland
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Haarlem
country: Netherlands
facility: St Apotheek der Haarlemse Ziekenhuizen
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Grafton
country: New Zealand
facility: Auckland City Hospital
state: Auckland
city: Tauranga
country: New Zealand
facility: Tauranga Hospital, Bay of Plenty Clinical Trials Unit
state: BAY OF Plenty
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital
state: Manawatu- Whanganui
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital
state: Manawatu-wanganui
city: Tauranga Bay Of Plenty
country: New Zealand
facility: Tauranga Hospital
state: Tauranga
city: Masterton
country: New Zealand
facility: Wairarapa District Health Board
state: Wairarapa
city: Auckland
country: New Zealand
facility: Auckland City Hospital Pharmacy
city: Auckland
country: New Zealand
facility: Baxter Healthcare New Zealand
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital Pharmacy Services
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Palmerston North
country: New Zealand
facility: Broadway Radiology
city: Cluj-Napoca
country: Romania
facility: "Prof. Dr. Ion Chiricuta" Oncology Institute
city: Cluj-Napoca
country: Romania
facility: S.C. Medisprof S.R.L.
city: Craiova
country: Romania
facility: "Sfantul Nectarie" Oncology Center
city: Timisoara
country: Romania
facility: Oncomed SRL
city: Kursk
country: Russian Federation
facility: RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address)
state: Kursk Region
city: Kursk
country: Russian Federation
facility: RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR
state: Kursk Region
city: Saint Petersburg
country: Russian Federation
facility: Russian Research Center for Radiology and Surgical Technologies
state: Pesochny
city: Saint-Petersburg
country: Russian Federation
facility: FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF
state: Poselok Pesochniy
city: Pushkin
country: Russian Federation
facility: Private medical institution "Euromedservice"
state: Saint-petersburg
city: Moscow
country: Russian Federation
facility: Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal
city: Moscow
country: Russian Federation
facility: Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen
city: Nizhniy Novgorod
country: Russian Federation
facility: FBIH "Privolzhskiy Regional Medical Center" of FMBA
city: Nizhniy Novgorod
country: Russian Federation
facility: SBIH of Nizhegorodskaya region "Clinical-Diagnostics center"
city: Nizhniy Novgorod
country: Russian Federation
facility: FBIH "Privolzhskiy Regional Medical Center" of FMBA
city: Nizhniy Novgorod
country: Russian Federation
facility: FBIH "Privolzhskiy Regional Medical Center" of FMBA
city: Nizhniy Novgorod
country: Russian Federation
facility: SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary"
city: Saint Petersburg
country: Russian Federation
facility: Clinical Hospital #122 n.a. L. G. Sokolov
city: Saint Petersburg
country: Russian Federation
facility: NS HI "Road Clinical Hospital of JSC "Russian Railways""
city: Saint Petersburg
country: Russian Federation
facility: LLC "Diagnostic center "Energo"
city: Yaroslavl
country: Russian Federation
facility: LLC "Clinical Diagnostic Center "Medex-pert"
city: Yaroslavl
country: Russian Federation
facility: SHI YR Regional Clinical Oncology Hospital
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital, Dept of Oncology
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital
state: Cambridgeshire
city: London
country: United Kingdom
facility: Mount Vernon Cancer Centre, East & North Herts NHS Trust
state: Middlesex
city: London
country: United Kingdom
facility: Mount Vernon Cancer Centre, Pharmacy
state: Middlesex
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey, London
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital, Central Pharmacy, Level 1
city: Glasgow
country: United Kingdom
facility: Beatson WOSCC
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,
city: London
country: United Kingdom
facility: St Bartholomew's Hospital, Barts Health NHS Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Clinical Trials Pharmacy, The Christie
city: Manchester
country: United Kingdom
facility: Department of Medical Oncology, The Christie NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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citation: Motzer RJ, Penkov K, Haanen J, Rini B, Albiges L, Campbell MT, Venugopal B, Kollmannsberger C, Negrier S, Uemura M, Lee JL, Vasiliev A, Miller WH Jr, Gurney H, Schmidinger M, Larkin J, Atkins MB, Bedke J, Alekseev B, Wang J, Mariani M, Robbins PB, Chudnovsky A, Fowst C, Hariharan S, Huang B, di Pietro A, Choueiri TK. Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019 Mar 21;380(12):1103-1115. doi: 10.1056/NEJMoa1816047. Epub 2019 Feb 16.