Back to resultsA Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Primary Purpose
Renal Cell Cancer
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Avelumab (MSB0010718C)
Axitinib (AG-013736)
Sunitinib
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Cancer focused on measuring Cancer, renal cell cancer, kidney disease, kidney neoplasms, axitinib, sunitinib
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 providedas per documented regulations 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
- 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 dignosed 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)
Sites / Locations
- Southern Cancer Center
- Southern Cancer Center
- Southern Cancer Center
- Tower Hematology Oncology Medical Group
- City of Hope National Medical Center
- City of Hope
- Keck Hospital of USC
- LAC + USC Medical Center
- USC IDS Pharmacy
- USC/Norris Comprehensive Cancer Center
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
- Cedars-Sinai
- Anschutz Cancer Center Pavilion Pharmacy
- University of Colorado Cancer Center Anschutz Cancer Pavilion
- Rocky Mountain Cancer Centers
- Georgetown University Medical Center
- Moffitt Cancer Center and Research Institute
- Emory University Hospital
- Investigational Drug Service- Emory University
- The Emory Clinic
- Winship Cancer Institute, Emory University
- East Jefferson General Hospital
- East Jefferson Hematology-Oncology Metairie Physician Service Inc.
- New England Cancer Specialists
- New England Cancer Specialists
- New England Cancer Specialists
- Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital
- The Sidney Kimmel Comprehensive Cancer Center
- Johns Hopkins Hospital
- MedStar Health Cardiology Associates, LLC.
- Cardiology Associates, P.C.
- Massachusetts General Hospital (MGH)
- Massachusetts General Hospital Clinical Trials Pharmacy
- Brigham & Women's Hospital
- Beth Israel Deaconess Medical Center (BIDMC)
- Beth Israel Deaconess Medical Center Pharmacy - BIDMC
- Dana-Farber Cancer Institute
- Baystate Franklin Medical Center
- Mayo Clinic
- Barnes-Jewish Hospital, Siteman Cancer Center - West County
- Barnes-Jewish Hospital, Siteman Cancer Center
- Washington University Infusion Center Pharmacy
- Washington University School of Medicine
- Barnes-Jewish Hospital, Siteman Cancer Center - South County
- Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters
- St. Vincent HealthCare
- St. Vincent Frontier Cancer Center
- Comprehensive Cancer Centers of Nevada
- Comprehensive Cancer Centers of Nevada
- Comprehensive Cancer Centers of Nevada
- New York Oncology Hematology, P.C.
- New York Oncology Hematology, PC
- New York Oncology Hematology, P.C.
- Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
- Laura & Isaac Perlmutter Cancer Center at NYU Langone
- NYU Investigational Pharmacy
- NYU Langone Medical Center
- MSKCC-Monitoring Suite
- Memorial Sloan Kettering Cancer Center
- Sidney Kimmel Center for Prostate and Urologic Cancers
- Stony Brook University
- Stony Brook University-Cancer Center
- Stony Brook University
- Novant Health Oncology Specialists
- Novant Health Oncology Specialists
- Novant Health Oncology Specialists
- Novant Health Oncology Specialists
- Novant Health Clinical Research Onocolgy
- Novant Health Oncology Specialists
- Novant Health Winston Salem Health Care
- Cleveland Clinic Investigational Pharmacy
- Cleveland Clinic
- James Cancer Hospital and Solove Research Institute
- The Ohio State University - GU Clinic
- The Ohio State University
- Cancer Care Associates Medical Oncology
- St.Luke's Hospital-Allentown Campus
- Cancer Care Associate Medical Oncology
- St.Luke's University Health Network
- St.Luke's Cancer Center Anderson
- St.Luke's Hospital-Anderson Campus
- Hospital of the University of Pennsylvania
- Investigational Drug Service, University of Pennsylvania
- St.Luke's Quakertown Hospital
- Memorial Hospital
- Vanderbilt-Ingram Cancer Center
- Henry-Joyce Cancer Clinic
- Vanderbilt University Oncology Pharmacy
- Texas Oncology - Baylor Charles A. Sammons Cancer Center
- Texas Oncology- Memorial City
- The University of Texas MD Anderson Cancer Center
- Investigational Product Center (IPC)
- Investigational Products Center (IPC)
- Investigational Products Center (lPC)
- US Oncology Investigational Products Center (IPC)
- Joe Arrington Cancer Research and Treatment Center
- Rainier Hematology-Oncology, PC
- Seattle Cancer Care Alliance / University of Washington
- Seattle Cancer Care Alliance
- University of Washington Medical Center
- Northwest Medical Specialties, PLLC
- Macquarie University Hospital Pharmacy
- Macquarie University
- Nuclear Medicine Department
- Pharmacy Department, Clinical Trials
- Prince of Wales Hospital
- Spectrum Medical Imaging
- Division of Cancer Services
- BHS Diagnostic Services
- Lake Imaging
- Box Hill Hospital
- Eastern Health
- Monash Health Translational Precinct, Monash Medical Centre
- Monash Medical Centre
- Monash Cancer Centre
- Moorabbin Radiology
- Slade Health
- Ballarat Day Procedure Centre
- Ballarat Oncology & Haematology Services
- Nova Pharmacy
- SKG Radiology
- Fiona Stanley Hospital
- SKG Radiology
- St John of God Murdoch Hospital
- EPIC Pharmacy Murdoch
- Krankenhaus der Barmherzigen Schwestern Wien
- Medizinische Universitaet Wien
- Cliniques Universitaires Saint-Luc
- Cliniques Universitaires Saint-Luc
- UZ Gent
- AZ Groeninge
- CHU de Liège
- Foothills Medical Centre
- Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
- Cross Cancer Institute
- British Columbia Cancer Agency - Kelowna
- British Columbia Cancer Agency
- BC Cancer GU Clinic - Fairmont Medical Building
- London Regional Cancer Program, London Health Sciences Centre
- London Regional Cancer Program, London Health Sciences Centre
- R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health
- Sunnybrook Research Institute
- Jewish General Hospital
- CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke
- Herlev Hospital, Onkologisk Afdeling R
- Odense Universitetshospital
- Centre Eugene Marquis Service Pharmacie - Essais Cliniques
- Centre FRANCOIS BACLESSE
- Centre Francois Baclesse
- Centre de cancerologie de la Sarthe
- Centre de Cancérologie de la Sarthe (CCS) - Clinique Victor Hugo
- Clinique Victor Hugo - Centre Jean Bernard
- Clinique Victor Hugo Centre de Cancerologie de la Sarthe
- Clinique Victor Hugo
- Centre Léon Bérard
- Centre Léon Bérard
- Institut Paoli Calmettes
- Centre Eugene Marquis
- Institut de Cancérologie de l'Ouest - Centre René Gauducheau
- Institut de Cancerologie de Lorraine (ICL)
- Institut de Cancerologie de Lorraine
- Institut Gustave Roussy
- Universitaetsklinikum Tuebingen
- Universitaetsklinikum Tuebingen
- Universitaetsklinikum Jena
- Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie
- Universitaetsklinikum Jena
- Dél.pesti Centrumkórház-OHII Szent Lálszló Kórház telephely
- Országos Onkológiai Intézet
- The Chaim Sheba Medical Center
- Assaf Harofe MC
- Shamir Medical Center
- Rambam Health Care Campus
- Rambam Healthcare Campus
- Meir Medical Center
- Rabin Medical Center
- The Chaim Sheba Medical Center
- Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center
- Tel Aviv Sourasky Medical Center
- Centro di Riferimento Oncologico - IRCCS
- Farmacia Studi Clinici
- Istituto Clinico Humanitas
- Fondazione IRCCS Istituto Nazionale dei Tumori
- SC Farmacia
- Istituto Europeo di Oncologia
- Servizio di Farmacia
- Azienda Ospedaliera San Camillo Forlanini
- Nagoya University Hospital
- Hirosaki University School of Medicine & Hospital
- Hokkaido University Hospital
- Iwate Medical University Hospital
- Yokohama City University Hospital
- Kindai University Hospital
- Osaka University Hospital
- Hamamatsu University School of Medicine, University Hospital
- Keio University Hospital
- Tokyo Women's Medical University Hospital
- Akita University Hospital
- Chiba Cancer Center
- Kyushu University Hospital
- Niigata University Medical & Dental Hospital
- Tokushima University Hospital
- Yamagata University Hospital
- Clinical Trial Pharmacy, National Cancer Center
- National Cancer Center
- Seoul National University Bundang Hospital, Clinical Pharmacy
- Seoul National University Bundang Hospital
- Kyungpook National University Medical Center, Clinical Pharmacy
- Kyungpook National University Medical Center
- Chungnam National University Hospital, Clinical Pharmacy
- Chungnam National University Hospital
- Seoul National University Hospital, Clinical Pharmacy
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- Asan Medical Center
- Clinical Trial Pharmacy
- Samsung Medical Center Clinical Trial Pharmacy
- Samsung Medical Center
- Instituto Nacional de Cancerologia
- Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer
- Oaxaca Site Management Organization S.C.
- Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital
- Netherlands Cancer Institute / Apotheek MC Slotervaart
- VU University Medical Center (VUmc)
- VU University Medical Center (VUmc)
- Sint Franciscus Gasthuis, Pharmacy
- Sint Franciscus Gasthuis
- Maxima Medisch Centrum
- St Apotheek der Haarlemse Ziekenhuizen
- Spaarne Gasthuis
- Maastricht University Medical Center
- Maxima Medisch Centrum
- Maxima Medisch Centrum
- Auckland City Hospital
- Tauranga Hospital, Bay of Plenty Clinical Trials Unit
- Palmerston North Hospital
- Tauranga Hospital
- Wairarapa District Health Board
- Auckland City Hospital Pharmacy
- Baxter Healthcare New Zealand
- Christchurch Hospital
- Waikato Hospital Pharmacy Services
- Waikato Hospital
- Broadway Radiology
- "Prof. Dr. Ion Chiricuta" Oncology Institute
- S.C. Medisprof S.R.L.
- "Sfantul Nectarie" Oncology Center
- Oncomed SRL
- RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address)
- RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR
- Russian Research Center for Radiology and Surgical Technologies
- FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF
- Private medical institution "Euromedservice"
- Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal
- Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen
- FBIH "Privolzhskiy Regional Medical Center" of FMBA
- SBIH of Nizhegorodskaya region "Clinical-Diagnostics center"
- FBIH "Privolzhskiy Regional Medical Center" of FMBA
- FBIH "Privolzhskiy Regional Medical Center" of FMBA
- SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary"
- Clinical Hospital #122 n.a. L. G. Sokolov
- NS HI "Road Clinical Hospital of JSC "Russian Railways""
- LLC "Diagnostic center "Energo"
- LLC "Clinical Diagnostic Center "Medex-pert"
- SHI YR Regional Clinical Oncology Hospital
- Clinica Universidad de Navarra
- Hospital Universitario Ramon y Cajal
- Hospital Universitario Virgen del Rocio
- Sahlgrenska University Hospital, Dept of Oncology
- Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital
- Mount Vernon Cancer Centre, East & North Herts NHS Trust
- Mount Vernon Cancer Centre, Pharmacy
- The Royal Marsden NHS Foundation Trust
- The Royal Marsden NHS Foundation Trust
- Addenbrooke's Hospital, Central Pharmacy, Level 1
- Beatson WOSCC
- Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,
- St Bartholomew's Hospital, Barts Health NHS Trust
- The Royal Marsden NHS Foundation Trust
- Clinical Trials Pharmacy, The Christie
- Department of Medical Oncology, The Christie NHS Foundation Trust
- Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus
- Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Avelumab in combination with axitinib
Sunitinib
Arm Description
Avelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID.
Sunitinib given at 50 mg PO QD on schedule 4/2
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS) in PD-L1 positive patients
Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by BICR (by RECIST version 1.1) or death due to any cause.
Overall Survival in PD-L1 positive patients
OS is the time from date of randomization to date of death due to any cause.
Secondary Outcome Measures
Overall Survival (OS) in unselected patients
OS is the time from date of randomization to date of death due to any cause.
Number of participants with Objective Response (OR)
Number of participants with objective response (ie, confirmed complete or partial response according to RECIST Version 1.1 recorded from randomization until disease progression assessed by BICR or death due to any cause)
Disease Control (DC)
DC is defined as complete response (CR), partial response (PR), or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression assessed by BICR or death due to any cause.
Time to Tumor Response (TTR)
TRR is the time from randomization to first documentation of objective tumor response (CR or PR).
Duration of response (DR)
DR is the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression assessed by BICR or death due to any cause
Progression Free Survival (PFS) by Investigator assessment
Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by the Investigator (by RECIST version 1.1) or death due to any cause.
Trough plasma concentration (Ctrough) of avelumab
Ctrough is defined as the concentration at the end of avelumab dosage interval
Trough plasma concentration (Ctrough) of axitinib
Ctrough is defined as the concentration at the end of axitinib dosage interval
Maximum plasma concentration (Cmax) of axitinib
Cmax defined as the maximum plasma concentration of axitinib
Anti-Drug Antibody (ADA) levels of avelumab/Neutralizing antibodies titers for MSB0010718C
Immunogenicity assessment of avelumab
Tumor tissue biomarker status
Biomarker status defined as positive or negative based on a pre-specified scoring algorithm involving, for example, PD-L1 expression and/or quantitation of tumor infiltrating CD8+T lymphocytes as assessed by IHC
Overall Survival (OS) in biomarker-positive and biomarker-negative subgroups
OS in biomarker-negative and biomarker-positive subgroups.
Change From Baseline in FACT-Kidney Symptom Index (FKSI)-19
The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains- Disease Related Symptoms (physical and emotional), Treatment related side effects and Functional and Well-Being . A negative change from Baseline represents a worsening of condition.
Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Health State Profile
EQ-5D Health State Profile: participant rated questionnaire to assess health-related quality of life in terms of a single index value.
Progression Free Survival (PFS) in biomarker-positive and biomarker-negative subgroups
PFS as measure of clinical outcome in biomarker-negative and biomarker-positive subgroups.
Objective Response (OR) in biomarker-positive and biomarker-negative subgroups
OR in biomarker-negative and biomarker-positive subgroups
Disease Control (DC) in biomarker-positive and biomarker-negative subgroups
DC in biomarker-negative and biomarker-positive subgroups
Time To Response (TTR) in biomarker-positive and biomarker-negative subgroups
TTR in biomarker-negative and biomarker-positive subgroups.
Duration of Response (DR) in biomarker-positive and biomarker-negative subgroups
DR in biomarker-negative and biomarker-positive subgroups.
Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Visual Analogic Scale
EQ-5D Visual Analogic Scale:patients rated their overall health status from 0 (worst imaginable heath state) to 100 (best imaginable heath state).
Time to treatment discontinuation/failure due to toxicity (TTF)
TTF is defined as the time from Cycle 1 Day 1 to the date of the first documentation of discontinuation due to an adverse event or death due to study treatment toxicity
Treatment discontinuation/failure due to toxicity
Treatment discontinuation is the percentage of patients who discontinue the treatment due to an adverse event or death due to study treatment toxicity
PFS on next-line therapy (PFS2)
PFS2 is defined as the time from randomization to discontinuation of next line treatment, second objective disease progression, or death from any cause, whichever occurs first.
Progression Free Survival (PFS) in unselected patients
Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by BICR (by RECIST version 1.1) or death due to any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02684006
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 23, 2016 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
May 21, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Cancer
Keywords
Cancer, renal cell cancer, kidney disease, kidney neoplasms, axitinib, sunitinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
888 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Avelumab in combination with axitinib
Arm Type
Experimental
Arm Description
Avelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID.
Arm Title
Sunitinib
Arm Type
Active Comparator
Arm Description
Sunitinib given at 50 mg PO QD on schedule 4/2
Intervention Type
Drug
Intervention Name(s)
Avelumab (MSB0010718C)
Intervention Description
IV treatment Avelumab administered at 10 mg/kg IV every two weeks
Intervention Type
Drug
Intervention Name(s)
Axitinib (AG-013736)
Other Intervention Name(s)
Inlyta
Intervention Description
Oral treatment Axitinib given 5 mg PO BID
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sutent
Intervention Description
Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) in PD-L1 positive patients
Description
Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by BICR (by RECIST version 1.1) or death due to any cause.
Time Frame
From randomization up to 40 months.
Title
Overall Survival in PD-L1 positive patients
Description
OS is the time from date of randomization to date of death due to any cause.
Time Frame
Every 3 months up to 8 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS) in unselected patients
Description
OS is the time from date of randomization to date of death due to any cause.
Time Frame
Every 3 months up to 8 years
Title
Number of participants with Objective Response (OR)
Description
Number of participants with objective response (ie, confirmed complete or partial response according to RECIST Version 1.1 recorded from randomization until disease progression assessed by BICR or death due to any cause)
Time Frame
Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Title
Disease Control (DC)
Description
DC is defined as complete response (CR), partial response (PR), or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression assessed by BICR or death due to any cause.
Time Frame
Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Title
Time to Tumor Response (TTR)
Description
TRR is the time from randomization to first documentation of objective tumor response (CR or PR).
Time Frame
Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Title
Duration of response (DR)
Description
DR is the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression assessed by BICR or death due to any cause
Time Frame
Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Title
Progression Free Survival (PFS) by Investigator assessment
Description
Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by the Investigator (by RECIST version 1.1) or death due to any cause.
Time Frame
Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Title
Trough plasma concentration (Ctrough) of avelumab
Description
Ctrough is defined as the concentration at the end of avelumab dosage interval
Time Frame
Pre-dose
Title
Trough plasma concentration (Ctrough) of axitinib
Description
Ctrough is defined as the concentration at the end of axitinib dosage interval
Time Frame
Pre-dose
Title
Maximum plasma concentration (Cmax) of axitinib
Description
Cmax defined as the maximum plasma concentration of axitinib
Time Frame
2 hours post-dose
Title
Anti-Drug Antibody (ADA) levels of avelumab/Neutralizing antibodies titers for MSB0010718C
Description
Immunogenicity assessment of avelumab
Time Frame
Pre-dose
Title
Tumor tissue biomarker status
Description
Biomarker status defined as positive or negative based on a pre-specified scoring algorithm involving, for example, PD-L1 expression and/or quantitation of tumor infiltrating CD8+T lymphocytes as assessed by IHC
Time Frame
Baseline
Title
Overall Survival (OS) in biomarker-positive and biomarker-negative subgroups
Description
OS in biomarker-negative and biomarker-positive subgroups.
Time Frame
Baseline
Title
Change From Baseline in FACT-Kidney Symptom Index (FKSI)-19
Description
The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains- Disease Related Symptoms (physical and emotional), Treatment related side effects and Functional and Well-Being . A negative change from Baseline represents a worsening of condition.
Time Frame
Every 6 weeks up to 8 years
Title
Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Health State Profile
Description
EQ-5D Health State Profile: participant rated questionnaire to assess health-related quality of life in terms of a single index value.
Time Frame
Every 6 weeks up to 8 years
Title
Progression Free Survival (PFS) in biomarker-positive and biomarker-negative subgroups
Description
PFS as measure of clinical outcome in biomarker-negative and biomarker-positive subgroups.
Time Frame
Baseline
Title
Objective Response (OR) in biomarker-positive and biomarker-negative subgroups
Description
OR in biomarker-negative and biomarker-positive subgroups
Time Frame
Baseline
Title
Disease Control (DC) in biomarker-positive and biomarker-negative subgroups
Description
DC in biomarker-negative and biomarker-positive subgroups
Time Frame
Baseline
Title
Time To Response (TTR) in biomarker-positive and biomarker-negative subgroups
Description
TTR in biomarker-negative and biomarker-positive subgroups.
Time Frame
Baseline
Title
Duration of Response (DR) in biomarker-positive and biomarker-negative subgroups
Description
DR in biomarker-negative and biomarker-positive subgroups.
Time Frame
Baseline
Title
Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Visual Analogic Scale
Description
EQ-5D Visual Analogic Scale:patients rated their overall health status from 0 (worst imaginable heath state) to 100 (best imaginable heath state).
Time Frame
Every 6 weeks up to 8 years
Title
Time to treatment discontinuation/failure due to toxicity (TTF)
Description
TTF is defined as the time from Cycle 1 Day 1 to the date of the first documentation of discontinuation due to an adverse event or death due to study treatment toxicity
Time Frame
From Cycle 1 Day 1, every 6 weeks up to the End of Treatment
Title
Treatment discontinuation/failure due to toxicity
Description
Treatment discontinuation is the percentage of patients who discontinue the treatment due to an adverse event or death due to study treatment toxicity
Time Frame
From Cycle 1 Day 1, every 6 weeks up to the End of Treatment
Title
PFS on next-line therapy (PFS2)
Description
PFS2 is defined as the time from randomization to discontinuation of next line treatment, second objective disease progression, or death from any cause, whichever occurs first.
Time Frame
From randomization up to 8 years.
Title
Progression Free Survival (PFS) in unselected patients
Description
Progression Free Survival (PFS) is the time from randomization to date of first documentation of objective progression of disease assessed by BICR (by RECIST version 1.1) or death due to any cause.
Time Frame
From randomization up to 40 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 providedas per documented regulations 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
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 dignosed 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Southern Cancer Center
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
Southern Cancer Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Facility Name
Southern Cancer Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Tower Hematology Oncology Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
LAC + USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC IDS Pharmacy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Cedars-Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Anschutz Cancer Center Pavilion Pharmacy
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Cancer Center Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Investigational Drug Service- Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
East Jefferson General Hospital
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
East Jefferson Hematology-Oncology Metairie Physician Service Inc.
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
New England Cancer Specialists
City
Kennebunk
State/Province
Maine
ZIP/Postal Code
04043
Country
United States
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
New England Cancer Specialists
City
Topsham
State/Province
Maine
ZIP/Postal Code
04086
Country
United States
Facility Name
Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
The Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
MedStar Health Cardiology Associates, LLC.
City
Brandywine
State/Province
Maryland
ZIP/Postal Code
20613
Country
United States
Facility Name
Cardiology Associates, P.C.
City
Chester
State/Province
Maryland
ZIP/Postal Code
21619
Country
United States
Facility Name
Massachusetts General Hospital (MGH)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Massachusetts General Hospital Clinical Trials Pharmacy
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center (BIDMC)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Beth Israel Deaconess Medical Center Pharmacy - BIDMC
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Baystate Franklin Medical Center
City
Greenfield
State/Province
Massachusetts
ZIP/Postal Code
01301
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Barnes-Jewish Hospital, Siteman Cancer Center - West County
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Barnes-Jewish Hospital, Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University Infusion Center Pharmacy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Barnes-Jewish Hospital, Siteman Cancer Center - South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
St. Vincent HealthCare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Frontier Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
75063
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Clifton Park
State/Province
New York
ZIP/Postal Code
12065
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy
City
Long Island City
State/Province
New York
ZIP/Postal Code
11101
Country
United States
Facility Name
Laura & Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Investigational Pharmacy
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
MSKCC-Monitoring Suite
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Sidney Kimmel Center for Prostate and Urologic Cancers
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-7007
Country
United States
Facility Name
Stony Brook University-Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-7263
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Novant Health Oncology Specialists
City
Kernersville
State/Province
North Carolina
ZIP/Postal Code
27284
Country
United States
Facility Name
Novant Health Oncology Specialists
City
Lexington
State/Province
North Carolina
ZIP/Postal Code
27295
Country
United States
Facility Name
Novant Health Oncology Specialists
City
Mount Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
Facility Name
Novant Health Oncology Specialists
City
North Wilkesboro
State/Province
North Carolina
ZIP/Postal Code
28659
Country
United States
Facility Name
Novant Health Clinical Research Onocolgy
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Novant Health Oncology Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Novant Health Winston Salem Health Care
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic Investigational Pharmacy
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
James Cancer Hospital and Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University - GU Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Cancer Care Associates Medical Oncology
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
St.Luke's Hospital-Allentown Campus
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Cancer Care Associate Medical Oncology
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
St.Luke's University Health Network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
St.Luke's Cancer Center Anderson
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
St.Luke's Hospital-Anderson Campus
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Investigational Drug Service, University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St.Luke's Quakertown Hospital
City
Quakertown
State/Province
Pennsylvania
ZIP/Postal Code
18951
Country
United States
Facility Name
Memorial Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
Henry-Joyce Cancer Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Vanderbilt University Oncology Pharmacy
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology- Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Product Center (IPC)
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Investigational Products Center (IPC)
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Investigational Products Center (lPC)
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
US Oncology Investigational Products Center (IPC)
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Rainier Hematology-Oncology, PC
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98373
Country
United States
Facility Name
Seattle Cancer Care Alliance / University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Northwest Medical Specialties, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Macquarie University Hospital Pharmacy
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Macquarie University
City
Macquarie University
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Nuclear Medicine Department
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Pharmacy Department, Clinical Trials
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Spectrum Medical Imaging
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Division of Cancer Services
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
BHS Diagnostic Services
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Lake Imaging
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Eastern Health
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Health Translational Precinct, Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Monash Cancer Centre
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Moorabbin Radiology
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Slade Health
City
Mount Waverley
State/Province
Victoria
ZIP/Postal Code
3149
Country
Australia
Facility Name
Ballarat Day Procedure Centre
City
Wendouree
State/Province
Victoria
ZIP/Postal Code
3355
Country
Australia
Facility Name
Ballarat Oncology & Haematology Services
City
Wendouree
State/Province
Victoria
ZIP/Postal Code
3355
Country
Australia
Facility Name
Nova Pharmacy
City
Wendouree
State/Province
Victoria
ZIP/Postal Code
3355
Country
Australia
Facility Name
SKG Radiology
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6050
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
SKG Radiology
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
St John of God Murdoch Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
EPIC Pharmacy Murdoch
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Krankenhaus der Barmherzigen Schwestern Wien
City
Wien
ZIP/Postal Code
1060
Country
Austria
Facility Name
Medizinische Universitaet Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency - Kelowna
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
BC Cancer GU Clinic - Fairmont Medical Building
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z IH7
Country
Canada
Facility Name
London Regional Cancer Program, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
London Regional Cancer Program, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Herlev Hospital, Onkologisk Afdeling R
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Centre Eugene Marquis Service Pharmacie - Essais Cliniques
City
Rennes
State/Province
Cedex
ZIP/Postal Code
35042
Country
France
Facility Name
Centre FRANCOIS BACLESSE
City
CAEN cedex 05
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Francois Baclesse
City
Caen, Cedex 05
ZIP/Postal Code
14076
Country
France
Facility Name
Centre de cancerologie de la Sarthe
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre de Cancérologie de la Sarthe (CCS) - Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Clinique Victor Hugo - Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Clinique Victor Hugo Centre de Cancerologie de la Sarthe
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Léon Bérard
City
Lyon cedex 8
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Léon Bérard
City
LYON cedex 8
ZIP/Postal Code
69373
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes cedex
ZIP/Postal Code
35042
Country
France
Facility Name
Institut de Cancérologie de l'Ouest - Centre René Gauducheau
City
Saint-Herblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Institut de Cancerologie de Lorraine (ICL)
City
Vandoeuvre les Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Institut de Cancerologie de Lorraine
City
Vandoeuvre les Nancy
ZIP/Postal Code
54519
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
State/Province
Baden-wuerttemberg
ZIP/Postal Code
072076
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
State/Province
Baden-wuerttemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Jena
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07743
Country
Germany
Facility Name
Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitaetsklinikum Jena
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07747
Country
Germany
Facility Name
Dél.pesti Centrumkórház-OHII Szent Lálszló Kórház telephely
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
State/Province
Ramat - GAN
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Assaf Harofe MC
City
Beer Yaakov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Shamir Medical Center
City
Beer Yaakov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Rambam Healthcare Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat - Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Centro di Riferimento Oncologico - IRCCS
City
Aviano
State/Province
(pn)
ZIP/Postal Code
33081
Country
Italy
Facility Name
Farmacia Studi Clinici
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
SC Farmacia
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Servizio di Farmacia
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Hirosaki University School of Medicine & Hospital
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaidô
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Shiwa-gun
State/Province
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Kindai University Hospital
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Hamamatsu University School of Medicine, University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Akita University Hospital
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Chiba Cancer Center
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Clinical Trial Pharmacy, National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-Si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital, Clinical Pharmacy
City
Seongnam-si
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Kyungpook National University Medical Center, Clinical Pharmacy
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Kyungpook National University Medical Center
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital, Clinical Pharmacy
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Seoul National University Hospital, Clinical Pharmacy
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Clinical Trial Pharmacy
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center Clinical Trial Pharmacy
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Instituto Nacional de Cancerologia
City
Mexico
State/Province
Ciudad DE Mexico
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Oaxaca Site Management Organization S.C.
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital
City
Amsterdam
State/Province
Noord-holland
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Netherlands Cancer Institute / Apotheek MC Slotervaart
City
Amsterdam
State/Province
Noord-holland
ZIP/Postal Code
1066 EC
Country
Netherlands
Facility Name
VU University Medical Center (VUmc)
City
Amsterdam
State/Province
Noord-holland
ZIP/Postal Code
1081 BT
Country
Netherlands
Facility Name
VU University Medical Center (VUmc)
City
Amsterdam
State/Province
Noord-holland
ZIP/Postal Code
1081 HZ
Country
Netherlands
Facility Name
Sint Franciscus Gasthuis, Pharmacy
City
Rotterdam
State/Province
Zuid-holland
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Sint Franciscus Gasthuis
City
Rotterdam
State/Province
Zuid-holland
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Eindhoven
ZIP/Postal Code
5631 BM
Country
Netherlands
Facility Name
St Apotheek der Haarlemse Ziekenhuizen
City
Haarlem
ZIP/Postal Code
2035 RC
Country
Netherlands
Facility Name
Spaarne Gasthuis
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Veldhoven
ZIP/Postal Code
5504 DL
Country
Netherlands
Facility Name
Auckland City Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Tauranga Hospital, Bay of Plenty Clinical Trials Unit
City
Tauranga
State/Province
BAY OF Plenty
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
Palmerston North Hospital
City
Palmerston North
State/Province
Manawatu-wanganui
ZIP/Postal Code
4414
Country
New Zealand
Facility Name
Tauranga Hospital
City
Tauranga Bay Of Plenty
State/Province
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Wairarapa District Health Board
City
Masterton
State/Province
Wairarapa
ZIP/Postal Code
5840
Country
New Zealand
Facility Name
Auckland City Hospital Pharmacy
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Baxter Healthcare New Zealand
City
Auckland
ZIP/Postal Code
1060
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8140
Country
New Zealand
Facility Name
Waikato Hospital Pharmacy Services
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Broadway Radiology
City
Palmerston North
ZIP/Postal Code
4410
Country
New Zealand
Facility Name
"Prof. Dr. Ion Chiricuta" Oncology Institute
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
S.C. Medisprof S.R.L.
City
Cluj-Napoca
ZIP/Postal Code
400641
Country
Romania
Facility Name
"Sfantul Nectarie" Oncology Center
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Oncomed SRL
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address)
City
Kursk
State/Province
Kursk Region
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR
City
Kursk
State/Province
Kursk Region
ZIP/Postal Code
305524
Country
Russian Federation
Facility Name
Russian Research Center for Radiology and Surgical Technologies
City
Saint Petersburg
State/Province
Pesochny
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF
City
Saint-Petersburg
State/Province
Poselok Pesochniy
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Private medical institution "Euromedservice"
City
Pushkin
State/Province
Saint-petersburg
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
Facility Name
Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
FBIH "Privolzhskiy Regional Medical Center" of FMBA
City
Nizhniy Novgorod
ZIP/Postal Code
603001
Country
Russian Federation
Facility Name
SBIH of Nizhegorodskaya region "Clinical-Diagnostics center"
City
Nizhniy Novgorod
ZIP/Postal Code
603006
Country
Russian Federation
Facility Name
FBIH "Privolzhskiy Regional Medical Center" of FMBA
City
Nizhniy Novgorod
ZIP/Postal Code
603032
Country
Russian Federation
Facility Name
FBIH "Privolzhskiy Regional Medical Center" of FMBA
City
Nizhniy Novgorod
ZIP/Postal Code
603109
Country
Russian Federation
Facility Name
SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary"
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Clinical Hospital #122 n.a. L. G. Sokolov
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
NS HI "Road Clinical Hospital of JSC "Russian Railways""
City
Saint Petersburg
ZIP/Postal Code
195271
Country
Russian Federation
Facility Name
LLC "Diagnostic center "Energo"
City
Saint Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
LLC "Clinical Diagnostic Center "Medex-pert"
City
Yaroslavl
ZIP/Postal Code
150014
Country
Russian Federation
Facility Name
SHI YR Regional Clinical Oncology Hospital
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
Clinica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Sahlgrenska University Hospital, Dept of Oncology
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre, East & North Herts NHS Trust
City
London
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre, Pharmacy
City
London
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey, London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Addenbrooke's Hospital, Central Pharmacy, Level 1
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Beatson WOSCC
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,
City
Glasgow
ZIP/Postal Code
G120YN
Country
United Kingdom
Facility Name
St Bartholomew's Hospital, Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Clinical Trials Pharmacy, The Christie
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Department of Medical Oncology, The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
35239416
Citation
Rini BI, Moslehi JJ, Bonaca M, Schmidinger M, Albiges L, Choueiri TK, Motzer RJ, Atkins MB, Haanen J, Mariani M, Wang J, Hariharan S, Larkin J. Prospective Cardiovascular Surveillance of Immune Checkpoint Inhibitor-Based Combination Therapy in Patients With Advanced Renal Cell Cancer: Data From the Phase III JAVELIN Renal 101 Trial. J Clin Oncol. 2022 Jun 10;40(17):1929-1938. doi: 10.1200/JCO.21.01806. Epub 2022 Mar 3.
Results Reference
derived
PubMed Identifier
35166465
Citation
Masters JC, Khandelwal A, di Pietro A, Dai H, Brar S. Model-informed drug development supporting the approval of the avelumab flat-dose regimen in patients with advanced renal cell carcinoma. CPT Pharmacometrics Syst Pharmacol. 2022 Apr;11(4):458-468. doi: 10.1002/psp4.12771. Epub 2022 Feb 27.
Results Reference
derived
PubMed Identifier
33947608
Citation
Rini BI, Atkins MB, Choueiri TK, Thomaidou D, Rosbrook B, Thakur M, Hutson TE. Time to Resolution of Axitinib-Related Adverse Events After Treatment Interruption in Patients With Advanced Renal Cell Carcinoma. Clin Genitourin Cancer. 2021 Oct;19(5):e306-e312. doi: 10.1016/j.clgc.2021.03.019. Epub 2021 Apr 5.
Results Reference
derived
PubMed Identifier
33901870
Citation
Choueiri TK, Larkin J, Pal S, Motzer RJ, Rini BI, Venugopal B, Alekseev B, Miyake H, Gravis G, Bilen MA, Hariharan S, Chudnovsky A, Ching KA, Mu XJ, Mariani M, Robbins PB, Huang B, di Pietro A, Albiges L. Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial. ESMO Open. 2021 Jun;6(3):100101. doi: 10.1016/j.esmoop.2021.100101. Epub 2021 Apr 23. Erratum In: ESMO Open. 2021 Aug;6(4):100177.
Results Reference
derived
PubMed Identifier
32895571
Citation
Motzer RJ, Robbins PB, Powles T, Albiges L, Haanen JB, Larkin J, Mu XJ, Ching KA, Uemura M, Pal SK, Alekseev B, Gravis G, Campbell MT, Penkov K, Lee JL, Hariharan S, Wang X, Zhang W, Wang J, Chudnovsky A, di Pietro A, Donahue AC, Choueiri TK. Avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma: biomarker analysis of the phase 3 JAVELIN Renal 101 trial. Nat Med. 2020 Nov;26(11):1733-1741. doi: 10.1038/s41591-020-1044-8. Epub 2020 Sep 7.
Results Reference
derived
PubMed Identifier
32339648
Citation
Choueiri TK, Motzer RJ, Rini BI, Haanen J, Campbell MT, Venugopal B, Kollmannsberger C, Gravis-Mescam G, Uemura M, Lee JL, Grimm MO, Gurney H, Schmidinger M, Larkin J, Atkins MB, Pal SK, Wang J, Mariani M, Krishnaswami S, Cislo P, Chudnovsky A, Fowst C, Huang B, di Pietro A, Albiges L. Updated efficacy results from the JAVELIN Renal 101 trial: first-line avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma. Ann Oncol. 2020 Aug;31(8):1030-1039. doi: 10.1016/j.annonc.2020.04.010. Epub 2020 Apr 25.
Results Reference
derived
PubMed Identifier
30779531
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.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B9991003
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
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