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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02684006
Other study ID # B9991003
Secondary ID 2015-002429-20JA
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 23, 2016
Est. completion date May 21, 2024

Study information

Verified date December 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 888
Est. completion date May 21, 2024
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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-a, 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Avelumab (MSB0010718C)
IV treatment Avelumab administered at 10 mg/kg IV every two weeks
Axitinib (AG-013736)
Oral treatment Axitinib given 5 mg PO BID
Sunitinib
Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2

Locations

Country Name City State
Australia BHS Diagnostic Services Ballarat Victoria
Australia Lake Imaging Ballarat Victoria
Australia Box Hill Hospital Box Hill Victoria
Australia Eastern Health Box Hill Victoria
Australia Monash Health Translational Precinct, Monash Medical Centre Clayton Victoria
Australia Monash Medical Centre Clayton Victoria
Australia Monash Cancer Centre East Bentleigh Victoria
Australia Moorabbin Radiology East Bentleigh Victoria
Australia Macquarie University Macquarie University New South Wales
Australia Macquarie University Hospital Pharmacy Macquarie University New South Wales
Australia Slade Health Mount Waverley Victoria
Australia Fiona Stanley Hospital Murdoch Western Australia
Australia SKG Radiology Murdoch Western Australia
Australia SKG Radiology Murdoch Western Australia
Australia St John of God Murdoch Hospital Murdoch Western Australia
Australia EPIC Pharmacy Murdoch Perth Western Australia
Australia Nuclear Medicine Department Randwick New South Wales
Australia Pharmacy Department, Clinical Trials Randwick New South Wales
Australia Prince of Wales Hospital Randwick New South Wales
Australia Spectrum Medical Imaging Randwick New South Wales
Australia Ballarat Day Procedure Centre Wendouree Victoria
Australia Ballarat Oncology & Haematology Services Wendouree Victoria
Australia Nova Pharmacy Wendouree Victoria
Australia Division of Cancer Services Woolloongabba Queensland
Austria Krankenhaus der Barmherzigen Schwestern Wien Wien
Austria Medizinische Universitaet Wien Wien
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium Cliniques Universitaires Saint-Luc Bruxelles
Belgium UZ Gent Gent
Belgium AZ Groeninge Kortrijk
Belgium CHU de Liège Liège
Canada Alberta Health Services - Cancer Care, Tom Baker Cancer Centre Calgary Alberta
Canada Foothills Medical Centre Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada British Columbia Cancer Agency - Kelowna Kelowna British Columbia
Canada British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior Kelowna British Columbia
Canada London Regional Cancer Program, London Health Sciences Centre London Ontario
Canada London Regional Cancer Program, London Health Sciences Centre London Ontario
Canada Jewish General Hospital Montreal Quebec
Canada R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health Oshawa Ontario
Canada CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke Sherbrooke Quebec
Canada Sunnybrook Research Institute Toronto Ontario
Canada BC Cancer GU Clinic - Fairmont Medical Building Vancouver British Columbia
Canada British Columbia Cancer Agency Vancouver British Columbia
Denmark Herlev Hospital, Onkologisk Afdeling R Herlev
Denmark Odense Universitetshospital Odense C
France Centre FRANCOIS BACLESSE CAEN cedex 05
France Centre Francois Baclesse Caen, Cedex 05
France Centre de cancerologie de la Sarthe Le Mans
France Centre de Cancérologie de la Sarthe (CCS) - Clinique Victor Hugo Le Mans
France Clinique Victor Hugo Le Mans
France Clinique Victor Hugo - Centre Jean Bernard Le Mans
France Clinique Victor Hugo Centre de Cancerologie de la Sarthe Le Mans
France Centre Léon Bérard Lyon cedex 8
France Centre Léon Bérard LYON cedex 8
France Institut Paoli Calmettes Marseille
France Centre Eugene Marquis Service Pharmacie - Essais Cliniques Rennes Cedex
France Centre Eugene Marquis Rennes cedex
France Institut de Cancérologie de l'Ouest - Centre René Gauducheau Saint-Herblain Cedex
France Institut de Cancerologie de Lorraine Vandoeuvre les Nancy
France Institut de Cancerologie de Lorraine (ICL) Vandoeuvre les Nancy
France Institut Gustave Roussy Villejuif
Germany Universitaetsklinikum Jena Jena Thuringia
Germany Universitaetsklinikum Jena Jena Thuringia
Germany Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie Jena Thuringia
Germany Universitaetsklinikum Tuebingen Tuebingen Baden-wuerttemberg
Germany Universitaetsklinikum Tuebingen Tuebingen Baden-wuerttemberg
Hungary Dél.pesti Centrumkórház-OHII Szent Lálszló Kórház telephely Budapest
Hungary Országos Onkológiai Intézet Budapest
Israel Assaf Harofe MC Beer Yaakov
Israel Shamir Medical Center Beer Yaakov
Israel Rambam Health Care Campus Haifa
Israel Rambam Healthcare Campus Haifa
Israel Meir Medical Center Kfar Saba
Israel Rabin Medical Center Petach Tikva
Israel The Chaim Sheba Medical Center Ramat - Gan
Israel Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center Tel Aviv
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Israel The Chaim Sheba Medical Center Tel-Hashomer Ramat - GAN
Italy Centro di Riferimento Oncologico - IRCCS Aviano (pn)
Italy Fondazione IRCCS Istituto Nazionale dei Tumori Milan
Italy Istituto Europeo di Oncologia Milan
Italy SC Farmacia Milan
Italy Servizio di Farmacia Milan
Italy Azienda Ospedaliera San Camillo Forlanini Rome
Italy Farmacia Studi Clinici Rozzano Milan
Italy Istituto Clinico Humanitas Rozzano Milan
Japan Akita University Hospital Akita
Japan Chiba Cancer Center Chiba
Japan Kyushu University Hospital Fukuoka
Japan Hamamatsu University School of Medicine, University Hospital Hamamatsu Shizuoka
Japan Hirosaki University School of Medicine & Hospital Hirosaki Aomori
Japan Nagoya University Hospital Nagoya Aichi
Japan Niigata University Medical & Dental Hospital Niigata
Japan Kindai University Hospital Osakasayama Osaka
Japan Hokkaido University Hospital Sapporo Hokkaidô
Japan Keio University Hospital Shinjuku-ku Tokyo
Japan Tokyo Women's Medical University Hospital Shinjuku-ku Tokyo
Japan Iwate Medical University Hospital Shiwa-gun Iwate
Japan Osaka University Hospital Suita Osaka
Japan Tokushima University Hospital Tokushima
Japan Yamagata University Hospital Yamagata
Japan Yokohama City University Hospital Yokohama Kanagawa
Korea, Republic of Kyungpook National University Medical Center Daegu
Korea, Republic of Kyungpook National University Medical Center, Clinical Pharmacy Daegu
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of Chungnam National University Hospital, Clinical Pharmacy Daejeon
Korea, Republic of Clinical Trial Pharmacy, National Cancer Center Goyang-si Gyeonggi-do
Korea, Republic of National Cancer Center Goyang-Si Gyeonggi-do
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggido
Korea, Republic of Seoul National University Bundang Hospital, Clinical Pharmacy Seongnam-si Gyeonggido
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Clinical Trial Pharmacy Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Samsung Medical Center Clinical Trial Pharmacy Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul National University Hospital, Clinical Pharmacy Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Mexico Instituto Nacional de Cancerologia Mexico Ciudad DE Mexico
Mexico Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer Monterrey Nuevo LEON
Mexico Oaxaca Site Management Organization S.C. Oaxaca
Netherlands Netherlands Cancer Institute / Apotheek MC Slotervaart Amsterdam Noord-holland
Netherlands Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital Amsterdam Noord-holland
Netherlands VU University Medical Center (VUmc) Amsterdam Noord-holland
Netherlands VU University Medical Center (VUmc) Amsterdam Noord-holland
Netherlands Maxima Medisch Centrum Eindhoven
Netherlands St Apotheek der Haarlemse Ziekenhuizen Haarlem
Netherlands Spaarne Gasthuis Hoofddorp
Netherlands Maastricht University Medical Center Maastricht
Netherlands Sint Franciscus Gasthuis Rotterdam Zuid-holland
Netherlands Sint Franciscus Gasthuis, Pharmacy Rotterdam Zuid-holland
Netherlands Maxima Medisch Centrum Veldhoven
Netherlands Maxima Medisch Centrum Veldhoven
New Zealand Auckland City Hospital Pharmacy Auckland
New Zealand Baxter Healthcare New Zealand Auckland
New Zealand Christchurch Hospital Christchurch
New Zealand Auckland City Hospital Grafton Auckland
New Zealand Waikato Hospital Hamilton
New Zealand Waikato Hospital Pharmacy Services Hamilton
New Zealand Wairarapa District Health Board Masterton Wairarapa
New Zealand Broadway Radiology Palmerston North
New Zealand Palmerston North Hospital Palmerston North Manawatu- Whanganui
New Zealand Palmerston North Hospital Palmerston North Manawatu-wanganui
New Zealand Tauranga Hospital, Bay of Plenty Clinical Trials Unit Tauranga BAY OF Plenty
New Zealand Tauranga Hospital Tauranga Bay Of Plenty Tauranga
Romania "Prof. Dr. Ion Chiricuta" Oncology Institute Cluj-Napoca
Romania S.C. Medisprof S.R.L. Cluj-Napoca
Romania "Sfantul Nectarie" Oncology Center Craiova
Romania Oncomed SRL Timisoara
Russian Federation RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR Kursk Kursk Region
Russian Federation RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address) Kursk Kursk Region
Russian Federation Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen Moscow
Russian Federation Scientific Research Institute of Urology named after N.A.Lopatkin of the Hersten Federal Moscow
Russian Federation FBIH "Privolzhskiy Regional Medical Center" of FMBA Nizhniy Novgorod
Russian Federation FBIH "Privolzhskiy Regional Medical Center" of FMBA Nizhniy Novgorod
Russian Federation FBIH "Privolzhskiy Regional Medical Center" of FMBA Nizhniy Novgorod
Russian Federation SBIH of Nizhegorodskaya region "Clinical-Diagnostics center" Nizhniy Novgorod
Russian Federation SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary" Nizhniy Novgorod
Russian Federation Private medical institution "Euromedservice" Pushkin Saint-petersburg
Russian Federation Clinical Hospital #122 n.a. L. G. Sokolov Saint Petersburg
Russian Federation LLC "Diagnostic center "Energo" Saint Petersburg
Russian Federation NS HI "Road Clinical Hospital of JSC "Russian Railways"" Saint Petersburg
Russian Federation Russian Research Center for Radiology and Surgical Technologies Saint Petersburg Pesochny
Russian Federation FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF Saint-Petersburg Poselok Pesochniy
Russian Federation LLC "Clinical Diagnostic Center "Medex-pert" Yaroslavl
Russian Federation SHI YR Regional Clinical Oncology Hospital Yaroslavl
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Clinica Universidad de Navarra Pamplona Navarra
Spain Hospital Universitario Virgen del Rocio Sevilla
Sweden Sahlgrenska University Hospital, Dept of Oncology Gothenburg
United Kingdom Addenbrooke's Hospital, Central Pharmacy, Level 1 Cambridge
United Kingdom Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital Cambridge Cambridgeshire
United Kingdom Beatson West of Scotland Cancer Centre, Gartnavel General Hospital, Glasgow
United Kingdom Beatson WOSCC Glasgow
United Kingdom Mount Vernon Cancer Centre, East & North Herts NHS Trust London Middlesex
United Kingdom Mount Vernon Cancer Centre, Pharmacy London Middlesex
United Kingdom St Bartholomew's Hospital, Barts Health NHS Trust London
United Kingdom The Royal Marsden NHS Foundation Trust London
United Kingdom Clinical Trials Pharmacy, The Christie Manchester
United Kingdom Department of Medical Oncology, The Christie NHS Foundation Trust Manchester
United Kingdom Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus Nottingham
United Kingdom Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy Nottingham
United Kingdom The Royal Marsden NHS Foundation Trust Sutton Surrey, London
United Kingdom The Royal Marsden NHS Foundation Trust Sutton Surrey
United States New York Oncology Hematology, P.C. Albany New York
United States New York Oncology Hematology, PC Albany New York
United States Cancer Care Associates Medical Oncology Allentown Pennsylvania
United States St.Luke's Hospital-Allentown Campus Allentown Pennsylvania
United States Emory University Hospital Atlanta Georgia
United States Investigational Drug Service- Emory University Atlanta Georgia
United States The Emory Clinic Atlanta Georgia
United States Winship Cancer Institute, Emory University Atlanta Georgia
United States Anschutz Cancer Center Pavilion Pharmacy Aurora Colorado
United States Rocky Mountain Cancer Centers Aurora Colorado
United States University of Colorado Cancer Center Anschutz Cancer Pavilion Aurora Colorado
United States University of Colorado Hospital Aurora Colorado
United States University of Colorado Hospital - Clinical Trials Office (CTO) Aurora Colorado
United States John Hopkins Hospital Baltimore Maryland
United States Johns Hopkins Hospital Baltimore Maryland
United States Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Baltimore Maryland
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland
United States The Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland
United States Cancer Care Associate Medical Oncology Bethlehem Pennsylvania
United States St. Lukes University Health Network Bethlehem Pennsylvania
United States St.Luke's University Health Network Bethlehem Pennsylvania
United States Tower Hematology Oncology Medical Group Beverly Hills California
United States St. Vincent Frontier Cancer Center Billings Montana
United States St. Vincent HealthCare Billings Montana
United States Beth Israel Deaconess Medical Center (BIDMC) Boston Massachusetts
United States Beth Israel Deaconess Medical Center Pharmacy - BIDMC Boston Massachusetts
United States Brigham & Women's Hospital Boston Massachusetts
United States Dana - Farber Cancer Institute Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital (MGH) Boston Massachusetts
United States Massachusetts General Hospital Clinical Trials Pharmacy Boston Massachusetts
United States MedStar Health Cardiology Associates, LLC. Brandywine Maryland
United States Cardiology Associates, P.C. Chester Maryland
United States Cleveland Clinic Cleveland Ohio
United States Cleveland Clinic Investigational Pharmacy Cleveland Ohio
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States New York Oncology Hematology, P.C. Clifton Park New York
United States Rocky Mountain Cancer Centers Colorado Springs Colorado
United States James Cancer Hospital and Solove Research Institute Columbus Ohio
United States The Ohio State University Columbus Ohio
United States The Ohio State University - GU Clinic Columbus Ohio
United States Barnes-Jewish Hospital, Siteman Cancer Center - West County Creve Coeur Missouri
United States Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas
United States Southern Cancer Center Daphne Alabama
United States City of Hope Duarte California
United States City of Hope National Medical Center Duarte California
United States St.Luke's Cancer Center Anderson Easton Pennsylvania
United States St.Luke's Hospital-Anderson Campus Easton Pennsylvania
United States Baystate Franklin Medical Center Greenfield Massachusetts
United States Texas Oncology - Gulf Coast Houston Texas
United States Texas Oncology- Memorial City Houston Texas
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Investigational Product Center (IPC) Irving Texas
United States Investigational Products Center (IPC) Irving Texas
United States Investigational Products Center (lPC) Irving Texas
United States US Oncology Investigational Products Center (IPC) Irving Texas
United States New England Cancer Specialists Kennebunk Maine
United States Novant Health Oncology Specialists Kernersville North Carolina
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Novant Health Oncology Specialists Lexington North Carolina
United States Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy Long Island City New York
United States Cedars-Sinai Los Angeles California
United States Cedars-Sinai Advanced Health Sciences Pavilion Los Angeles California
United States Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute Los Angeles California
United States Keck Hospital of USC Los Angeles California
United States LAC + USC Medical Center Los Angeles California
United States USC IDS Pharmacy Los Angeles California
United States USC/Norris Comprehensive Cancer Center Los Angeles California
United States Joe Arrington Cancer Research and Treatment Center Lubbock Texas
United States East Jefferson General Hospital Metairie Louisiana
United States East Jefferson Hematology-Oncology Metairie Physician Service Inc. Metairie Louisiana
United States Southern Cancer Center Mobile Alabama
United States Southern Cancer Center Mobile Alabama
United States Novant Health Oncology Specialists Mount Airy North Carolina
United States Henry-Joyce Cancer Clinic Nashville Tennessee
United States Oncology IDS Pharmacy Nashville Tennessee
United States Vanderbilt University Oncology Pharmacy Nashville Tennessee
United States Vanderbilt-Ingram Cancer Center Nashville Tennessee
United States Evelyn H. Lauder Breast and Imaging Center New York New York
United States Laura & Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States MSKCC-Monitoring Suite New York New York
United States NYU Investigational Pharmacy New York New York
United States NYU Langone Medical Center New York New York
United States Sidney Kimmel Center for Prostate and Urologic Cancers New York New York
United States Novant Health Oncology Specialists North Wilkesboro North Carolina
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Investigational Drug Service, University of Pennsylvania Philadelphia Pennsylvania
United States Rainier Hematology-Oncology, PC Puyallup Washington
United States St.Luke's Quakertown Hospital Quakertown Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States Barnes-Jewish Hospital, Siteman Cancer Center Saint Louis Missouri
United States Barnes-Jewish Hospital, Siteman Cancer Center - South County Saint Louis Missouri
United States Washington University Infusion Center Pharmacy Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters Saint Peters Missouri
United States New England Cancer Specialists Scarborough Maine
United States Fred Hutchinson Cancer Center Seattle Washington
United States Seattle Cancer Care Alliance Seattle Washington
United States Seattle Cancer Care Alliance / University of Washington Seattle Washington
United States University of Washington Medical Center Seattle Washington
United States Stony Brook University Stony Brook New York
United States Stony Brook University Stony Brook New York
United States Stony Brook University-Cancer Center Stony Brook New York
United States Northwest Medical Specialties, PLLC Tacoma Washington
United States Moffitt Cancer Center and Research Institute Tampa Florida
United States New England Cancer Specialists Topsham Maine
United States Georgetown University Medical Center Washington District of Columbia
United States Novant Health Clinical Research Onocolgy Winston-Salem North Carolina
United States Novant Health Oncology Specialists Winston-Salem North Carolina
United States Novant Health Winston Salem Health Care Winston-Salem North Carolina
United States Memorial Hospital York Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Romania,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. From randomization up to 40 months.
Primary Overall Survival in PD-L1 positive patients OS is the time from date of randomization to date of death due to any cause. Every 3 months up to 8 years
Secondary Overall Survival (OS) in unselected patients OS is the time from date of randomization to date of death due to any cause. Every 3 months up to 8 years
Secondary 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) Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Secondary 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. Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Secondary Time to Tumor Response (TTR) TRR is the time from randomization to first documentation of objective tumor response (CR or PR). Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Secondary 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 Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Secondary 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. Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 40 months from randomization
Secondary Trough plasma concentration (Ctrough) of avelumab Ctrough is defined as the concentration at the end of avelumab dosage interval Pre-dose
Secondary Trough plasma concentration (Ctrough) of axitinib Ctrough is defined as the concentration at the end of axitinib dosage interval Pre-dose
Secondary Maximum plasma concentration (Cmax) of axitinib Cmax defined as the maximum plasma concentration of axitinib 2 hours post-dose
Secondary Anti-Drug Antibody (ADA) levels of avelumab/Neutralizing antibodies titers for MSB0010718C Immunogenicity assessment of avelumab Pre-dose
Secondary 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 Baseline
Secondary Overall Survival (OS) in biomarker-positive and biomarker-negative subgroups OS in biomarker-negative and biomarker-positive subgroups. Baseline
Secondary 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. Every 6 weeks up to 8 years
Secondary 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. Every 6 weeks up to 8 years
Secondary Progression Free Survival (PFS) in biomarker-positive and biomarker-negative subgroups PFS as measure of clinical outcome in biomarker-negative and biomarker-positive subgroups. Baseline
Secondary Objective Response (OR) in biomarker-positive and biomarker-negative subgroups OR in biomarker-negative and biomarker-positive subgroups Baseline
Secondary Disease Control (DC) in biomarker-positive and biomarker-negative subgroups DC in biomarker-negative and biomarker-positive subgroups Baseline
Secondary Time To Response (TTR) in biomarker-positive and biomarker-negative subgroups TTR in biomarker-negative and biomarker-positive subgroups. Baseline
Secondary Duration of Response (DR) in biomarker-positive and biomarker-negative subgroups DR in biomarker-negative and biomarker-positive subgroups. Baseline
Secondary 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). Every 6 weeks up to 8 years
Secondary 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 From Cycle 1 Day 1, every 6 weeks up to the End of Treatment
Secondary 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 From Cycle 1 Day 1, every 6 weeks up to the End of Treatment
Secondary 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. From randomization up to 8 years.
Secondary 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. From randomization up to 40 months.
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