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

Renal Cell Cancer Clinical Trial

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

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
• 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
• 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)

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Cancer

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.

External Links

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