Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor)
NCT ID: NCT01772004
Last Updated: 2021-12-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
1756 participants
INTERVENTIONAL
2013-01-31
2019-12-16
Brief Summary
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Active cohorts: Escalation revised dosing regimen cohort.
Closed cohorts: Non-small cell lung cancer (NSCLC, first line), NSCLC (post-platinum), metastatic breast cancer (MBC), colorectal cancer (CRC), urothelial carcinoma (secondary), mesothelioma, gastric/GEJ cancer (first line switch maintenance and second line), and ovarian cancer (secondary and platinum refractory + liposomal doxorubicin), renal cell carcinoma (second line) melanoma and head, neck squamous cell carcinoma (HNSCC), castrate-resistant prostate cancer (CRPC), adrenocortical carcinoma (ACC) urothelial carcinoma (efficacy), gastric/gastroesophageal junction (GEJ) cancer (third line), renal cell carcinoma (RCC, first line) and escalation phase .
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Cohort: Avelumab 1.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Dose Escalation Cohort: Avelumab 3.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Dose Escalation Cohort: Avelumab 10.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Dose Escalation Cohort: Avelumab 20.0 mg/kg
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: NSCLC, Post-platinum Doublet
Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: NSCLC, First Line
Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: Metastatic Breast Cancer
Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: GC/GEJC Progressed
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who progressed on or after first line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Primary Expansion Cohort: GC/GEJC Non Progressed
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Colorectal Cancer
Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Adrenocortical Carcinoma
Participants with adrenocortical carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Melanoma
Participants with melanoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Mesothelioma
Participants with mesothelioma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)
Participants with Renal cell carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a first-line therapy in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)
Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Efficacy Expansion Cohort: Ovarian Cancer
Participants with ovarian carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Efficacy Expansion Cohort: Urothelial Carcinoma
Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Efficacy Expansion Cohort: GC/ GEJC, Third Line
Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Efficacy Expansion Cohort: HNSCC
Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Interventions
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Avelumab
Participants received intravenous infusion of Avelumab in dose escalation and expansion cohorts until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female participants aged greater than or equal to 18 years
* Participants must have histologically or cytologically proven metastatic or locally advanced solid tumors, for which no standard therapy exists or standard therapy has failed. Availability of tumor archival material or fresh biopsies is optional for participants in dose escalation
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months
* Disease must be measurable with at least 1 uni-dimensional measurable lesion by RECIST 1.1, except for participants with metastatic castrate-resistant prostate cancer (mCRPC) or metastatic breast cancer (MBC) who may be enrolled with objective evidence of disease without a measureable lesion
* Adequate hematological, hepatic and renal function as defined in the protocol
* Effective contraception for both male and female participants if the risk of conception exists
* Participants must have relapsed, refractory, or progressive disease following last line of treatment (with the exception of the gastric and gastroesophageal junction (GEJ) cancer cohort, which does not require progression). Availability of tumor archival material or fresh biopsies (excluding bone biopsies) is mandatory for eligibility in the expansion cohorts. For participants in the MBC cohort, the biopsy or surgical specimen must have been collected within 90 days prior to the first investigational medicinal product (IMP) administration. Specifically, the following will be required:
* NSCLC post platinum doublet: Histologically or cytologically confirmed stage IIIB or stage IV NSCLC that has progressed after 1 line of platinum-containing doublet chemotherapy. Participants should have received only 1 line of platinum-containing treatment for metastatic disease (i.e., adjuvant treatment with a platinum-containing regimen is not sufficient for eligibility because not received in the context of a metastatic disease). Participants in the NSCLC cohort will only be enrolled in USA
* NSCLC first line: Stage IV (per 7th International Association for the Study of Lung Cancer \[IASLC\] classification) or recurrent NSCLC that is histologically proven. Participants must not have received treatment for their metastatic or recurrent disease. No activating epidermal growth factor receptor (EGFR) mutation nor ALK translocation/re-arrangement
* Gastric and GEJ cancer: Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction, treated with first-line chemotherapy combination with or without disease progression. Participants should have received no more than 1 line of treatment for metastatic disease. Participants should not have been treated with trastuzumab (but can be Human Epidermal growth factor Receptor 2 \[HER2\] positive). Participants who received any platinum containing doublet or triplet as a neoadjuvant chemotherapy strategy, but are not ultimately candidates for surgery will also be eligible, as long as they did not have progressive disease after completion of the neoadjuvant chemotherapy. In addition, participants with gastric cancer can enter in the study if their white blood cell (WBC) and lymphocyte count is as defined in the protocol
* MBC: Participants must have histologically confirmed locally advanced or MBC and have tumor that is refractory to or progressive after standard of care therapy. Participants must have received no more than 3 prior lines of cytotoxic therapy for metastatic disease. Participants must have received a taxane and an anthracycline, unless contra-indicated
* Secondary expansion cohorts: Metastatic colorectal cancer (mCRC), Metastatic castrate-resistant prostate cancer (mCRPC), melanoma, ovarian cancer, ACC, mesothelioma, urothelial carcinoma and renal cell carcinoma as defined in the protocol
* Efficacy expansion cohorts: Gastric and GEJ cancer (third line), ovarian cancer (platinum Refractory + liposomal doxorubicin), urothelial carcinoma, and HNSCC as defined in the protocol
Exclusion Criteria
* Prior therapy with specific antibody/drug targeting T cell co-regulatory proteins (immune checkpoints)
* Concurrent anticancer treatment, major surgery, or use of any investigational drug within 28 days before the start of trial treatment; or concurrent systemic therapy with immunosuppressive agents, use of hormonal agents within 7 days before the start of trial treatment as defined in the protocol. Note: Participants receiving bisphosphonate or denosumab are eligible provided treatment was initiated at least 14 days before the first dose of avelumab.
* Previous malignant disease other than the target malignancy to be investigated in this trial within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ
* Rapidly progressive disease (for example, tumor lysis syndrome)
* Active or history of central nervous system metastases
* Receipt of any organ transplantation including allogeneic stem-cell transplantation
* Significant acute or chronic infections as defined in the protocol
* Active or history of any autoimmune disease (Participants with diabetes Type 1, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies
* Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma
* Persisting toxicity related to prior therapy greater than Grade 1 NCI-CTCAE v4.0, however sensory neuropathy less than or equal to Grade 2 is acceptable
* Pregnancy or lactation period
* Known alcohol or drug abuse
* Clinically significant (that is, active) cardiovascular disease
* All other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the investigator, might impair the Participant's tolerance of trial treatment
* Any psychiatric condition that would prohibit the understanding or rendering of informed consent
* Legal incapacity or limited legal capacity
* Non-oncology vaccine therapies for prevention of infection disease (for example, seasonal flu vaccine, human papilloma virus vaccine) within 4 weeks of study drug administration. Vaccination while on study is also prohibited except for administration of the inactivated influenza vaccine
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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Cancer Treatment Centers of America - Western Regional Medical Center
Goodyear, Arizona, United States
Scottsdale Healthcare Corporation
Scottsdale, Arizona, United States
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States
Highlands Oncology Group
Rogers, Arkansas, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States
California Cancer Associates for Research & Excellence, Inc
Encinitas, California, United States
Healing Hands Oncology and Medical Care
Inglewood, California, United States
Scripps Health dba Scripps Clinical Research Services
La Jolla, California, United States
The Angeles Clinic and Research Institute - West LA
Los Angeles, California, United States
Cedars-Sinai Medical Center - Oncology
Los Angeles, California, United States
University of California Davis Health System
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Georgetown University Medical Center- Research Parent
Washington D.C., District of Columbia, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
University of Miami
Miami, Florida, United States
Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States
Peachtree Hematology-Oncology Consultants, PC
Atlanta, Georgia, United States
Augusta University - formerly Georgia Regents University
Augusta, Georgia, United States
Northwest Georgia Oncology Centers PC
Marietta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Horizon Oncology Research, INC
Lafayette, Indiana, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
RCCA MD LLC - Bethesda
Bethesda, Maryland, United States
National Cancer Institute
Bethesda, Maryland, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Medical Center
Detroit, Michigan, United States
Michigan State University
Lansing, Michigan, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Kansas City Research Institute, LLC - Phase I Unit
Kansas City, Missouri, United States
Washington University in St. Louis
St Louis, Missouri, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Columbia University College of Phys & Surgeons
New York, New York, United States
Montefiore Medical Center PRIME
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center
Huntersville, North Carolina, United States
UC Health Clinical Trials Office
Cincinnati, Ohio, United States
University Hospitals Case Medical Center - Case Comprehensive Cancer Center
Cleveland, Ohio, United States
OSU - James Comprehensive Cancer Center - Division of Hematology
Columbus, Ohio, United States
Mid Ohio Oncology Hematology, DBA The Mark H. Zangmeister Center - d/b/a The Mark H. Zangmeister Center
Columbus, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Penn State Univ. Milton S. Hershey Medical Center - MSHMC Cardiology
Hershey, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The West Clinic
Germantown, Tennessee, United States
Baptist Cancer Center
Memphis, Tennessee, United States
SCRI - Tennessee Oncology
Nashville, Tennessee, United States
Texas Oncology, P.A
Dallas, Texas, United States
Oncology Consultants, P.A.
Houston, Texas, United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, United States
Northwest Medical Specialties, PLLC
Lakewood, Washington, United States
GZA Ziekenhuizen - Campus Sint-Augustinus
Wilrijk, , Belgium
Nemocnice Rudolfa a Stefanie Benesov, a.s.
Benešov, , Czechia
ICO - Site Paul Papin - service d'oncologie medicale
Angers, , France
Centre Léon Bérard
Lyon, , France
Centre Antoine Lacassagne
Nice, , France
Centre Paul Strauss - Service de Médecine Oncologique
Strasbourg, , France
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato.
Mainz, , Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH - Innere Medizin II Haematologie / Onkologie
Villingen-Schwenningen, , Germany
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie - Dept of Digestive System Oncology
Warsaw, , Poland
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Sarah Cannon Research Institute UK
London, , United Kingdom
Derriford Hospital - Dept of Oncology Clinical Trials
Plymouth, , United Kingdom
Countries
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References
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Apolo AB, Infante JR, Balmanoukian A, Patel MR, Wang D, Kelly K, Mega AE, Britten CD, Ravaud A, Mita AC, Safran H, Stinchcombe TE, Srdanov M, Gelb AB, Schlichting M, Chin K, Gulley JL. Avelumab, an Anti-Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study. J Clin Oncol. 2017 Jul 1;35(19):2117-2124. doi: 10.1200/JCO.2016.71.6795. Epub 2017 Apr 4.
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Madan RA, Redman JM, Karzai F, Dahut WL, Cordes L, Fakhrejahani F, Vu T, Sheikh N, Schlom J, Gulley JL. Avelumab in Men With Metastatic Castration-Resistant Prostate Cancer, Enriched for Patients Treated Previously With a Therapeutic Cancer Vaccine. J Immunother. 2023 May 1;46(4):145-151. doi: 10.1097/CJI.0000000000000459. Epub 2023 Feb 24.
Guigay J, Lee KW, Patel MR, Daste A, Wong DJ, Goel S, Gordon MS, Gutierrez M, Balmanoukian A, Le Tourneau C, Mita A, Vansteene D, Keilholz U, Schoffski P, Grote HJ, Zhou D, Bajars M, Penel N. Avelumab for platinum-ineligible/refractory recurrent and/or metastatic squamous cell carcinoma of the head and neck: phase Ib results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2021 Oct;9(10):e002998. doi: 10.1136/jitc-2021-002998.
Kelly K, Manitz J, Patel MR, D'Angelo SP, Apolo AB, Rajan A, Kasturi V, Speit I, Bajars M, Warth J, Gulley JL. Efficacy and immune-related adverse event associations in avelumab-treated patients. J Immunother Cancer. 2020 Nov;8(2):e001427. doi: 10.1136/jitc-2020-001427.
Verschraegen CF, Jerusalem G, McClay EF, Iannotti N, Redfern CH, Bennouna J, Chen FL, Kelly K, Mehnert J, Morris JC, Taylor M, Spigel D, Wang D, Grote HJ, Zhou D, Munshi N, Bajars M, Gulley JL. Efficacy and safety of first-line avelumab in patients with advanced non-small cell lung cancer: results from a phase Ib cohort of the JAVELIN Solid Tumor study. J Immunother Cancer. 2020 Sep;8(2):e001064. doi: 10.1136/jitc-2020-001064.
Del Rivero J, Donahue RN, Marte JL, Gramza AW, Bilusic M, Rauckhorst M, Cordes L, Merino MJ, Dahut WL, Schlom J, Gulley JL, Madan RA. A Case Report of Sequential Use of a Yeast-CEA Therapeutic Cancer Vaccine and Anti-PD-L1 Inhibitor in Metastatic Medullary Thyroid Cancer. Front Endocrinol (Lausanne). 2020 Aug 7;11:490. doi: 10.3389/fendo.2020.00490. eCollection 2020.
Vaishampayan U, Schoffski P, Ravaud A, Borel C, Peguero J, Chaves J, Morris JC, Kotecki N, Smakal M, Zhou D, Guenther S, Bajars M, Gulley JL. Avelumab monotherapy as first-line or second-line treatment in patients with metastatic renal cell carcinoma: phase Ib results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2019 Oct 24;7(1):275. doi: 10.1186/s40425-019-0746-2.
Rajan A, Heery CR, Thomas A, Mammen AL, Perry S, O'Sullivan Coyne G, Guha U, Berman A, Szabo E, Madan RA, Ballester LY, Pittaluga S, Donahue RN, Tsai YT, Lepone LM, Chin K, Ginty F, Sood A, Hewitt SM, Schlom J, Hassan R, Gulley JL. Efficacy and tolerability of anti-programmed death-ligand 1 (PD-L1) antibody (Avelumab) treatment in advanced thymoma. J Immunother Cancer. 2019 Oct 21;7(1):269. doi: 10.1186/s40425-019-0723-9.
Novakovic AM, Wilkins JJ, Dai H, Wade JR, Neuteboom B, Brar S, Bello CL, Girard P, Khandelwal A. Changing Body Weight-Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma. Clin Pharmacol Ther. 2020 Mar;107(3):588-596. doi: 10.1002/cpt.1645. Epub 2019 Nov 18.
Chung HC, Arkenau HT, Lee J, Rha SY, Oh DY, Wyrwicz L, Kang YK, Lee KW, Infante JR, Lee SS, Kemeny M, Keilholz U, Melichar B, Mita A, Plummer R, Smith D, Gelb AB, Xiong H, Hong J, Chand V, Safran H. Avelumab (anti-PD-L1) as first-line switch-maintenance or second-line therapy in patients with advanced gastric or gastroesophageal junction cancer: phase 1b results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2019 Feb 4;7(1):30. doi: 10.1186/s40425-019-0508-1.
Disis ML, Taylor MH, Kelly K, Beck JT, Gordon M, Moore KM, Patel MR, Chaves J, Park H, Mita AC, Hamilton EP, Annunziata CM, Grote HJ, von Heydebreck A, Grewal J, Chand V, Gulley JL. Efficacy and Safety of Avelumab for Patients With Recurrent or Refractory Ovarian Cancer: Phase 1b Results From the JAVELIN Solid Tumor Trial. JAMA Oncol. 2019 Mar 1;5(3):393-401. doi: 10.1001/jamaoncol.2018.6258.
Keilholz U, Mehnert JM, Bauer S, Bourgeois H, Patel MR, Gravenor D, Nemunaitis JJ, Taylor MH, Wyrwicz L, Lee KW, Kasturi V, Chin K, von Heydebreck A, Gulley JL. Avelumab in patients with previously treated metastatic melanoma: phase 1b results from the JAVELIN Solid Tumor trial. J Immunother Cancer. 2019 Jan 16;7(1):12. doi: 10.1186/s40425-018-0459-y.
Hassan R, Thomas A, Nemunaitis JJ, Patel MR, Bennouna J, Chen FL, Delord JP, Dowlati A, Kochuparambil ST, Taylor MH, Powderly JD, Vaishampayan UN, Verschraegen C, Grote HJ, von Heydebreck A, Chin K, Gulley JL. Efficacy and Safety of Avelumab Treatment in Patients With Advanced Unresectable Mesothelioma: Phase 1b Results From the JAVELIN Solid Tumor Trial. JAMA Oncol. 2019 Mar 1;5(3):351-357. doi: 10.1001/jamaoncol.2018.5428.
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Patel MR, Ellerton J, Infante JR, Agrawal M, Gordon M, Aljumaily R, Britten CD, Dirix L, Lee KW, Taylor M, Schoffski P, Wang D, Ravaud A, Gelb AB, Xiong J, Rosen G, Gulley JL, Apolo AB. Avelumab in metastatic urothelial carcinoma after platinum failure (JAVELIN Solid Tumor): pooled results from two expansion cohorts of an open-label, phase 1 trial. Lancet Oncol. 2018 Jan;19(1):51-64. doi: 10.1016/S1470-2045(17)30900-2. Epub 2017 Dec 5.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Avelumab (anti-PD-L1) as first-line switch-maintenance or second-line therapy in patients with advanced gastric or gastroesophageal junction cancer: phase 1b results from the JAVELIN Solid Tumor trial
Other Identifiers
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2013-002834-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EMR 100070-001
Identifier Type: -
Identifier Source: org_study_id