Back to resultsBemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer (FORTITUDE-102)
Primary Purpose
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bemarituzumab
Nivolumab
Chemotherapy
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Bemarituzumab, AMG 552, 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6), Nivolumab, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, FGFR2b Overexpression, Capecitabine and Oxaliplatin (CAPOX)
Eligibility Criteria
Inclusion Criteria Part 1 and Part 2:
- Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
- Participant has no contraindications to mFOLFOX6 chemotherapy or nivolumab
Adequate organ function as follows:
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
- Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) <3 x upper limit of normal (ULN) (or < 5 x ULN if liver involvement)
- Total bilirubin <1.5 x ULN (or < 2 x ULN if liver involvement or Gilbert's disease)
- Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/minute calculated using the formula of Cockcroft and Gault
- International Normalized Ratio (INR) or prothrombin time (PT) < 1.5 × ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
Additional Inclusion Criteria Part 2:
- No prior treatment for metastatic or unresectable disease except for a maximum of 1 dose of mFOLFOX6 with or without nivolumab. Prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment
- Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive as determined by centrally performed immunohistochemistry (IHC) testing based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy.
Exclusion Criteria:
- Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
- Known positive human epidermal growth factor receptor 2 (HER2) status
- Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease
- Peripheral sensory neuropathy grade 2 or higher
- Clinically significant cardiac disease
- Other malignancy within the last 2 years (exceptions for definitively treated disease)
- Chronic or systemic ophthalmologic disorders
- Major surgery or other investigational study within 28 days prior to randomization
- Palliative radiotherapy within 14 days prior to randomization
- Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
- Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
Sites / Locations
- Mayo Clinic - ArizonaRecruiting
- The Oncology Institute Clinical ResearchRecruiting
- Cancer and Blood Specialty ClinicRecruiting
- City of Hope National Medical CenterRecruiting
- University of California Los AngelesRecruiting
- University of California IrvineRecruiting
- Torrance Memorial Physician NetworkRecruiting
- Translational Research in Oncology - US IncRecruiting
- Translational Research in Oncology US Inc, Trio Central PharmacyRecruiting
- Olive View-University of California in Los Angeles Medical CenterRecruiting
- Presbyterian Intercommunity Hospital Health Whitter HospitalRecruiting
- Florida Cancer Specialists - Fort MyersRecruiting
- Mayo Clinic FloridaRecruiting
- Adventist Health System/Sunbelt, Inc d/b/a AdventHealth OrlandoRecruiting
- Orlando Health Cancer InstituteRecruiting
- Greater Baltimore Medical CenterRecruiting
- Henry Ford Health SystemRecruiting
- Mayo Clinic RochesterRecruiting
- Summit Medical GroupRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Stony Brook University Medical CenterRecruiting
- FirstHealth Cancer CenterRecruiting
- Gabrail Cancer Center, LLCRecruiting
- Providence Portland Medical CenterRecruiting
- Saint Lukes University Health NetworkRecruiting
- Medical University of South Carolina, Hollings Cancer CenterRecruiting
- The West Clinic, PLLCRecruiting
- Sarah Cannon Research InstituteRecruiting
- Texas Oncology - Austin MidtownRecruiting
- University of Texas MD Anderson Cancer CenterRecruiting
- United States Oncology Regulatory Affairs Corporate OfficeRecruiting
- US Oncology Research Investigational Products CenterRecruiting
- Virginia Oncology AssociatesRecruiting
- Northwest Cancer Specialists - VancouverRecruiting
- Aurora Health Care Metro IncRecruiting
- CemicRecruiting
- Hospital Italiano de La PlataRecruiting
- Centro Medico AustralRecruiting
- Fundacion Ars MedicaRecruiting
- Clinica ViedmaRecruiting
- Fundacion RespirarRecruiting
- Hospital ItalianoRecruiting
- Sanatorio AllendeRecruiting
- Centro Oncologico Riojano IntegralRecruiting
- GenesisCare -North Shore OncologyRecruiting
- The Queen Elizabeth HospitalRecruiting
- Ballarat Health ServicesRecruiting
- Austin Health, Austin HospitalRecruiting
- Medizinische Universitaet GrazRecruiting
- Medizinische Universitaet InnsbruckRecruiting
- Landeskrankenhaus FeldkirchRecruiting
- Landeskrankenhaus SalzburgRecruiting
- Krankenhaus Wiener NeustadtRecruiting
- Universitaetsklinikum Allgemeines Krankenhaus WienRecruiting
- Universite Catholique de Louvain Cliniques Universitaires Saint LucRecruiting
- Grand Hopital de CharleroiRecruiting
- Universitair Ziekenhuis AntwerpenRecruiting
- Universitair Ziekenhuis GentRecruiting
- Universitair Ziekenhuis BrusselRecruiting
- Universitair Ziekenhuis Leuven - Campus GasthuisbergRecruiting
- Centre Hospitalier de l ArdenneRecruiting
- Centre Hospitalier Universitaire de Liege - Sart TilmanRecruiting
- Hospital Haroldo Juacaba - Instituto do Cancer do CearaRecruiting
- Hospital Sirio LibanesRecruiting
- Personal Oncologia de Precisao e PersonalizadaRecruiting
- Liga Norte-Riograndense Contra O CancerRecruiting
- Hospital de Clinicas de Porto AlegreRecruiting
- Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de DeusRecruiting
- Fundacao Pio 12 Hospital de Amor de BarretosRecruiting
- Instituto do Cancer Arnaldo Vieira de CarvalhoRecruiting
- Sociedade Beneficente de Senhoras Hospital Sirio LibanesRecruiting
- AC Camargo Cancer CenterRecruiting
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio PretoRecruiting
- Instituto CoiRecruiting
- Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira IcespRecruiting
- Complex Oncology Center - BurgasRecruiting
- Multiprofile Hospital for Active Treatment - Uni Hospital OODRecruiting
- Multiprofile Hospital for Active Treatment Central Onco Hospital OODRecruiting
- Military Medical Academy Multiprofile Hospital for Active Treatment - SofiaRecruiting
- London Health Sciences CentreRecruiting
- Princess Margaret Cancer CentreRecruiting
- Centre Hospitalier de L Universite de MontrealRecruiting
- CHU de Quebec Hopital de l Enfant JesusRecruiting
- Centro De Estudios Clínicos Suecia SpARecruiting
- Oncocentro ApysRecruiting
- IC La Serena ResearchRecruiting
- OncovidaRecruiting
- IcegclinicRecruiting
- Fakultni nemocnice Hradec KraloveRecruiting
- Fakultni nemocnice OlomoucRecruiting
- Fakultni nemocnice Kralovske VinohradyRecruiting
- Vseobecna fakultni nemocnice v PrazeRecruiting
- Fakultni Thomayerova nemocniceRecruiting
- Centre Hospitalier Universitaire Amiens Picardie - Hopital SudRecruiting
- Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean MinjozRecruiting
- Institut BergonieRecruiting
- Centre Hospitalier Universitaire de BrestRecruiting
- Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital EstaingRecruiting
- Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude HuriezRecruiting
- Centre Hospitalier Universitaire de Limoges - Hopital DupuytrenRecruiting
- Centre Leon BerardRecruiting
- Centre Antoine LacassagneRecruiting
- Hôpital Saint LouisRecruiting
- Hôpital Européen Georges PompidouRecruiting
- Centre Hospitalier Universitaire de RouenRecruiting
- Centre Rene Gauducheau - Institut de Cancerologie de l OuestRecruiting
- Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital NordRecruiting
- Institut de cancerologie Strasbourg EuropeRecruiting
- Centre Hospitalier Universitaire de Toulouse - Hopital RangueilRecruiting
- Institut Gustave RoussyRecruiting
- Charite - Universitaetsmedizin Berlin, Campus VirchowRecruiting
- Universitaetsklinikum DresdenRecruiting
- Krankenhaus Nordwest GmbHRecruiting
- Medizinische Hochschule HannoverRecruiting
- Universitaetsklinikum Schleswig-HolsteinRecruiting
- Universitaetsklinikum LeipzigRecruiting
- Regional Kliniken Holding Klinikum LudwigsburgRecruiting
- Johannes Gutenberg Universitaet MainzRecruiting
- Universitaetsmedizin MannheimRecruiting
- Klinikum der LMU MuenchenRecruiting
- Klinikum rechts der Isar der TUMRecruiting
- Universitaetsklinikum der Eberhard Karls Universitaet TuebingenRecruiting
- Universitaetsklinikum UlmRecruiting
- Klinikum der Stadt WolfsburgRecruiting
- Prince of Wales HospitalRecruiting
- Semmelweis EgyetemRecruiting
- Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai IntezetRecruiting
- Orszagos Onkologiai IntezetRecruiting
- Debreceni Egyetem Klinikai KozpontRecruiting
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-RendelointezetRecruiting
- Komarom-Esztergom Varmegyei Szent Borbala KorhazRecruiting
- Rambam Health Care CampusRecruiting
- Shaare Zedek Medical CenterRecruiting
- Hadassah Ein-Kerem Medical CenterRecruiting
- Sheba Medical CenterRecruiting
- Tel-Aviv Sourasky Medical CenterRecruiting
- Azienda Ospedaliero Universitaria Ospedali Riuniti di AnconaRecruiting
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIRecruiting
- Ente Ospedaliero IRCCS Saverio De BellisRecruiting
- Azienda Socio Sanitaria Territoriale di CremonaRecruiting
- Azienda Ospedaliera Universitaria CareggiRecruiting
- Ospedale Policlinico San Martino IRCCSRecruiting
- IRCCS Ospedale San RaffaeleRecruiting
- Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
- Azienda Ospedaliero Universitaria Luigi VanvitelliRecruiting
- Istituto Oncologico Veneto IRCCSRecruiting
- Azienda Ospedaliera Universitaria Pisana Ospedale Santa ChiaraRecruiting
- Nagoya University HospitalRecruiting
- Chiba Cancer CenterRecruiting
- National Cancer Center Hospital EastRecruiting
- National Hospital Organization Shikoku Cancer CenterRecruiting
- National Hospital Organization Kyushu Cancer CenterRecruiting
- Gifu University HospitalRecruiting
- Hokkaido University HospitalRecruiting
- Hyogo Cancer CenterRecruiting
- Kobe City Medical Center General HospitalRecruiting
- Yokohama City University Medical CenterRecruiting
- Kanagawa Prefectural Hospital Organization Kanagawa Cancer CenterRecruiting
- Niigata Cancer Center HospitalRecruiting
- Kansai Medical University HospitalRecruiting
- Osaka International Cancer InstituteRecruiting
- Kindai University HospitalRecruiting
- Osaka University HospitalRecruiting
- Saitama Cancer CenterRecruiting
- Shizuoka Cancer CenterRecruiting
- National Cancer Center HospitalRecruiting
- The Cancer Institute Hospital of Japanese Foundation for Cancer ResearchRecruiting
- Kyungpook National University Chilgok HospitalRecruiting
- Chungnam National University HospitalRecruiting
- Jeonbuk National University HospitalRecruiting
- Seoul National University Bundang HospitalRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- Kangbuk Samsung HospitalRecruiting
- Severance Hospital Yonsei University Health SystemRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- The Catholic University of Korea Seoul St Marys HospitalRecruiting
- Korea University Guro HospitalRecruiting
- Narodowy Instytut Onkologii im M Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w GliwicachRecruiting
- Przychodnia Lekarska Komed Roman KaraszewskiRecruiting
- Samodzielny Publiczny Szpital Kliniczny Nr 1Recruiting
- Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzooRecruiting
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w SzczecinieRecruiting
- Lux med onkologia sp zoo szpital szamockaRecruiting
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we WroclawiuRecruiting
- Hospital de Braga, EPERecruiting
- Hospital da Luz, SARecruiting
- Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa MariaRecruiting
- Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro HispanoRecruiting
- Centro Hospitalar Universitario de Sao Joao, EPE - Hospital de Sao JoaoRecruiting
- Institutul Clinic FundeniRecruiting
- Institutul Oncologic Prof Dr Ion Chiricuta Cluj-NapocaRecruiting
- Institutul Regional de Gastroenterologie si Hepatologie " Prof Dr Octavian Fodor"Recruiting
- Centrul de Oncologie Sf Nectarie SRLRecruiting
- Institutul Regional de Oncologie IasiRecruiting
- SC Oncomed SRLRecruiting
- National University HospitalRecruiting
- National Cancer Centre SingaporeRecruiting
- Hospital Universitario Virgen del RocioRecruiting
- Hospital Universitario Central de AsturiasRecruiting
- Hospital Universitario Marques de ValdecillaRecruiting
- Hospital del MarRecruiting
- Hospital Universitari Vall d HebronRecruiting
- Institut Catala d Oncologia Hospitalet Hospital Duran i ReynalsRecruiting
- Hospital General Universitario de ElcheRecruiting
- Hospital Clinico Universitario de ValenciaRecruiting
- Complexo Hospitalario Universitario A Coruña Hospital Teresa HerreraRecruiting
- Hospital Universitario de NavarraRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- Hospital Clinico San CarlosRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
- China Medical University HospitalRecruiting
- National Cheng Kung University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- Tri-Service General HospitalRecruiting
- Chulabhorn HospitalRecruiting
- Maharaj Nakorn Chiang Mai HospitalRecruiting
- Chiangrai Prachanukroh HospitalRecruiting
- Prince of Songkla HospitalRecruiting
- Addenbrookes HospitalRecruiting
- University Hospital CoventryRecruiting
- Ninewells Hospital and Medical SchoolRecruiting
- Guys HospitalRecruiting
- Christie HospitalRecruiting
- Mount Vernon Cancer CentreRecruiting
- Torbay HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and Nivolumab
Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab
Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab
Arm Description
Participants will be administered bemarituzumab at different doses with mFOLFOX6 and nivolumab to determine the recommended phase 3 dose (RP3D) based on occurrence of dose-limiting toxicities (DLTs), and on an evaluation of the overall safety, tolerability, and pharmacokinetics (PK).
Participants will be administered bemarituzumab at the RP3D determined from Part 1 in combination with mFOLFOX6 and nivolumab on a 14-day cycle. Or participants will be administered bemarituzumab in combination with CAPOX and nivolumab on a 21-day cycle.
Participants will be administered placebo comparator in combination with mFOLFOX6 and nivolumab on a 14-day cycle. Or participants will be administered placebo comparator in combination with CAPOX and nivolumab on a 21-day cycle.
Outcomes
Primary Outcome Measures
Part 1: Number of Participants Who Experienced DLTs
Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
Part 1: Number of Participants Who Experienced One or More Related TEAEs
Part 1: Number of Participants With Clinically Significant Changes in Vital Signs
Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity
Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations
Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Secondary Outcome Measures
Part 1: Objective Response (OR)
Part 1: Duration of Response (DoR)
Part 1: Disease Control Rate (DCR)
Part 1: Progression Free Survival (PFS)
Part 1: Overall Survival
Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab
Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
Part 1: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
Part 1: Number of Participants With Anti-Bemarituzumab Antibody Formation
Part 2: PFS in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: OR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: Number of Participants Who Experienced One or More TEAEs
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs
Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity
Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Part 2: Overall Survival in All Randomized Participants
Part 2: PFS in All Randomized Participants
Part 2: Objective Response Rate (ORR) in All Randomized Participants
Part 2: DoR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: DCR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: Mean Score in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Version 3.0 (QLQ-C30) Individual Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: Change From Baseline in EORTC QLQ-C30 Individual Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: Mean Score in Stomach Cancer Related Symptoms Measured by EORTC Quality of Life Questionnaire-Stomach 22 (QLQ-STO22) in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: Change From Baseline in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: Mean Score of Visual Analogue Scale (VAS) Scores as Measured by EuroQol 5-dimensional (EQ-5D-5L) in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: Change From Baseline of VAS Scores as Measured by EQ-5D-5L in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: Time to Deterioration in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: Time to Deterioration in Health-Related Quality of Life (HRQoL) Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: Time to Deterioration in Physical Function Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Part 2: Cmax of Bemarituzumab
Part 2: Ctrough of Bemarituzumab
Part 2: Number of Participants With Anti-Bemarituzumab Antibody Formation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05111626
Brief Title
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer
Acronym
FORTITUDE-102
Official Title
A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
September 26, 2026 (Anticipated)
Study Completion Date
September 26, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.
The main objective Part 2 is to compare efficacy of bemarituzumab plus chemotherapy (mFOLFOX6 or capecitabine combined with oxaliplatin (CAPOX)) and nivolumab to placebo plus chemotherapy (mFOLFOX6 or CAPOX) and nivolumab as assessed by overall survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Keywords
Bemarituzumab, AMG 552, 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6), Nivolumab, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, FGFR2b Overexpression, Capecitabine and Oxaliplatin (CAPOX)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Model Description
This is a Phase 1b/3 study:
Phase 1b (Part 1) is a single-arm open-label study, which will enroll about 20 participants
Phase 3 (Part 2) is a randomized double-blind 2-arm study, which will enroll 508 participants
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
528 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and Nivolumab
Arm Type
Experimental
Arm Description
Participants will be administered bemarituzumab at different doses with mFOLFOX6 and nivolumab to determine the recommended phase 3 dose (RP3D) based on occurrence of dose-limiting toxicities (DLTs), and on an evaluation of the overall safety, tolerability, and pharmacokinetics (PK).
Arm Title
Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab
Arm Type
Experimental
Arm Description
Participants will be administered bemarituzumab at the RP3D determined from Part 1 in combination with mFOLFOX6 and nivolumab on a 14-day cycle.
Or participants will be administered bemarituzumab in combination with CAPOX and nivolumab on a 21-day cycle.
Arm Title
Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab
Arm Type
Placebo Comparator
Arm Description
Participants will be administered placebo comparator in combination with mFOLFOX6 and nivolumab on a 14-day cycle.
Or participants will be administered placebo comparator in combination with CAPOX and nivolumab on a 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Bemarituzumab
Other Intervention Name(s)
AMG 552
Intervention Description
Bemarituzumab will be administered as intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Intervention Description
Nivolumab will be administered as IV infusion.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
mFOLFOX6: 5-fluorouracil, leucovorin, and oxaliplatin will be administered as IV infusion.
OR CAPOX: oxaliplatin will be administered as IV infusion and capecitabine will be administered orally.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as IV infusion.
Primary Outcome Measure Information:
Title
Part 1: Number of Participants Who Experienced DLTs
Time Frame
28 days
Title
Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
Time Frame
Up to 4.5 years
Title
Part 1: Number of Participants Who Experienced One or More Related TEAEs
Time Frame
Up to 4.5 years
Title
Part 1: Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame
Up to 4.5 years
Title
Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity
Time Frame
Up to 4.5 years
Title
Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations
Time Frame
Up to 4.5 years
Title
Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time Frame
Up to 4.5 years
Title
Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Up to 4.5 years
Secondary Outcome Measure Information:
Title
Part 1: Objective Response (OR)
Time Frame
Up to 4.5 years
Title
Part 1: Duration of Response (DoR)
Time Frame
Up to 4.5 years
Title
Part 1: Disease Control Rate (DCR)
Time Frame
Up to 4.5 years
Title
Part 1: Progression Free Survival (PFS)
Time Frame
Up to 4.5 years
Title
Part 1: Overall Survival
Time Frame
Up to 4.5 years
Title
Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab
Time Frame
Day 1 to up to 4.5 years
Title
Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
Time Frame
Day 1 to up to 4.5 years
Title
Part 1: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
Time Frame
Day 1 to up to 4.5 years
Title
Part 1: Number of Participants With Anti-Bemarituzumab Antibody Formation
Time Frame
Day 1 to up to 4.5 years
Title
Part 2: PFS in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Up to 4.5 years
Title
Part 2: OR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Up to 4.5 years
Title
Part 2: Number of Participants Who Experienced One or More TEAEs
Time Frame
Up to 4.5 years
Title
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame
Up to 4.5 years
Title
Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity
Time Frame
Up to 4.5 years
Title
Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time Frame
Up to 4.5 years
Title
Part 2: Overall Survival in All Randomized Participants
Time Frame
Up to 4.5 years
Title
Part 2: PFS in All Randomized Participants
Time Frame
Up to 4.5 years
Title
Part 2: Objective Response Rate (ORR) in All Randomized Participants
Time Frame
Up to 4.5 years
Title
Part 2: DoR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Up to 4.5 years
Title
Part 2: DCR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Up to 4.5 years
Title
Part 2: Mean Score in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Version 3.0 (QLQ-C30) Individual Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Up to 4.5 years
Title
Part 2: Change From Baseline in EORTC QLQ-C30 Individual Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Baseline to up to 4.5 years
Title
Part 2: Mean Score in Stomach Cancer Related Symptoms Measured by EORTC Quality of Life Questionnaire-Stomach 22 (QLQ-STO22) in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Up to 4.5 years
Title
Part 2: Change From Baseline in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Baseline to up to 4.5 years
Title
Part 2: Mean Score of Visual Analogue Scale (VAS) Scores as Measured by EuroQol 5-dimensional (EQ-5D-5L) in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Up to 4.5 years
Title
Part 2: Change From Baseline of VAS Scores as Measured by EQ-5D-5L in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Baseline to up to 4.5 years
Title
Part 2: Time to Deterioration in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Day 1 to up to 4.5 years
Title
Part 2: Time to Deterioration in Health-Related Quality of Life (HRQoL) Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Day 1 to up to 4.5 years
Title
Part 2: Time to Deterioration in Physical Function Scores in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants
Time Frame
Day 1 to up to 4.5 years
Title
Part 2: Cmax of Bemarituzumab
Time Frame
Day 1 to up to 4.5 years
Title
Part 2: Ctrough of Bemarituzumab
Time Frame
Day 1 to up to 4.5 years
Title
Part 2: Number of Participants With Anti-Bemarituzumab Antibody Formation
Time Frame
Day 1 to up to 4.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Part 1 and Part 2:
Adult with unresectable, locally advanced or metastatic (not amenable to curative therapy) histologically documented gastric or gastroesophageal junction adenocarcinoma
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Measurable disease or non-measurable, but evaluable disease, according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1)
Participant has no contraindications to nivolumab and either mFOLFOX6 or CAPOX chemotherapy as per local prescribing information. Participants in Part 1 must have no contraindications to mFOLFOX6. Participants in Part 2 with contraindications to mFOLFOX6 are permitted and may be administered the CAPOX regimen, if no contraindications for this regimen exist. Participants in Part 2 with contraindications to CAPOX are permitted and may be administered the mFOLFOX6 regimen, if no contraindications for this regimen exist
Adequate organ function as follows:
Absolute neutrophil count ≥ 1.5 x 10^9/L
Platelet count ≥ 100 x 10^9/L
Hemoglobin ≥ 9 g/dL without red blood cell (RBC) transfusion within 7 days prior to the first dose of study treatment
Aspartate aminotransaminase (AST) and Alanine aminotransaminase (ALT) <3 x upper limit of normal (ULN) (or < 5 x ULN if liver involvement)
Total bilirubin <1.5 x ULN (or < 2 x ULN if liver involvement or Gilbert's disease)
Part 1 only: Calculated or measured creatinine clearance (CrCl) of ≥ 50 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age] × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female).
Part 2 only: Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute calculated using the formula of Cockcroft and Gault ([140 - Age] × Mass [kg]/[72 × Creatinine mg/dL]) (x 0.85 if female).
INR or prothrombin time (PT) < 1.5 × ULN except for participants receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to enrollment
Additional Inclusion Criteria Part 2:
No prior treatment for metastatic or unresectable disease except for a maximum of
1 dose of chemotherapy with or without nivolumab; prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment
Fibroblast growth factor receptor 2b (FGFR2b) ≥ 10% 2+/3+ tumor cells (TC) as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy.
Exclusion Criteria:
Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
Known positive human epidermal growth factor receptor 2 (HER2) status
Untreated or symptomatic central nervous system disease metastases and leptomeningeal disease
Peripheral sensory neuropathy grade 2 or higher
Clinically significant cardiac disease
Other malignancy within the last 2 years (exceptions for definitively treated disease)
Chronic or systemic ophthalmologic disorders
Major surgery or other investigational study within 28 days prior to randomization
Palliative radiotherapy within 14 days prior to randomization
Abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amgen Call Center
Phone
866-572-6436
Email
medinfo@amgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic - Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Name
The Oncology Institute Clinical Research
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer and Blood Specialty Clinic
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Torrance Memorial Physician Network
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Individual Site Status
Recruiting
Facility Name
Translational Research in Oncology - US Inc
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Translational Research in Oncology US Inc, Trio Central Pharmacy
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
Olive View-University of California in Los Angeles Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Individual Site Status
Recruiting
Facility Name
Presbyterian Intercommunity Hospital Health Whitter Hospital
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists - Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando Health Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Summit Medical Group
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-7263
Country
United States
Individual Site Status
Recruiting
Facility Name
FirstHealth Cancer Center
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Individual Site Status
Recruiting
Facility Name
Gabrail Cancer Center, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Lukes University Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical University of South Carolina, Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
The West Clinic, PLLC
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
United States Oncology Regulatory Affairs Corporate Office
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Name
US Oncology Research Investigational Products Center
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Cancer Specialists - Vancouver
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Individual Site Status
Recruiting
Facility Name
Aurora Health Care Metro Inc
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Individual Site Status
Recruiting
Facility Name
Cemic
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano de La Plata
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Medico Austral
City
Ciudad Autónoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
C1019ABS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion Ars Medica
City
San Salvador de Jujuy
State/Province
Jujuy
ZIP/Postal Code
4600
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clinica Viedma
City
Viedma
State/Province
Río Negro
ZIP/Postal Code
8500
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion Respirar
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano
City
Capital Federal
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Allende
City
Córdoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Oncologico Riojano Integral
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
GenesisCare -North Shore Oncology
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Individual Site Status
Recruiting
Facility Name
Ballarat Health Services
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health, Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universitaet Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Landeskrankenhaus Feldkirch
City
Rankweil
ZIP/Postal Code
6830
Country
Austria
Individual Site Status
Recruiting
Facility Name
Landeskrankenhaus Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Krankenhaus Wiener Neustadt
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Allgemeines Krankenhaus Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Grand Hopital de Charleroi
City
Charleroi
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de l Ardenne
City
Libramont
ZIP/Postal Code
6800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Liege - Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Hospital Haroldo Juacaba - Instituto do Cancer do Ceara
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-230
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sirio Libanes
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70200-730
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Personal Oncologia de Precisao e Personalizada
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Liga Norte-Riograndense Contra O Cancer
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59075-740
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-003
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90110-270
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Pio 12 Hospital de Amor de Barretos
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto do Cancer Arnaldo Vieira de Carvalho
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01308-050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
AC Camargo Cancer Center
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01509-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
City
São José do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Coi
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp
City
São Paulo
ZIP/Postal Code
04501-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Complex Oncology Center - Burgas
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment - Uni Hospital OOD
City
Panagyurishte
ZIP/Postal Code
4500
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment Central Onco Hospital OOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 2C1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de L Universite de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU de Quebec Hopital de l Enfant Jesus
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centro De Estudios Clínicos Suecia SpA
City
Santiago de Chile
State/Province
Santiago
ZIP/Postal Code
7510062
Country
Chile
Individual Site Status
Recruiting
Facility Name
Oncocentro Apys
City
Viña del Mar
State/Province
Valparaíso
ZIP/Postal Code
2520598
Country
Chile
Individual Site Status
Recruiting
Facility Name
IC La Serena Research
City
La Serena
ZIP/Postal Code
1720430
Country
Chile
Individual Site Status
Recruiting
Facility Name
Oncovida
City
Santiago
ZIP/Postal Code
7510032
Country
Chile
Individual Site Status
Recruiting
Facility Name
Icegclinic
City
Santiago
ZIP/Postal Code
8241479
Country
Chile
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni Thomayerova nemocnice
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Brest
City
Brest
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing
City
Clermont-Ferrand cedex 1
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Leon Berard
City
Lyon cedex 8
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Rouen
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Rene Gauducheau - Institut de Cancerologie de l Ouest
City
Saint Herblain
ZIP/Postal Code
44800
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Individual Site Status
Recruiting
Facility Name
Institut de cancerologie Strasbourg Europe
City
Strasbourg cedex
ZIP/Postal Code
67065
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Charite - Universitaetsmedizin Berlin, Campus Virchow
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Krankenhaus Nordwest GmbH
City
Frankfurt am Main
ZIP/Postal Code
60488
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Regional Kliniken Holding Klinikum Ludwigsburg
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
Individual Site Status
Recruiting
Facility Name
Johannes Gutenberg Universitaet Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der LMU Muenchen
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum rechts der Isar der TUM
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der Stadt Wolfsburg
City
Wolfsburg
ZIP/Postal Code
38440
Country
Germany
Individual Site Status
Recruiting
Facility Name
Prince of Wales Hospital
City
Shatin, New Territories
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Orszagos Onkologiai Intezet
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Ein-Kerem Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ente Ospedaliero IRCCS Saverio De Bellis
City
Castellana Grotte
ZIP/Postal Code
70013
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Policlinico San Martino IRCCS
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Oncologico Veneto IRCCS
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba Cancer Center
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gifu University Hospital
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
501-1194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hyogo Cancer Center
City
Akashi-shi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe City Medical Center General Hospital
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata Cancer Center Hospital
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kansai Medical University Hospital
City
Hirakata-shi
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka University Hospital
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Cancer Center
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Jeonbuk National University Hospital
City
Jeonju-si, Jeollabuk-do
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea Seoul St Marys Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Narodowy Instytut Onkologii im M Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach
City
Gliwice
ZIP/Postal Code
44-102
Country
Poland
Individual Site Status
Recruiting
Facility Name
Przychodnia Lekarska Komed Roman Karaszewski
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1
City
Lublin
ZIP/Postal Code
20-080
Country
Poland
Individual Site Status
Recruiting
Facility Name
Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Recruiting
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Individual Site Status
Recruiting
Facility Name
Lux med onkologia sp zoo szpital szamocka
City
Warszawa
ZIP/Postal Code
01-748
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital de Braga, EPE
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital da Luz, SA
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitario de Sao Joao, EPE - Hospital de Sao Joao
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Institutul Clinic Fundeni
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
City
Cluj Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Name
Institutul Regional de Gastroenterologie si Hepatologie " Prof Dr Octavian Fodor"
City
Cluj-Napoca
ZIP/Postal Code
400000
Country
Romania
Individual Site Status
Recruiting
Facility Name
Centrul de Oncologie Sf Nectarie SRL
City
Craiova
ZIP/Postal Code
200542
Country
Romania
Individual Site Status
Recruiting
Facility Name
Institutul Regional de Oncologie Iasi
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Individual Site Status
Recruiting
Facility Name
SC Oncomed SRL
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
State/Province
Andalucía
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital del Mar
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d Hebron
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
City
Hospitalet de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Comunidad Valenciana
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera
City
A Coruña
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chulabhorn Hospital
City
Bangkok
ZIP/Postal Code
10210
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Chiangrai Prachanukroh Hospital
City
Chiang Rai
ZIP/Postal Code
57000
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Prince of Songkla Hospital
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Ninewells Hospital and Medical School
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Mount Vernon Cancer Centre
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Torbay Hospital
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer
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