History of Changes for Study: NCT05111626

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer (FORTITUDE-102)

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Study Record Versions

Version	Submitted Date	Changes
1	October 29, 2021	None (earliest Version on record)
2	December 2, 2021	Study Status and Contacts/Locations
3	January 6, 2022	Study Status and Contacts/Locations
4	February 28, 2022	Study Status and Contacts/Locations
5	March 17, 2022	Recruitment Status, Contacts/Locations and Study Status
6	April 13, 2022	Study Status and Contacts/Locations
7	April 20, 2022	Contacts/Locations and Study Status
8	May 24, 2022	Study Status, Contacts/Locations and Eligibility
9	July 6, 2022	Study Status and Contacts/Locations
10	August 8, 2022	Study Status, Contacts/Locations and Study Design
11	September 1, 2022	Study Status and Contacts/Locations
12	September 7, 2022	Contacts/Locations and Study Status
13	September 14, 2022	Study Status and Contacts/Locations
14	September 21, 2022	Contacts/Locations and Study Status
15	September 28, 2022	Contacts/Locations and Study Status
16	October 18, 2022	Outcome Measures, Study Status, Contacts/Locations and Eligibility
17	October 26, 2022	Contacts/Locations and Study Status
18	November 2, 2022	Study Status and Contacts/Locations
19	November 16, 2022	Contacts/Locations and Study Status
20	December 7, 2022	Contacts/Locations and Study Status
21	January 4, 2023	Contacts/Locations and Study Status
22	January 26, 2023	Outcome Measures, Study Design, Contacts/Locations, Eligibility and Study Status
23	February 1, 2023	Study Status and Contacts/Locations
24	February 8, 2023	Contacts/Locations and Study Status
25	February 15, 2023	Contacts/Locations and Study Status
26	February 22, 2023	Contacts/Locations and Study Status
27	March 1, 2023	Study Status and Contacts/Locations
28	March 22, 2023	Contacts/Locations and Study Status
29	April 5, 2023	Study Status and Contacts/Locations
30	April 19, 2023	Contacts/Locations and Study Status
31	May 10, 2023	Contacts/Locations and Study Status
32	May 17, 2023	Contacts/Locations and Study Status
33	May 24, 2023	Contacts/Locations and Study Status
34	May 31, 2023	Contacts/Locations and Study Status
35	June 14, 2023	Contacts/Locations and Study Status
36	June 28, 2023	Contacts/Locations and Study Status
37	July 12, 2023	Contacts/Locations and Study Status
38	August 9, 2023	Contacts/Locations and Study Status
39	August 16, 2023	Study Status and Contacts/Locations
40	September 6, 2023	Study Status and Contacts/Locations
41	September 18, 2023	Arms and Interventions, Contacts/Locations, Eligibility, Outcome Measures, Study Design, Conditions, Study Description and Study Status
42	September 27, 2023	Contacts/Locations and Study Status
43	October 4, 2023	Study Status and Contacts/Locations
44	October 12, 2023	Contacts/Locations and Study Status
45	October 26, 2023	Contacts/Locations and Study Status
46	November 1, 2023	Study Status and Contacts/Locations
47	November 15, 2023	Contacts/Locations and Study Status
48	November 22, 2023	Contacts/Locations and Study Status
49	December 6, 2023	Study Status and Contacts/Locations
50	December 20, 2023	Contacts/Locations and Study Status
51	January 3, 2024	Contacts/Locations and Study Status
52	January 10, 2024	Contacts/Locations and Study Status
53	January 25, 2024	Contacts/Locations and Study Status
54	February 7, 2024	Contacts/Locations and Study Status
55	February 21, 2024	Contacts/Locations and Study Status
56	February 28, 2024	Contacts/Locations and Study Status
57	March 7, 2024	Contacts/Locations, Study Status and Study Identification
58	March 13, 2024	Contacts/Locations and Study Status
59	March 20, 2024	Contacts/Locations and Study Status
60	March 27, 2024	Contacts/Locations and Study Status
61	April 30, 2024	Contacts/Locations and Study Status
62	May 15, 2024	Study Status and Contacts/Locations
63	May 22, 2024	Contacts/Locations and Study Status
64	May 29, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	20210098
Brief Title:	Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer (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
Secondary IDs:

Study Status


Record Verification:	February 2024
Overall Status:	Recruiting
Study Start:	March 14, 2022
Primary Completion:	September 26, 2026 [Anticipated]
Study Completion:	September 26, 2026 [Anticipated]

First Submitted:	October 29, 2021
First Submitted that Met QC Criteria:	October 29, 2021
First Posted:	November 8, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	February 21, 2024
Last Update Posted:	February 22, 2024 [Actual]

Sponsor/Collaborators


Sponsor:	Amgen
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.

Detailed Description:

Conditions


Conditions:	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)

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Sequential Assignment
	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
Number of Arms:	3
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	528 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and Nivolumab 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).	Drug: Bemarituzumab Bemarituzumab will be administered as intravenous (IV) infusion. Other Names: AMG 552 Drug: Nivolumab Nivolumab will be administered as IV infusion. Drug: Chemotherapy 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.
Experimental: Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab 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.	Drug: Bemarituzumab Bemarituzumab will be administered as intravenous (IV) infusion. Other Names: AMG 552 Drug: Nivolumab Nivolumab will be administered as IV infusion. Drug: Chemotherapy 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.
Placebo Comparator: Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab 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.	Drug: Nivolumab Nivolumab will be administered as IV infusion. Drug: Chemotherapy 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. Placebo Placebo will be administered as IV infusion.

Outcome Measures


Primary Outcome Measures:
1.	Part 1: Number of Participants Who Experienced DLTs [ Time Frame: 28 days ]
2.	Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 4.5 years ]
3.	Part 1: Number of Participants Who Experienced One or More Related TEAEs [ Time Frame: Up to 4.5 years ]
4.	Part 1: Number of Participants With Clinically Significant Changes in Vital Signs [ Time Frame: Up to 4.5 years ]
5.	Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity [ Time Frame: Up to 4.5 years ]
6.	Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations [ Time Frame: Up to 4.5 years ]
7.	Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [ Time Frame: Up to 4.5 years ]
8.	Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants [ Time Frame: Up to 4.5 years ]
Secondary Outcome Measures:
1.	Part 1: Objective Response (OR) [ Time Frame: Up to 4.5 years ]
2.	Part 1: Duration of Response (DoR) [ Time Frame: Up to 4.5 years ]
3.	Part 1: Disease Control Rate (DCR) [ Time Frame: Up to 4.5 years ]
4.	Part 1: Progression Free Survival (PFS) [ Time Frame: Up to 4.5 years ]
5.	Part 1: Overall Survival [ Time Frame: Up to 4.5 years ]
6.	Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab [ Time Frame: Day 1 to up to 4.5 years ]
7.	Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab [ Time Frame: Day 1 to up to 4.5 years ]
8.	Part 1: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab [ Time Frame: Day 1 to up to 4.5 years ]
9.	Part 1: Number of Participants With Anti-Bemarituzumab Antibody Formation [ Time Frame: Day 1 to up to 4.5 years ]
10.	Part 2: PFS in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants [ Time Frame: Up to 4.5 years ]
11.	Part 2: OR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants [ Time Frame: Up to 4.5 years ]
12.	Part 2: Number of Participants Who Experienced One or More TEAEs [ Time Frame: Up to 4.5 years ]
13.	Part 2: Number of Participants With Clinically Significant Changes in Vital Signs [ Time Frame: Up to 4.5 years ]
14.	Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity [ Time Frame: Up to 4.5 years ]
15.	Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [ Time Frame: Up to 4.5 years ]
16.	Part 2: Overall Survival in All Randomized Participants [ Time Frame: Up to 4.5 years ]
17.	Part 2: PFS in All Randomized Participants [ Time Frame: Up to 4.5 years ]
18.	Part 2: Objective Response Rate (ORR) in All Randomized Participants [ Time Frame: Up to 4.5 years ]
19.	Part 2: DoR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants [ Time Frame: Up to 4.5 years ]
20.	Part 2: DCR in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants [ Time Frame: Up to 4.5 years ]
21.	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 ]
22.	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 ]
23.	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 ]
24.	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 ]
25.	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 ]
26.	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 ]
27.	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 ]
28.	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 ]
29.	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 ]
30.	Part 2: Cmax of Bemarituzumab [ Time Frame: Day 1 to up to 4.5 years ]
31.	Part 2: Ctrough of Bemarituzumab [ Time Frame: Day 1 to up to 4.5 years ]
32.	Part 2: Number of Participants With Anti-Bemarituzumab Antibody Formation [ Time Frame: Day 1 to up to 4.5 years ]

Eligibility


Minimum Age:	18 Years
Maximum Age:	100 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Central Contact Person:	Amgen Call Center Telephone: 866-572-6436 Email: medinfo@amgen.com
Study Officials:	MD Study Director Amgen
Locations:	United States, Arizona
	Mayo Clinic - Arizona [Recruiting] Phoenix, Arizona, United States, 85054
	United States, California
	The Oncology Institute Clinical Research [Recruiting] Cerritos, California, United States, 90703
	Cancer and Blood Specialty Clinic [Recruiting] Downey, California, United States, 90241
	City of Hope National Medical Center [Recruiting] Duarte, California, United States, 91010
	University of California Los Angeles [Recruiting] Los Angeles, California, United States, 90095
	University of California Irvine [Recruiting] Orange, California, United States, 92868
	Torrance Memorial Physician Network [Recruiting] Redondo Beach, California, United States, 90277
	Translational Research in Oncology - US Inc [Recruiting] Santa Monica, California, United States, 90404
	Translational Research in Oncology US Inc, Trio Central Pharmacy [Recruiting] Santa Monica, California, United States, 90404
	Olive View-University of California in Los Angeles Medical Center [Recruiting] Sylmar, California, United States, 91342
	Presbyterian Intercommunity Hospital Health Whitter Hospital [Recruiting] Whittier, California, United States, 90602
	United States, Connecticut
	Yale New Haven Hospital Yale Cancer Center [Recruiting] New Haven, Connecticut, United States, 06520
	United States, Florida
	Florida Cancer Specialists - Fort Myers [Recruiting] Fort Myers, Florida, United States, 33901
	Mayo Clinic Florida [Recruiting] Jacksonville, Florida, United States, 32224
	Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando [Recruiting] Orlando, Florida, United States, 32804
	Orlando Health Cancer Institute [Recruiting] Orlando, Florida, United States, 32806
	United States, Maryland
	Greater Baltimore Medical Center [Recruiting] Baltimore, Maryland, United States, 21204
	United States, Michigan
	Henry Ford Health System [Recruiting] Detroit, Michigan, United States, 48202
	United States, Minnesota
	Mayo Clinic Rochester [Recruiting] Rochester, Minnesota, United States, 55905
	United States, New Jersey
	Summit Medical Group [Recruiting] Florham Park, New Jersey, United States, 07932
	United States, New York
	Memorial Sloan Kettering Cancer Center [Recruiting] New York, New York, United States, 10022
	Stony Brook University Medical Center [Recruiting] Stony Brook, New York, United States, 11794-7263
	United States, North Carolina
	FirstHealth Cancer Center [Recruiting] Pinehurst, North Carolina, United States, 28374
	United States, Ohio
	Gabrail Cancer Center, LLC [Recruiting] Canton, Ohio, United States, 44718
	United States, Oregon
	Providence Portland Medical Center [Recruiting] Portland, Oregon, United States, 97213
	United States, Pennsylvania
	Saint Lukes University Health Network [Recruiting] Allentown, Pennsylvania, United States, 18104
	United States, South Carolina
	Medical University of South Carolina, Hollings Cancer Center [Recruiting] Charleston, South Carolina, United States, 29425
	United States, Tennessee
	The West Clinic, PLLC [Recruiting] Germantown, Tennessee, United States, 38138
	Sarah Cannon Research Institute [Recruiting] Nashville, Tennessee, United States, 37203
	United States, Texas
	Texas Oncology - Austin Midtown [Recruiting] Austin, Texas, United States, 78705
	University of Texas MD Anderson Cancer Center [Recruiting] Houston, Texas, United States, 77030
	United States Oncology Regulatory Affairs Corporate Office [Recruiting] The Woodlands, Texas, United States, 77380
	US Oncology Research Investigational Products Center [Recruiting] The Woodlands, Texas, United States, 77380
	United States, Virginia
	Virginia Oncology Associates [Recruiting] Norfolk, Virginia, United States, 23502
	United States, Washington
	Northwest Cancer Specialists - Vancouver [Recruiting] Vancouver, Washington, United States, 98684
	United States, Wisconsin
	Aurora Health Care Metro Inc [Recruiting] Milwaukee, Wisconsin, United States, 53215
	Argentina
	Fundacion Respirar [Recruiting] Buenos Aires, Argentina, C1426ABP
	Hospital Italiano [Recruiting] Capital Federal, Argentina, C1199ABB
	Sanatorio Allende [Recruiting] Córdoba, Argentina, X5000JHQ
	Centro Oncologico Riojano Integral [Recruiting] La Rioja, Argentina, F5300COE
	Argentina, Buenos Aires
	Cemic [Recruiting] Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1431FWO
	Hospital Italiano de La Plata [Recruiting] La Plata, Buenos Aires, Argentina, 1900
	Argentina, Distrito Federal
	Centro Medico Austral [Recruiting] Ciudad Autónoma de Buenos Aires, Distrito Federal, Argentina, C1019ABS
	Argentina, Jujuy
	Fundacion Ars Medica [Recruiting] San Salvador de Jujuy, Jujuy, Argentina, 4600
	Argentina, Río Negro
	Clinica Viedma [Recruiting] Viedma, Río Negro, Argentina, 8500
	Argentina, Tucuman
	Exelsus Oncologia Clinica [Recruiting] San Miguel de Tucuman, Tucuman, Argentina, 4000
	Australia, New South Wales
	GenesisCare -North Shore Oncology [Recruiting] St Leonards, New South Wales, Australia, 2065
	Calvary Mater Newcastle Hospital [Recruiting] Waratah, New South Wales, Australia, 2298
	Australia, South Australia
	The Queen Elizabeth Hospital [Recruiting] Woodville South, South Australia, Australia, 5011
	Australia, Victoria
	Ballarat Health Services [Recruiting] Ballarat, Victoria, Australia, 3350
	Austin Health, Austin Hospital [Recruiting] Heidelberg, Victoria, Australia, 3084
	Austria
	Medizinische Universitaet Graz [Recruiting] Graz, Austria, 8036
	Medizinische Universitaet Innsbruck [Recruiting] Innsbruck, Austria, 6020
	Landeskrankenhaus Feldkirch [Recruiting] Rankweil, Austria, 6830
	Landeskrankenhaus Salzburg [Recruiting] Salzburg, Austria, 5020
	Universitaetsklinikum Allgemeines Krankenhaus Wien [Recruiting] Wien, Austria, 1090
	Krankenhaus Wiener Neustadt [Recruiting] Wiener Neustadt, Austria, 2700
	Belgium
	Universite Catholique de Louvain Cliniques Universitaires Saint Luc [Recruiting] Bruxelles, Belgium, 1200
	Grand Hopital de Charleroi [Recruiting] Charleroi, Belgium, 5530
	Universitair Ziekenhuis Antwerpen [Recruiting] Edegem, Belgium, 2650
	Universitair Ziekenhuis Gent [Recruiting] Gent, Belgium, 9000
	Universitair Ziekenhuis Brussel [Recruiting] Jette, Belgium, 1090
	Universitair Ziekenhuis Leuven - Campus Gasthuisberg [Recruiting] Leuven, Belgium, 3000
	Hopital De Libramont [Recruiting] Libramont, Belgium, 6800
	Centre Hospitalier Universitaire de Liege - Sart Tilman [Recruiting] Liege, Belgium, 4000
	Brazil
	Instituto Coi [Recruiting] Rio de Janeiro, Brazil, 22793-080
	Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp [Recruiting] São Paulo, Brazil, 04501-000
	Brazil, Ceará
	Hospital Haroldo Juacaba - Instituto do Cancer do Ceara [Recruiting] Fortaleza, Ceará, Brazil, 60430-230
	Brazil, Distrito Federal
	Hospital Sirio Libanes [Recruiting] Brasilia, Distrito Federal, Brazil, 70200-730
	Brazil, Minas Gerais
	Personal Oncologia de Precisao e Personalizada [Recruiting] Belo Horizonte, Minas Gerais, Brazil, 30130-090
	Brazil, Rio Grande Do Norte
	Liga Norte-Riograndense Contra O Cancer [Recruiting] Natal, Rio Grande Do Norte, Brazil, 59075-740
	Brazil, Rio Grande Do Sul
	Hospital das Clinicas de Porto Alegre [Recruiting] Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
	Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus [Recruiting] Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
	Brazil, São Paulo
	Fundacao Pio 12 Hospital de Amor de Barretos [Recruiting] Barretos, São Paulo, Brazil, 14784-400
	Instituto do Cancer Arnaldo Vieira de Carvalho [Recruiting] Sao Paulo, São Paulo, Brazil, 01221-020
	Sociedade Beneficente de Senhoras Hospital Sirio Libanes [Recruiting] Sao Paulo, São Paulo, Brazil, 01308-050
	Fundacao Antonio Prudente AC Camargo Cancer Center [Recruiting] Sao Paulo, São Paulo, Brazil, 01509-900
	Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto [Recruiting] São José do Rio Preto, São Paulo, Brazil, 15090-000
	Bulgaria
	Complex Oncology Center - Burgas [Recruiting] Burgas, Bulgaria, 8000
	Specialized Hospital for Active Treatment of Oncology - Haskovo EOOD [Recruiting] Haskovo, Bulgaria, 6300
	Multiprofile Hospital for Active Treatment - Uni Hospital OOD [Recruiting] Panagyurishte, Bulgaria, 4500
	Multiprofile Hospital for Active Treatment Central Onco Hospital OOD [Recruiting] Plovdiv, Bulgaria, 4000
	Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia [Recruiting] Sofia, Bulgaria, 1606
	Canada
	CHU de Quebec Hopital de l Enfant Jesus [Recruiting] Quebec, Canada, G1J 1Z4
	Canada, Ontario
	London Health Sciences Centre [Recruiting] London, Ontario, Canada, N6A 5W9
	Princess Margaret Cancer Centre [Recruiting] Toronto, Ontario, Canada, M4G 2C1
	Canada, Quebec
	Centre Hospitalier de L Universite de Montreal [Recruiting] Montréal, Quebec, Canada, H2X 3E4
	Chile
	IC La Serena Research [Recruiting] La Serena, Chile, 1720430
	Centro de Estudios Clinicos SAGA Spa [Recruiting] Santiago, Chile, 7500653
	Oncovida [Recruiting] Santiago, Chile, 7510032
	Icegclinic [Recruiting] Santiago, Chile, 8241479
	Centro de Estudios Clinicos e Investigaciones Medicas CeCim [Recruiting] Santiago, Chile, 8330336
	Chile, Santiago
	Centro De Estudios Clínicos Suecia SpA [Recruiting] Santiago de Chile, Santiago, Chile, 7510062
	Chile, Valparaíso
	Oncocentro Apys [Recruiting] Viña del Mar, Valparaíso, Chile, 2520598
	China, Guangdong
	Sun Yat-sen University Cancer Center [Recruiting] Guangzhou, Guangdong, China, 510030
	China, Jiangsu
	Zhongda Hospital Southeast University [Recruiting] Nanjing, Jiangsu, China, 210009
	Czechia
	Fakultni nemocnice Hradec Kralove [Recruiting] Hradec Kralove, Czechia, 500 05
	Fakultni nemocnice Olomouc [Recruiting] Olomouc, Czechia, 779 00
	Fakultni nemocnice Kralovske Vinohrady [Recruiting] Praha 10, Czechia, 100 34
	Vseobecna fakultni nemocnice v Praze [Recruiting] Praha 2, Czechia, 128 08
	Fakultni Thomayerova nemocnice [Recruiting] Praha 4, Czechia, 140 59
	France
	Centre Hospitalier Universitaire Amiens Picardie - Hopital Sud [Recruiting] Amiens Cedex 1, France, 80054
	Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz [Recruiting] Besançon, France, 25030
	Institut Bergonie [Recruiting] Bordeaux, France, 33000
	Centre Hospitalier Universitaire de Brest [Recruiting] Brest, France, 29200
	Centre Hospitalier Universitaire de Clermont Ferrand, Hôpital Estaing [Recruiting] Clermont-Ferrand cedex 1, France, 63003
	Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez [Recruiting] Lille, France, 59037
	Centre Hospitalier Universitaire de Limoges - Hopital Dupuytren [Recruiting] Limoges Cedex, France, 87042
	Centre Leon Berard [Recruiting] Lyon cedex 8, France, 69373
	Centre Antoine Lacassagne [Recruiting] Nice, France, 06189
	Hôpital Européen Georges Pompidou [Recruiting] Paris, France, 75015
	Hôpital Saint Louis [Recruiting] Paris Cedex 10, France, 75475
	Institut Mutualiste Montsouris [Recruiting] Paris Cedex 14, France, 75674
	Centre Hospitalier Universitaire de Rouen [Recruiting] Rouen Cedex, France, 76031
	Centre Rene Gauducheau - Institut de Cancerologie de l Ouest [Recruiting] Saint Herblain, France, 44800
	Centre Hospitalier Universitaire Nord de Saint Etienne - Hôpital Nord [Recruiting] Saint Priest en Jarez, France, 42270
	Institut de cancerologie Strasbourg Europe [Recruiting] Strasbourg cedex, France, 67065
	Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil [Recruiting] Toulouse Cedex 9, France, 31059
	Institut Gustave Roussy [Recruiting] Villejuif, France, 94805
	Germany
	Charite - Universitaetsmedizin Berlin, Campus Virchow [Recruiting] Berlin, Germany, 13353
	Universitaetsklinikum Dresden [Recruiting] Dresden, Germany, 01307
	Krankenhaus Nordwest GmbH [Recruiting] Frankfurt am Main, Germany, 60488
	Haematologisch Onkologische Praxis Eppendorf [Recruiting] Hamburg, Germany, 20249
	Medizinische Hochschule Hannover [Recruiting] Hannover, Germany, 30625
	Universitaetsklinikum Schleswig-Holstein [Recruiting] Kiel, Germany, 24105
	Universitaetsklinikum Leipzig [Recruiting] Leipzig, Germany, 04103
	Regional Kliniken Holding Klinikum Ludwigsburg [Recruiting] Ludwigsburg, Germany, 71640
	Johannes Gutenberg Universitaet Mainz [Recruiting] Mainz, Germany, 55131
	Universitaetsmedizin Mannheim [Recruiting] Mannheim, Germany, 68167
	Klinikum der LMU Muenchen [Recruiting] Muenchen, Germany, 81377
	Klinikum rechts der Isar der TUM [Recruiting] Muenchen, Germany, 81675
	Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen [Recruiting] Tuebingen, Germany, 72076
	Universitaetsklinikum Ulm [Recruiting] Ulm, Germany, 89081
	Klinikum der Stadt Wolfsburg [Recruiting] Wolfsburg, Germany, 38440
	Hong Kong
	Prince of Wales Hospital [Recruiting] Shatin, New Territories, Hong Kong
	Hungary
	Semmelweis Egyetem [Recruiting] Budapest, Hungary, 1082
	Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet [Recruiting] Budapest, Hungary, 1097
	Orszagos Onkologiai Intezet [Recruiting] Budapest, Hungary, 1122
	Debreceni Egyetem Klinikai Kozpont [Recruiting] Debrecen, Hungary, 4032
	Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet [Recruiting] Szolnok, Hungary, 5004
	Komarom-Esztergom Varmegyei Szent Borbala Korhaz [Recruiting] Tatabanya, Hungary, 2800
	Israel
	Rambam Health Care Campus [Recruiting] Haifa, Israel, 3109601
	Shaare Zedek Medical Center [Recruiting] Jerusalem, Israel, 9103102
	Hadassah Ein-Kerem Medical Center [Recruiting] Jerusalem, Israel, 9112001
	Sheba Medical Center [Recruiting] Ramat Gan, Israel, 5262000
	Tel-Aviv Sourasky Medical Center [Recruiting] Tel Aviv, Israel, 6423906
	Italy
	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona [Recruiting] Ancona, Italy, 60126
	Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii [Recruiting] Bergamo, Italy, 24127
	Ente Ospedaliero IRCCS Saverio De Bellis [Recruiting] Castellana Grotte, Italy, 70013
	Azienda Socio Sanitaria Territoriale di Cremona [Recruiting] Cremona, Italy, 26100
	Azienda Ospedaliera Universitaria Careggi [Recruiting] Firenze, Italy, 50134
	Ospedale Policlinico San Martino IRCCS [Recruiting] Genova, Italy, 16132
	IRCCS Ospedale San Raffaele [Recruiting] Milano, Italy, 20132
	Fondazione IRCCS Istituto Nazionale dei Tumori [Recruiting] Milano, Italy, 20133
	Azienda Ospedaliero Universitaria Luigi Vanvitelli [Recruiting] Napoli, Italy, 80131
	Istituto Oncologico Veneto IRCCS [Recruiting] Padova, Italy, 35128
	Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara [Recruiting] Pisa, Italy, 56126
	Japan, Aichi
	Nagoya University Hospital [Recruiting] Nagoya-shi, Aichi, Japan, 466-8560
	Japan, Chiba
	Chiba Cancer Center [Recruiting] Chiba-shi, Chiba, Japan, 260-8717
	National Cancer Center Hospital East [Recruiting] Kashiwa-shi, Chiba, Japan, 277-8577
	Japan, Ehime
	National Hospital Organization Shikoku Cancer Center [Recruiting] Matsuyama-shi, Ehime, Japan, 791-0280
	Japan, Fukuoka
	National Hospital Organization Kyushu Cancer Center [Recruiting] Fukuoka-shi, Fukuoka, Japan, 811-1395
	Japan, Gifu
	Gifu University Hospital [Recruiting] Gifu-shi, Gifu, Japan, 501-1194
	Japan, Hokkaido
	Hokkaido University Hospital [Recruiting] Sapporo, Hokkaido, Japan, 060-8648
	Japan, Hyogo
	Hyogo Cancer Center [Recruiting] Akashi-shi, Hyogo, Japan, 673-8558
	Kobe City Medical Center General Hospital [Recruiting] Kobe-shi, Hyogo, Japan, 650-0047
	Japan, Kanagawa
	Yokohama City University Medical Center [Recruiting] Yokohama-shi, Kanagawa, Japan, 232-0024
	Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center [Recruiting] Yokohama-shi, Kanagawa, Japan, 241-8515
	Japan, Niigata
	Niigata Cancer Center Hospital [Recruiting] Niigata-shi, Niigata, Japan, 951-8566
	Japan, Osaka
	Kansai Medical University Hospital [Recruiting] Hirakata-shi, Osaka, Japan, 573-1191
	Osaka International Cancer Institute [Recruiting] Osaka-shi, Osaka, Japan, 541-8567
	Kindai University Hospital [Recruiting] Osakasayama-shi, Osaka, Japan, 589-8511
	Osaka University Hospital [Recruiting] Suita-shi, Osaka, Japan, 565-0871
	Japan, Saitama
	Saitama Cancer Center [Recruiting] Kitaadachi-gun, Saitama, Japan, 362-0806
	Japan, Shizuoka
	Shizuoka Cancer Center [Recruiting] Sunto-gun, Shizuoka, Japan, 411-8777
	Japan, Tokyo
	National Cancer Center Hospital [Recruiting] Chuo-ku, Tokyo, Japan, 104-0045
	The Cancer Institute Hospital of Japanese Foundation for Cancer Research [Recruiting] Koto-ku, Tokyo, Japan, 135-8550
	Korea, Republic of
	Kyungpook National University Chilgok Hospital [Recruiting] Daegu, Korea, Republic of, 41404
	Chungnam National University Hospital [Recruiting] Daejeon, Korea, Republic of, 35015
	Jeonbuk National University Hospital [Recruiting] Jeonju-si, Jeollabuk-do, Korea, Republic of, 54907
	Seoul National University Bundang Hospital [Recruiting] Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
	Korea University Anam Hospital [Recruiting] Seoul, Korea, Republic of, 02841
	Seoul National University Hospital [Recruiting] Seoul, Korea, Republic of, 03080
	Kangbuk Samsung Hospital [Recruiting] Seoul, Korea, Republic of, 03181
	Severance Hospital Yonsei University Health System [Recruiting] Seoul, Korea, Republic of, 03722
	Asan Medical Center [Recruiting] Seoul, Korea, Republic of, 05505
	Samsung Medical Center [Recruiting] Seoul, Korea, Republic of, 06351
	The Catholic University of Korea Seoul St Marys Hospital [Recruiting] Seoul, Korea, Republic of, 06591
	Korea University Guro Hospital [Recruiting] Seoul, Korea, Republic of, 08308
	Poland
	Narodowy Instytut Onkologii im M Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwicach [Recruiting] Gliwice, Poland, 44-102
	Przychodnia Lekarska Komed Roman Karaszewski [Recruiting] Konin, Poland, 62-500
	Samodzielny Publiczny Szpital Kliniczny Nr 1 [Recruiting] Lublin, Poland, 20-080
	Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo [Recruiting] Siedlce, Poland, 08-110
	Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie [Recruiting] Szczecin, Poland, 71-252
	Lux med onkologia sp zoo szpital szamocka [Recruiting] Warszawa, Poland, 01-748
	Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu [Terminated] Wroclaw, Poland, 50-556
	Portugal
	Hospital de Braga, EPE [Recruiting] Braga, Portugal, 4710-243
	Hospital da Senhora da Oliveira Guimaraes, EPE [Recruiting] Guimaraes, Portugal, 4835-044
	Hospital da Luz, SA [Recruiting] Lisboa, Portugal, 1500-650
	Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria [Recruiting] Lisboa, Portugal, 1649-035
	Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano [Recruiting] Matosinhos, Portugal, 4464-513
	Hospital Cuf porto [Recruiting] Porto, Portugal, 4100-180
	Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao [Recruiting] Porto, Portugal, 4200-319
	Romania
	Institutul Clinic Fundeni [Recruiting] Bucharest, Romania, 022328
	Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca [Recruiting] Cluj Napoca, Romania, 400015
	Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor [Recruiting] Cluj-Napoca, Romania, 400000
	Centrul de Oncologie Sf Nectarie SRL [Recruiting] Craiova, Romania, 200542
	Institutul Regional de Oncologie Iasi [Recruiting] Iasi, Romania, 700483
	SC Oncomed SRL [Recruiting] Timisoara, Romania, 300239
	Singapore
	National University Hospital [Recruiting] Singapore, Singapore, 119074
	National Cancer Centre Singapore [Recruiting] Singapore, Singapore, 168583
	Spain
	Hospital Universitario Ramon y Cajal [Recruiting] Madrid, Spain, 28034
	Hospital Clinico San Carlos [Recruiting] Madrid, Spain, 28040
	Hospital Universitario 12 de Octubre [Recruiting] Madrid, Spain, 28041
	Spain, Andalucía
	Hospital Universitario Virgen del Rocio [Recruiting] Sevilla, Andalucía, Spain, 41013
	Spain, Asturias
	Hospital Universitario Central de Asturias [Recruiting] Oviedo, Asturias, Spain, 33011
	Spain, Cantabria
	Hospital Universitario Marques de Valdecilla [Recruiting] Santander, Cantabria, Spain, 39008
	Spain, Cataluña
	Hospital del Mar [Recruiting] Barcelona, Cataluña, Spain, 08003
	Hospital Universitari Vall d Hebron [Recruiting] Barcelona, Cataluña, Spain, 08035
	Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals [Recruiting] Hospitalet de Llobregat, Cataluña, Spain, 08908
	Spain, Comunidad Valenciana
	Hospital General Universitario de Elche [Recruiting] Elche, Comunidad Valenciana, Spain, 03203
	Hospital Clinico Universitario de Valencia [Recruiting] Valencia, Comunidad Valenciana, Spain, 46010
	Spain, Galicia
	Complexo Hospitalario Universitario A Coruña Hospital Teresa Herrera [Recruiting] A Coruña, Galicia, Spain, 15006
	Spain, Navarra
	Hospital Universitario de Navarra [Recruiting] Pamplona, Navarra, Spain, 31008
	Switzerland
	Universitaetsspital Basel [Recruiting] Basel, Switzerland, 4031
	Hopitaux Universitaires de Geneve [Recruiting] Geneve, Switzerland, 1205
	Taiwan
	Kaohsiung Medical University Chung-Ho Memorial Hospital [Recruiting] Kaohsiung, Taiwan, 80756
	China Medical University Hospital [Recruiting] Taichung, Taiwan, 40447
	National Cheng Kung University Hospital [Recruiting] Tainan, Taiwan, 70403
	Taipei Veterans General Hospital [Recruiting] Taipei, Taiwan, 11217
	Tri-Service General Hospital [Recruiting] Taipei, Taiwan, 11490
	Thailand
	Chulabhorn Hospital [Recruiting] Bangkok, Thailand, 10210
	Maharaj Nakorn Chiang Mai Hospital [Recruiting] Chiang Mai, Thailand, 50200
	Chiangrai Prachanukroh Hospital [Recruiting] Chiang Rai, Thailand, 57000
	Prince of Songkla Hospital [Recruiting] Songkhla, Thailand, 90110
	United Kingdom
	Addenbrookes Hospital [Recruiting] Cambridge, United Kingdom, CB2 0QQ
	University Hospital Coventry [Recruiting] Coventry, United Kingdom, CV2 2DX
	Ninewells Hospital and Medical School [Recruiting] Dundee, United Kingdom, DD1 9SY
	Guys Hospital [Recruiting] London, United Kingdom, SE1 9RT
	Christie Hospital [Recruiting] Manchester, United Kingdom, M20 4BX
	Mount Vernon Cancer Centre [Recruiting] Northwood, United Kingdom, HA6 2RN
	Torbay Hospital [Recruiting] Torquay, United Kingdom, TQ2 7AA

IPDSharing


Plan to Share IPD:	Yes De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
	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.
	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.
	URL: http://www.amgen.com/datasharing

References


Citations:
Links:	URL: http://www.amgentrials.com Description: AmgenTrials clinical trials website
Available IPD/Information: