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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05111626




Registration number
NCT05111626
Ethics application status
Date submitted
29/10/2021
Date registered
8/11/2021

Titles & IDs
Public title
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
Scientific 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 ID [1] 0 0
2023-505458-16
Secondary ID [2] 0 0
20210098
Universal Trial Number (UTN)
Trial acronym
FORTITUDE-102
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Gastroesophageal Junction Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Bemarituzumab
Treatment: Drugs - Nivolumab
Treatment: Drugs - Chemotherapy
Other interventions - Placebo

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).

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.

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.


Treatment: Drugs: Bemarituzumab
Bemarituzumab will be administered as intravenous (IV) infusion.

Treatment: Drugs: Nivolumab
Nivolumab will be administered as IV infusion.

Treatment: Drugs: 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.

Other interventions: Placebo
Placebo will be administered as IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants Who Experienced DLTs
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to 4.5 years
Primary outcome [3] 0 0
Part 1: Number of Participants Who Experienced One or More Related TEAEs
Timepoint [3] 0 0
Up to 4.5 years
Primary outcome [4] 0 0
Part 1: Number of Participants With Clinically Significant Changes in Vital Signs
Timepoint [4] 0 0
Up to 4.5 years
Primary outcome [5] 0 0
Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity
Timepoint [5] 0 0
Up to 4.5 years
Primary outcome [6] 0 0
Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations
Timepoint [6] 0 0
Up to 4.5 years
Primary outcome [7] 0 0
Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Timepoint [7] 0 0
Up to 4.5 years
Primary outcome [8] 0 0
Part 2: Overall Survival in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants
Timepoint [8] 0 0
Up to 4.5 years
Secondary outcome [1] 0 0
Part 1: Objective Response (OR)
Timepoint [1] 0 0
Up to 4.5 years
Secondary outcome [2] 0 0
Part 1: Duration of Response (DoR)
Timepoint [2] 0 0
Up to 4.5 years
Secondary outcome [3] 0 0
Part 1: Disease Control Rate (DCR)
Timepoint [3] 0 0
Up to 4.5 years
Secondary outcome [4] 0 0
Part 1: Progression Free Survival (PFS)
Timepoint [4] 0 0
Up to 4.5 years
Secondary outcome [5] 0 0
Part 1: Overall Survival
Timepoint [5] 0 0
Up to 4.5 years
Secondary outcome [6] 0 0
Part 1: Maximum Observed Concentration (Cmax) of Bemarituzumab
Timepoint [6] 0 0
Day 1 to up to 4.5 years
Secondary outcome [7] 0 0
Part 1: Area Under the Concentration Time Curve (AUC) of Bemarituzumab
Timepoint [7] 0 0
Day 1 to up to 4.5 years
Secondary outcome [8] 0 0
Part 1: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab
Timepoint [8] 0 0
Day 1 to up to 4.5 years
Secondary outcome [9] 0 0
Part 1: Number of Participants With Anti-Bemarituzumab Antibody Formation
Timepoint [9] 0 0
Day 1 to up to 4.5 years
Secondary outcome [10] 0 0
Part 2: PFS in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants
Timepoint [10] 0 0
Up to 4.5 years
Secondary outcome [11] 0 0
Part 2: OR in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants
Timepoint [11] 0 0
Up to 4.5 years
Secondary outcome [12] 0 0
Part 2: Number of Participants Who Experienced One or More TEAEs
Timepoint [12] 0 0
Up to 4.5 years
Secondary outcome [13] 0 0
Part 2: Number of Participants With Clinically Significant Changes in Vital Signs
Timepoint [13] 0 0
Up to 4.5 years
Secondary outcome [14] 0 0
Part 2: Number of Participants With Clinically Significant Changes in Visual Acuity
Timepoint [14] 0 0
Up to 4.5 years
Secondary outcome [15] 0 0
Part 2: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Timepoint [15] 0 0
Up to 4.5 years
Secondary outcome [16] 0 0
Part 2: Overall Survival in All Randomized Participants
Timepoint [16] 0 0
Up to 4.5 years
Secondary outcome [17] 0 0
Part 2: PFS in All Randomized Participants
Timepoint [17] 0 0
Up to 4.5 years
Secondary outcome [18] 0 0
Part 2: Objective Response Rate (ORR) in All Randomized Participants
Timepoint [18] 0 0
Up to 4.5 years
Secondary outcome [19] 0 0
Part 2: DoR in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants
Timepoint [19] 0 0
Up to 4.5 years
Secondary outcome [20] 0 0
Part 2: DCR in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants
Timepoint [20] 0 0
Up to 4.5 years
Secondary outcome [21] 0 0
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
Timepoint [21] 0 0
Up to 4.5 years
Secondary outcome [22] 0 0
Part 2: Change From Baseline in EORTC QLQ-C30 Individual Scores in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants
Timepoint [22] 0 0
Baseline to up to 4.5 years
Secondary outcome [23] 0 0
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
Timepoint [23] 0 0
Up to 4.5 years
Secondary outcome [24] 0 0
Part 2: Change From Baseline in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants
Timepoint [24] 0 0
Baseline to up to 4.5 years
Secondary outcome [25] 0 0
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
Timepoint [25] 0 0
Up to 4.5 years
Secondary outcome [26] 0 0
Part 2: Change From Baseline of VAS Scores as Measured by EQ-5D-5L in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants
Timepoint [26] 0 0
Baseline to up to 4.5 years
Secondary outcome [27] 0 0
Part 2: Time to Deterioration in Stomach Cancer Related Symptoms Measured by EORTC QLQ-STO22 in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants
Timepoint [27] 0 0
Day 1 to up to 4.5 years
Secondary outcome [28] 0 0
Part 2: Time to Deterioration in Health-Related Quality of Life (HRQoL) Scores in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants
Timepoint [28] 0 0
Day 1 to up to 4.5 years
Secondary outcome [29] 0 0
Part 2: Time to Deterioration in Physical Function Scores in FGFR2b = 10% 2+/3+ Tumor Cell Staining Participants
Timepoint [29] 0 0
Day 1 to up to 4.5 years
Secondary outcome [30] 0 0
Part 2: Cmax of Bemarituzumab
Timepoint [30] 0 0
Day 1 to up to 4.5 years
Secondary outcome [31] 0 0
Part 2: Ctrough of Bemarituzumab
Timepoint [31] 0 0
Day 1 to up to 4.5 years
Secondary outcome [32] 0 0
Part 2: Number of Participants With Anti-Bemarituzumab Antibody Formation
Timepoint [32] 0 0
Day 1 to up to 4.5 years

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/09/2026
Actual
Sample size
Target
528
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
GenesisCare -North Shore Oncology - St Leonards
Recruitment hospital [2] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [4] 0 0
Ballarat Health Services - Ballarat
Recruitment hospital [5] 0 0
Austin Health, Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3350 - Ballarat
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
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United States of America
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Florida
Country [5] 0 0
United States of America
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Illinois
Country [6] 0 0
United States of America
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Maryland
Country [7] 0 0
United States of America
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Michigan
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United States of America
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Minnesota
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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Oregon
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United States of America
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Distrito Federal
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Argentina
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Jujuy
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Argentina
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Río Negro
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Argentina
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Santa Fe
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Argentina
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Tucuman
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Argentina
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Capital Federal
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Argentina
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Córdoba
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Argentina
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La Rioja
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Rankweil
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Austria
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Salzburg
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Austria
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Wiener Neustadt
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Austria
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Wien
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Belgium
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Brussels
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Belgium
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Bruxelles
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Charleroi
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Jette
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Leuven
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Libramont
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Liege
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Turnhout
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Ceará
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Distrito Federal
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Espírito Santo
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Rio Grande Do Norte
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Rio Grande Do Sul
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São Paulo
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Rio de Janeiro
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Bulgaria
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Burgas
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Haskovo
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Bulgaria
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Panagyurishte
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Bulgaria
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Plovdiv
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Sofia
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Ontario
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Quebec
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Santiago
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Valparaíso
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Chile
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La Serena
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Anhui
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Beijing
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Chongqing
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Fujian
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Gansu
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Guangdong
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Guangxi
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Hainan
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Hebei
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Jiangsu
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Jiangxi
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Jilin
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Ningxia
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Tianjin
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Yunnan
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Zhejiang
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Colombia
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Antioquia
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Colombia
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Cesar
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Santander
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Czechia
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Hradec Kralove
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Praha 2
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Czechia
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Praha 4
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Amiens Cedex 1
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Besançon
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Clermont-Ferrand cedex 1
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Lille
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Limoges Cedex
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France
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Lyon cedex 8
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France
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Nice
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France
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Paris Cedex 10
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France
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Paris Cedex 14
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France
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Paris
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France
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Rennes Cedex 9
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France
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Rouen Cedex
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France
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Saint Herblain
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France
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Saint Priest en Jarez
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Strasbourg cedex
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France
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Toulouse Cedex 9
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France
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Villejuif
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Frankfurt am Main
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Kiel
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Germany
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Leipzig
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Germany
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Ludwigsburg
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Muenchen
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Germany
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Tuebingen
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Germany
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Ulm
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Germany
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Wolfsburg
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Hong Kong
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Shatin, New Territories
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Hungary
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Budapest
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Hungary
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Debrecen
Country [134] 0 0
Hungary
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Nyiregyhaza
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Hungary
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Szekszard
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Hungary
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Szolnok
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Hungary
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Tatabanya
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Italy
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Torquay

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05111626