The goal of this clinical trial is to evaluate if bemarituzumab in combination with different standard of care chemotherapies enhance tumor response in patients with FGFR2b-positive advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. The main questions are: How do patients respond to these treatments? How is the overall and the progression-free survival rate with these treatments? How is the disease control rate with these treatments? How long is the duration of response and disease stabilization with these treatments? How is the safety with these treatments? How is the quality of life with these treatments? Patients will be allocated to one of three possible treatment cohorts according to investigator's decision and current standard of care: Bemarituzumab with cohort 1: irinotecan cohort 2: paclitaxel plus ramucirumab cohort 3: trifluridine/tipiracil
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Cohort 2 will receive bemarituzumab plus SOC treatment with paclitaxel and ramucirumab
Cohort 1 will receive bemarituzumab plus SOC treatment with irinotecan
Cohort 3 will receive bemarituzumab plus SOC treatment with trifluridine/tipiracil
Uniklinik RWTH Aachen
Aachen, Germany
Klinikum St. Marien
Amberg, Germany
Universitätsklinikum Augsburg
Augsburg, Germany
Helios Klinikum Bad Saarow
Bad Saarow, Germany
Klinikum Neukölln Vivantes Netzwerk für Gesundheit GmbH Klinlinik für Innere Medizin - Hämatologie und Onkologie
Berlin, Germany
Objective response rate (ORR)
Objective response rate (ORR), defined as proportion of subjects with a complete response (CR) or partial response (PR) acc. to RECIST v1.1, for each cohort (cohort 1 - bemarituzumab plus irinotecan, cohort 2 - bemarituzumab plus paclitaxel and ramucirumab, cohort 3 - bemarituzumab plus trifluridine/tipiracil).
Time frame: from date of enrollment to date of last response acc. to RECIST v1.1 or death due to any cause, through study completion, up to 33 months
Progression-free survival (PFS)
Progression-free survival (PFS)
Time frame: from date of enrollment to date of progression acc. to RECIST v1.1 or death due to any cause, through study completion, up to 33 months
Overall survival (OS)
Overall survival (OS)
Time frame: time from date of enrollment to date of death due to any cause, through study completion, up to 33 months
Disease control rate (DCR)
proportion of subjects with CR, PR or stable disease (SD) according to RECIST v1.1
Time frame: time from date of enrollment to date of last tumor assessment acc. to RECIST 1.1 or death due to any cause, through study completion, up to 33 months
Duration of response (DoR)
Duration of response (DoR)
Time frame: time from response initiation (when either CR or PR is first determined) to date of progression or death to any cause, through study completion, up to 33 months
Disease stabilization
Duration of disease stabilization
Time frame: time from the first assessment of CR or PR or SD until the date of progression or death to any cause, through study completion, up to 33 months
Quality of Life (QoL) with EORTC QLQ C30
Assessment of quality of life using EORTC QLQ C30 questionnaires during treatment
Time frame: time from baseline questionnaire to last filled questionnaire in follow up or until progression or death of any cause, through study completion, up to 33 months
Quality of Life (QoL) with EQ-5D-5L
Assessment of quality of life using EQ-5D-5L visual analogue scale (VAS) score
Time frame: time from baseline questionnaire to last filled questionnaire in follow up or until progression or death of any cause, through study completion, up to 33 months
Quality of Life (QoL) with HADS
Assessment anxiety/depression and satisfaction using HADS during treatment
Time frame: time from baseline questionnaire to last filled questionnaire in follow up or until progression or death of any cause, through study completion, up to 33 months
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Charité - Universitätsmedizin Berlin Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CVK)
Berlin, Germany
VIVANTES Berlin Friedrichshain
Berlin, Germany
Klinikum Bielefeld gem. GmbH Klinik für Hämatologie, Onkologie und Palliativmedizin
Bielefeld, Germany
Klinikum Chemnitz
Chemnitz, Germany
St.-Johannes-Hospital
Dortmund, Germany
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