This is an open-label,multi-centre, phase 1b safety and feasibility study aiming to assess the safey and feasibility of bemarituzumab plus chemiotherapy (FLOT) for the peri-operative treatment of resectable gastroesophageal cancer. Following this neo-adjuvant part, patients should undergo surgery. Following surgery, patients will receive FLOT chemotherapy in combination with bemarituzumab. Imaging will be performed every 3 months for the first 2 years and thereafter every 6 months as per standard of care.
Signed screening informed consent
Age ≥ 18 years
Availability of a diagnostic tumour sample for central evaluation (FFPE block or minimum 10 slides).
Histologically proven, previously untreated, locally advanced, resectable gastric/GEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0. Note: if the results of the staging laparoscopy are pending at this stage it is acceptable to include the patients in this step, in the interest of patient time-to-treatment.
Prior anticancer treatment for the disease under investigation
History or evidence of systemic disease or ophthalmological disorders requiring chronic use of ophthalmologic corticosteroids
Evidence of any ongoing ophthalmologic abnormalities or symptoms that are recent (within 4weeks) or actively progressing
Unwillingness to avoid the use of contact lenses during study treatment and follow-up period of at least 100 days after end of treatment.
Single group
Bemarituzumab
Drug• Bemarituzumab will be given as a IV infusion
FLOT
DrugFLOT will be given as a IV infusion
Completion rate of neoadjuvant treatment followed by surgery without serious anastomotic leakage, defined as the percentage of patients who completed the treatment without grade 2 or more anastomotic leakage as per Clavien-Dindo Classification
Patients will be considered to have successfully completed the neo-adjuvant treatment if they complete the 4 cycles of FLOT plus Bemarituzumab. Additionally, anastomotic leakage will be reported as post-surgery complication following the modified Clavien-Dindo Classification
Major pathological response
Major pathological response rate will be computed as the percentage of patients who had major tumour regression (\< 10% vital residual tumour cells) after neoadjuvant treatment.
Pathological complete response
Progression free survival (PFS)
Progression-free survival is defined as the time interval from enrolment to the first event of progression/recurrence
Overall survival (OS)
Overall survival will be computed from the date of enrolment to the date of death
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
