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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLOT plus Bemarituzumab | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bemarituzumab | Drug | • Bemarituzumab will be given as a IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2.3 years from first patient in |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3.6 years from first patients in |
| Pathological complete response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| EORTC EORTC | Contact | +32 27741611 | eortc@eortc.org |
| Name | Affiliation | Role |
|---|---|---|
| Markus Moehler | University Medical Center Mainz | Principal Investigator |
| Elizabeth Smyth | University of Oxford | Principal Investigator |
| Maike Collienne |
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| ID | Term |
|---|---|
| C000714767 | bemarituzumab |
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| FLOT |
| Drug |
FLOT will be given as a IV infusion |
|
| 3.6 years from first patients in |
| Progression free survival (PFS) | Progression-free survival is defined as the time interval from enrolment to the first event of progression/recurrence | 3.6 years from first patients in |
| Overall survival (OS) | Overall survival will be computed from the date of enrolment to the date of death | 3.6 years from first patients in |
| Treatment-emergent adverse events | 3.6 years from first patients in |
| R0 resection | 3.6 years from first patients in |
| Completion rate of neoadjuvant and adjuvant therapy | 3.6 years from first patients in |
| Postoperative complications according to CLAVIEN DINDO classification | 3.6 years from first patients in |
| 30 and 90 day-mortality after surgery | 1.7 years from first patients in |
| University Medical Center Mannheim |
| Principal Investigator |