Clinical trial NCT06978062: Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment
Official title: An Open-label, Multi-centre, Phase 1b Safety and Feasibility Study for the Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment (NeoBEMA)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: GastroEsophageal Cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2025-05-18
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.
* Planned peri-operative treatment with FLOT chemotherapy and surgically assessed feasible R0 resection
* Centrally confirmed FGFR2b overexpression as defined by ≥10% tumour cells with 2+/3+ FGFR2b staining by immunohistochemistry (IHC)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Previously untreated, locally advanced, histologically confirmed, resectable gastric/GEJ adenocarcinoma cT2-cT4, N0, M0 or cTany, N+, M0 by radiological and surgical staging
* Adequate hematologic and organ function

Exclusion Criteria:

* 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.
* Evidence of, or recent (within 6 months) history of, corneal defects, corneal ulcerations, keratitis, or keratoconus, history of corneal transplant, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer. Recent (within 6 months) corneal surgery or ophthalmologic laser treatment
* History of solid organ transplantation
* History of interstitial lung disease
* 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
* Patients on immunosuppressive therapy or having immune system disorders, including auto-immune diseases. Concurrent steroid use of not more than an equivalent of 10 mg/day prednisolone is allowed. Inhaled, intranasal, intraocular, and/or joint injections of corticosteroids are allowed.

Primary outcomes:
measure: 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
timeFrame: 2.3 years from first patient in
Secondary outcomes:
measure: Major pathological response
timeFrame: 3.6 years from first patients in
measure: Pathological complete response
timeFrame: 3.6 years from first patients in
measure: Progression free survival (PFS)
timeFrame: 3.6 years from first patients in
measure: Overall survival (OS)
timeFrame: 3.6 years from first patients in
measure: Treatment-emergent adverse events
timeFrame: 3.6 years from first patients in
measure: R0 resection
timeFrame: 3.6 years from first patients in
measure: Completion rate of neoadjuvant and adjuvant therapy
timeFrame: 3.6 years from first patients in
measure: Postoperative complications according to CLAVIEN DINDO classification
timeFrame: 3.6 years from first patients in
measure: 30 and 90 day-mortality after surgery
timeFrame: 1.7 years from first patients in
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Center Mainz
name: Markus Moehler
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Elizabeth Smyth
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Mannheim
name: Maike Collienne
role: PRINCIPAL_INVESTIGATOR
References: