Peri-operative Treatment of Resectable Gastroesophageal Cancer Using Bemarituzumab (BEMA) Plus Perioperative Treatment (NeoBEMA)

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Begins enrollment in 6 months; Phase 1

Conditions: GastroEsophageal Cancer

Treatments: Drug: FLOT; Drug: Bemarituzumab

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06978062

EORTC 2385-GITCG

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

FLOT plus Bemarituzumab

Experimental group

Description:

* FLOT will be administered every 2 weeks (Q2W). Docetaxel 50 mg/m2 is given as 1 hour infusion, followed by Oxaliplatin 85mg/m2 as a 2-hour infusion, leucovorin 200 mg/m2 over 2 hours and 5-FU 2600 mg/m2 as a 24 hour-infusion, * Bemarituzumab will be administered as IV infusion

Treatment:

Drug: Bemarituzumab

Drug: FLOT