The goal of this clinical trial is to evaluate the addition of ivonescimab to standard chemotherapy in patients with advanced or metastatic gastric and gastroesophageal adenocarcinoma. The main question it aims to answer is : Does the addition of ivonescimab increase the response to treatment ? Participants will visit the clinic every 2 weeks for checkups, treatment administration and tests for collection of adverse events.
Signed a written informed consent form prior to any trial specific procedures. Note: If the patient is physically unable to provide their written consent, a trusted person of their choice, independent of the Investigator or the Sponsor, can confirm the patients consent in writing.
Histologically or cytologically proven gastric cancer (GC) or esophagogastric junction cancer adenocarcinoma (EGJC)
Metastatic or locally advanced non resectable (stage IV) disease.
Presence of at least one measurable lesion as assessed by the investigator according to RECIST v1.1.
Previous or concurrent cancer that is distinct in primary site or histology from gastroesophageal cancer within 2 years prior to study inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)].
Patients with high microsatellite instability (MSI-H) or mismatched repair disease (dMMR) tumor.
Enteral intake < 1500 kcal /d and or a weight loss > 15% of total body weight within the 6 months
Toxicities from previous treatment not resolved to grade ≤ 1 (according to the version 5.0 of the National Cancer Institute - Common terminology criteria for adverse events [NCI-CTCAE v5.0]) before treatment start with the exception of alopecia.
Single group
Ivonescimab
DrugIvonescimab 20 mg/kg by intravenous (IV) infusion once every 2 weeks until disease progression.
FOLFOX regimen
DrugOxaliplatin 85 mg/m2 IV, folinic acid 400 mg/m2 IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m2 as a 46 hour continuous IV infusion, every two weeks for 8 cycles followed by 5FU as maintenance therapy until disease progression.
Irinotecan
Drug180 mg/ m2 IV over 90 min infusion every two weeks for a minimum of 4 cycles
Paclitaxel
Drug80 mg/m2 IV at D1, D8 and D15, every four weeks (D1=D28)
Objective Response Rate assessed by central review
The objective response rate is defined as the percentage of patients with a complete response (CR) or a partial response (PR) for a given treatment
Objective Response Rate assessed by the investigator
The objective response rate is defined as the percentage of patients with a complete response (CR) or a partial response (PR) for a given treatment
Duration of response
The time form first documented response (compared to baseline measurement taken at inclusion) until the date of disease progression or death from any cause, whichever occurs first
Progression-free survival (PFS)
The progression-free survival is the lengh of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse
Overall Survival (OS)
The overall survival is the length of time from inclusion that patients enrolled in the study are still alive.
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UNICANCER
Lead sponsor
Summit Therapeutics
Collaborator
