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Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma

NCT06846346 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-04-28

No results posted yet for this study

Summary

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.

Conditions

  • Metastatic Esophageal Adenocarcinoma
  • Advanced Esophageal Adenocarcinoma
  • Metastatic Gastric Adenocarcinoma
  • Advanced Gastric Adenocarcinoma

Interventions

DRUG

Ivonescimab

Ivonescimab 20 mg/kg by intravenous (IV) infusion once every 2 weeks until disease progression.

DRUG

FOLFOX regimen

Oxaliplatin 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.

DRUG

Irinotecan

180 mg/ m2 IV over 90 min infusion every two weeks for a minimum of 4 cycles

DRUG

Paclitaxel

80 mg/m2 IV at D1, D8 and D15, every four weeks (D1=D28)

Sponsors & Collaborators

  • Summit Therapeutics

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Christelle DE LA FOUCHARDIERE · Institut Paoli-Calmettes

  • Judith RAIMBOURG · ICO - Site Renée Gauducheau

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2027-09-30
Completion
2028-09-30

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06846346 on ClinicalTrials.gov