Testing Ivonescimab in Combination With Chemotherapy in Advanced or Metastatic Gastric/Gastroesophageal Adenocarcinoma
Phase II Study Evaluating Ivonescimab in Combination With Chemotherapy for First- and Second-line Treatment of Advanced or Metastatic Gastric and Gastroesophageal Adenocarcinoma Patients
Sponsor: UNICANCER + Summit Therapeutics
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate assessed by central review
Time frame: Time from inclusion to disease progression, up to 3 years
Secondary Endpoints
Objective Response Rate assessed by the investigator
Duration of response
Progression-free survival (PFS)
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Histologically or cytologically proven gastric cancer (GC) or esophagogastric junction cancer adenocarcinoma (EGJC) 3. Metastatic or locally advanced non resectable (stage IV) disease. 4. Presence of at least one measurable lesion as assessed by the investigator according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Age ≥18 years. 7. For patients without actionable biomarker (HER2 and Claudin 18.2-negative) except for PD-L1, no prior treatment for advanced disease (cohort 1). For patients with at least one of the following actionable biomarker (PD-L1 CPS≥1, and/or HER2-positive, and/or Claudin 18.2-positive), who had received only one…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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