Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)
Condition(s) studied
Investigational drug(s) / intervention(s)
Givastomig: Givastomig 8mg/kg Q2W IV or 12mg/kg Q3W IV
Nivolumab: Q2 or Q3W IV
5Fluorouracil: Q2W IV
Leucovorin: Q2W IV
Oxaliplatin: Q2W or Q3W IV
Capecitabine: Twice daily x 14 days every 3 weeks PO
Study summary
The goal of this clinical trial is to learn if givastomig in combination with standard therapy works to treat adults with cancer in the stomach and/or esophagus (GEA adenocarcinoma). It will also help the researchers to learn more about the safety of givastomig. The main questions it aims to answer are:
* Does the addition of givastomig to standard therapy increase the amount of time that participants survive without progression of their cancer?
* What toxicities do participants experience when taking givastomig?
Participants may be able to take part in the study if they have unresectable or metastatic GEA and if their cancer cells express certain proteins called Claudin 18.2 (CLDN18.2) and PD-L1. Participants whose cancer cells express a protein called HER2 cannot take part.
Up to 180 participants will be randomly assigned to received givastomig at one of two doses in combination with an immunotherapy medicine called nivolumab and chemotherapy OR to receive nivolumab and chemotherapy alone. These therapies will be given primarily via intravenous (into a vein) infusion every 2 or 3 weeks.
Participants will:
* Visit the study treatment center for infusions and/or check-ups and tests every 1-3 weeks
* Report any changes in their symptoms to their study doctors
* Have scans to check for any changes in their cancer every 8-12 weeks
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS), BICR-assessed — Up to 5 years
Compare PFS between participants receiving givastomig plus nivolumab and chemotherapy versus control (nivolumab plus chemotherapy) - Safety and Tolerability — Throughout treatment and up to 30 days after last dose
Incidence, severity, and type of adverse events, including treatment-emergent and immune-related adverse events, graded by NCI CTCAE v5.0
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| I-Mab Site 1016 | Goodyear | Arizona | Recruiting |
| I-MAB Site 1005 | Duarte | California | Recruiting |
| I-Mab Site 1002 | Boston | Massachusetts | Recruiting |
| I-Mab Site 2001 | Beijing | China | Recruiting |
| I-Mab Site - 4001 | Kashiwa | Japan | Not Yet Recruiting |
| I-Mab Site 4005 | Tokyo | Japan | Recruiting |
On this site
📄 Opdivo (nivolumab) drug profile →Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07432295 on ClinicalTrials.gov ↗ ← All trials in Egypt