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MOONLIGHT: Nivolumab and Ipilimumab with Chemotherapy in Gastric Cancer
NCT03647969Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2018
- Primary completion
- Jul 2024
- Countries
- 1
- Modality
- Monoclonal Antibodies
- Drugs
- nivolumabipilimumab
- Conditions
- Adenocarcinoma of the stomach (GC)gastroesophageal junction adenocarcinoma
01
Overview
Phase 2, randomised, open-label trial of nivolumab and ipilimumab in Adenocarcinoma of the stomach (GC) and gastroesophageal junction adenocarcinoma (4 arms), sponsored by Institut für Klinische Krebsforschung. Primary endpoints: Progression-free survival at 3 years and Progression-free Survival rate at 6 months. Started Nov 2018; status: completed.
02
Design
4 arms- Study design
- RandomizedOpen-label
mFOLFOX + Nivo + Ipi
Concurrent mFOLFOX with Nivolumab and Ipilimumab
Sequential mFOLFOX -> Nivo + Ipi
Induction mFOLFOX followed by Nivolumab and Ipilimumab
mFOLFOX
Standard mFOLFOX chemotherapy
FLOT + Nivo
FLOT chemotherapy with Nivolumab
03
Who it enrols
Patients with inoperable, advanced or metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction who have not received prior systemic treatment for advanced disease. Patients must have ECOG PS 0-1 and adequate organ function. Exclusion criteria include active autoimmune disease, symptomatic CNS metastases, and prior checkpoint inhibitor therapy.
04
Endpoints
Primary
Progression-free survival
Progression-free Survival rate at 6 months
Secondary
Progression-free survival
Progression-free Survival rate at 6 months
Overall Response Rate
Duration of response and disease stabilization
Overall survival
Incidence and severity of adverse events
Quality of life
Progression-free survival by PD-L1 expression status
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