OncoMatch/Clinical Trials/NCT06253611
First-line EXL01 With Nivolumab and FOLFOX for PD-L1 CPS ≥5 Metastatic Gastric Cancer
Is NCT06253611 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including EXL01 and Nivolumab for gastric cancer.
Treatment: Nivolumab · FOLFOX regimen · EXL01 — This is a randomized non-comparative, multicenter phase II study in patients with PD-L1 PD-L1 combined positive score (CPS) ≥5 advanced gastric cancer to evaluate the efficacy and safety of nivolumab and FOLFOX in combination with EXL01 as first-line treatment. After signing the informed consent form, and upon confirmation of the patient's eligibility, patients will be randomized in a 2:1 ratio to either the nivolumab and FOLFOX plus EXL01 arm (experimental) or the nivolumab and FOLFOX arm (control). In both arms, treatment will be given until PD, unacceptable toxicity or for a maximum of 24 months (52 cycles).
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Biomarker criteria
Required: PD-L1 (CD274) combined positive score (CPS) ≥5 (CPS ≥5)
Expression of PD-L1 with a combined positive score (PD-L1 CPS) ≥5
Required: HER2 (ERBB2) overexpression (negative)
Known HER-2 positive status or unknown HER-2 status before inclusion [excluded]
Excluded: DPYD dihydropyrimidine dehydrogenase deficiency
Dihydropyrimidine dehydrogenase deficiency (DPD; uracilemia dosage >16 ng/ml), Uracilemia dosing results must be available before inclusion
Disease stage
Metastatic disease required
Inoperable, advanced, or metastatic gastric cancer or gastroesophageal junction or distal esophageal carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic cancer treatment
Exception: neoadjuvant/adjuvant therapy completed at least 6 months prior to diagnosis of metastatic or recurrent disease is allowed; palliative radiotherapy allowed if completed 2 weeks prior to randomization
No prior systemic cancer treatment given as primary therapy for advanced nonresectable or metastatic disease
Cannot have received: anti-PD-1 therapy
Prior treatment with an anti-PD(L)1, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
Cannot have received: anti-PD-L1 therapy
Prior treatment with an anti-PD(L)1, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
Cannot have received: anti-LAG-3 therapy
Prior treatment with an anti-PD(L)1, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
Cannot have received: anti-CTLA-4 therapy
Prior treatment with an anti-PD(L)1, anti-LAG-3, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
Cannot have received: immuno-stimulatory antitumor agent
prior therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
Lab requirements
Blood counts
White blood cell ≥ 2000/μL; Neutrophils ≥ 2000/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 9.0 g/dL; Serum albumin ≥ 30 g/L
Kidney function
Serum creatinine level ≤ 150 μM and calculated creatinine clearance (Cockcroft-Gault) > 50 mL/minute
Liver function
Total bilirubin ≤ 1.5 x ULN; ALT ≤ 3.0 x ULN (or ≤ 5.0 x ULN if liver metastases are present); AST ≤ 3.0 x ULN (or ≤ 5.0 x ULN if liver metastases are present)
Cardiac function
Baseline-corrected QT interval ≤ 450 msec for males and ≤ 470 msec for females
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to randomization of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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