OncoMatch/Clinical Trials/NCT06733038
FOLFOXIRI Plus Bevacizumab With or Without Atezolizumab as 1st Line Treatment of pMMR and IS IC-High Metastatic Colorectal Cancer Patients.
Is NCT06733038 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for colorectal cancer.
Treatment: Atezolizumab · Bevacizumab · Irinotecan (CPT-11) · Oxaliplatin · Leucovorin · Fluorouracil (5-FU) — The aim of this study is to evaluate the efficacy of the addition of Atezolizumab to FOLFOXIRI plus bevacizumab as first line treatment of patients with pMMR and Immunoscore IC-high metastatic colorectal cancer in terms of Progression Free Survival (PFS).
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient mismatch repair (pMMR)
Proficient mismatch repair (pMMR) status in tumour tissue (primary or metastatic), as determined by a local laboratory assay in a CLIA- or similarly certified
Required: NONE Immunoscore IC-high
Immunoscore IC-high status in tumour tissue (primary or metastatic), as determined by a sponsor-defined central laboratory (HEGP, AP-HP, INSERM, France)
Excluded: DPYD complete deficiency (homozygous c1679GG, c1905+1AA, c2846TT)
Complete dihydropyrimidine dehydrogenase (DPYD) deficiency (homozygous of the following DPYD polymorphisms: c1679GG, c1905+1AA, c2846TT)
Disease stage
Required: Stage IV
Metastatic disease required
Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease; At least one measurable lesion according to RECIST criteria (version 1.1)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: radiation therapy
Radiotherapy to any site within 4 weeks before the study
Cannot have received: oxaliplatin-containing chemotherapy
Exception: adjuvant setting
Previous adjuvant oxaliplatin-containing chemotherapy
Cannot have received: bevacizumab (bevacizumab)
Previous treatment with bevacizumab
Cannot have received: CD137 agonist
Prior treatment with CD137 agonists
Cannot have received: anti-CTLA-4 therapy
anti-CTLA4
Cannot have received: anti-PD-1 therapy
anti-PD-1
Cannot have received: anti-PD-L1 therapy
anti-PD-L1 therapeutic antibody or pathway-targeting agents
Cannot have received: investigational drug
Treatment with any investigational drug within 30 days prior to enrollment or 2 investigational agent half-lives (whichever is longer)
Lab requirements
Blood counts
Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hb >9 g/dl
Kidney function
Creatinine clearance ≥50 mL/min or serum creatinine ≤1.5 x UNL
Liver function
Total bilirubin ≤1.5 x UNL; AST (SGOT) and/or ALT (SGPT) <2.5 x UNL (or <5 x UNL in case of liver metastases); alkaline phosphatase <2.5 x UNL (or <5 x UNL in case of liver metastases)
Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hb >9 g/dl; Total bilirubin ≤1.5 x UNL; AST (SGOT) and/or ALT (SGPT) <2.5 x UNL (or <5 x UNL in case of liver metastases); alkaline phosphatase <2.5 x UNL (or <5 x UNL in case of liver metastases); Creatinine clearance ≥50 mL/min or serum creatinine ≤1.5 x UNL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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