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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 (Jun 2026). This Phase 3 trial studies multiple treatments for colorectal cancer.

Phase 3RecruitingGruppo Oncologico del Nord-OvestNCT06733038Data as of Jun 2026Location: Italy

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).

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Atezolizumab

Targeted therapy

Bevacizumab

Chemotherapy

Irinotecan (CPT-11)OxaliplatinFluorouracil (5-FU)

Other

Leucovorin

Cancer type

Colorectal Cancer

Biomarker criteria

Required: Mismatch-repair proficient (pMMR / MSS)

Proficient mismatch repair (pMMR) status in tumour tissue (primary or metastatic), as determined by a local laboratory assay

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

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 75

Prior therapy

Cannot have received: adjuvant oxaliplatin-containing chemotherapy

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

Prior treatment with anti-CTLA4 therapeutic antibody or pathway-targeting agents

Cannot have received: anti-PD-1 therapy

Prior treatment with anti-PD-1 therapeutic antibody or pathway-targeting agents

Cannot have received: anti-PD-L1 therapy

Prior treatment with anti-PD-L1 therapeutic antibody or pathway-targeting agents

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 ≤1.5x ULN

Liver function

Total bilirubin ≤1.5x ULN; AST/ALT <2.5x ULN (or <5x ULN with liver metastases); alkaline phosphatase <2.5x ULN (or <5x ULN with liver metastases)

Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hb >9 g/dl; Total bilirubin ≤1.5x ULN; AST/ALT <2.5x ULN (or <5x ULN with liver metastases); alkaline phosphatase <2.5x ULN (or <5x ULN with liver metastases); Creatinine clearance ≥50 mL/min or serum creatinine ≤1.5x ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06733038 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior adjuvant oxaliplatin-containing chemotherapy, bevacizumab, CD137 agonist disqualifies patients from enrollment.

Does this trial require MLH1?

Yes, MLH1 wild-type is a required biomarker for enrollment.

Does this trial require MSH2?

Yes, MSH2 wild-type is a required biomarker for enrollment.

Does this trial require MSH6?

Yes, MSH6 wild-type is a required biomarker for enrollment.

Are patients with DPYD alterations eligible?

No. DPYD complete deficiency (homozygous c1679GG, c1905+1AA, c2846TT) is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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