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COLIBRI-GI_Randomized phase 2 study of second-line chemotherapy comparing FOLFIRI + ivonescimab versus FOLFIRI + bevacizumab in Microsatellite Stable (MSS)/ proficient MisMatch Repair (pMMR) BRAF wild type (wt) advanced colorectal cancer (mCRC) without liver metastases

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524215-36-00
Enrollment
130
Registered
2026-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with non resectable pMMR/MSS BRAF wt mCRC, without liver metastasis in the secondline setting after first-line FOLFOX-based chemotherapy

Brief summary

PFS is defined as the time from the date of randomization to the date of first documentation of disease progression as assessed by the investigator according to RECIST1.1, or death from any cause, or date of last follow-up for alive non progressive patients.

Detailed description

PFS as per iRECIST is defined as the time from the date of randomization to the date of first documentation of disease progression as assessed by the investigator according to iRECIST, or death from any cause, or date of last follow-up for alive non progressive patients., ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1., DOR is defined as the time from first documented PR or CR (compared to baseline measurement taken at screening) until the date of PD, as assessed by the investigator according to RECIST v1.1, or death from any cause., OS is defined as the time from randomization to death from any cause. Patients who are alive at the data-cutoff date will be censored on the last known alive date., Toxicity / Adverse events (AEs), occurrence of treatment-related AEs, treatment-related AEs (TRAEs) leading to dose reduction or discontinuation during treatment, serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs), immune-related AEs (irAEs) graded according to NCI-CTCAE V6.0, QoL is assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-C30 and EORTC QLQ-CR29

Interventions

DRUGBEVACIZUMAB
DRUGFOLINIC ACID
DRUGivonescimab
DRUGFLUOROURACIL
DRUGIRINOTECAN

Sponsors

Unicancer
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression as assessed by the investigator according to RECIST1.1, or death from any cause, or date of last follow-up for alive non progressive patients.

Secondary

MeasureTime frame
PFS as per iRECIST is defined as the time from the date of randomization to the date of first documentation of disease progression as assessed by the investigator according to iRECIST, or death from any cause, or date of last follow-up for alive non progressive patients., ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1., DOR is defined as the time from first documented PR or CR (compared to baseline measurement taken at screening) until the date of PD, as assessed by the investigator according to RECIST v1.1, or death from any cause., OS is defined as the time from randomization to death from any cause. Patients who are alive at the data-cutoff date will be censored on the last known alive date., Toxicity / Adverse events (AEs), occurrence of treatment-related AEs, treatment-related AEs (TRAEs) leading to dose reduction or discontinuation during treatment, serious adverse eve

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 12, 2026