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Clinical Trials in the EU / 2025-523735-19-00
Authorised, recruiting Phase III

A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

2025-523735-19-00 · tracked via the Priya Life Science EU tracker
Sponsor type
Pharmaceutical company
Therapeutic area
Neoplasms
Decision date
19/05/2026
Enrollment target
292
Sites
Poland, France, Denmark, Norway, Spain, Germany, Belgium, Netherlands, Austria, Italy

Condition studied

Metastatic Microsatellite Stable Colorectal Cancer

Investigational medicinal product(s)

BEVACIZUMABFLUOROURACILOXALIPLATININCA33890Placebo contains the same formulation buffer10 mM acetate9% (w/v) sucrose and 0.02% (w/v) polysorbate 80at pH 5.5without the active pharmaceutical ingredient.CALCIUM FOLINATE

Every trial of INCA33890, Calcium folinate, Fluorouracil and Oxaliplatin across our registers →

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

PFS, defined as the time from the date of randomization to the date of the first documented progression as determined by BICR (Blinded Independent Central Review) per RECIST v1.1 or death due to any cause.

Endpoint detail

OS, defined as the time from the date of randomization to the date of death due to any cause., Objective response, defined as CR or PR as determined by BICR (Blinded Independent Central Review) per RECIST v1.1., DOR, defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by BICR per RECIST v1.1 or death due to any cause, whichever occurs first., TEAEs per CTCAE v6.0 and TEAEs leading to dose interruption or study drug discontinuation.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523735-19-00 on CTIS ↗ ← All trials in the EU