A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncyte Corporation

About this trial

The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.

Eligibility criteria

Qualifiers

Stage IV colorectal adenocarcinoma not amenable to curative resection.

No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment.

Measurable disease per RECIST v1.1.

ECOG performance status of 0 or 1.

Disqualifiers

MSI-H/dMMR per historical data in the medical record.

BRAF V600E mutation per historical data in the medical record.

Untreated and/or progressing CNS metastases.

History of other malignancy within 2 years.

Trial design

Treatments tested in this trial

  • INCA33890
  • Placebo
  • Bevacizumab
  • FOLFOX

Treatment groups

700 Participants
are divided into 2 treatment groups

Locations

275
Argentina
Hospital Britanico de Buenos Aires01280, Buenos Aires Argentina
Instituto Medico Especializado Alexander FlemingC1426ANZ, Buenos Aires Argentina
Investigaciones Clinicas Moleculares Icm01425, Buenos Aires Argentina
Centro Medico AustralC1019ABS, Ciudad Autonoma Buenos Aires Argentina

Sponsors and collaborators

Incyte Corporation

Lead sponsor