Tests a new drug added to chemotherapy for advanced bowel cancer
Tests INCA33890 with chemotherapy and bevacizumab in adults with advanced colorectal cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Batumi, Kutaisi, Marneuli, and Tbilisi, GeorgiaSee the 14 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage IV colorectal cancer that has spread and cannot be removed by surgery, and who have not yet had treatment for it.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Stage IV colorectal adenocarcinoma that cannot be removed by surgery meant to remove all of the disease. The disease must be measurable on scans (RECIST v1.1). Performance status (ECOG) of 0 or 1. Organ function must be adequate on lab tests.
- Earlier treatment
- No earlier systemic treatment for cancer that cannot be removed or has spread. Treatment given before or after surgery is allowed if the cancer did not return within 12 months of the end of that treatment.
- Biomarker or test result
- The cancer must be microsatellite stable (MSS). Tumours with MSI-H/dMMR or a BRAF V600E mutation, as shown in the medical record, are not allowed.
Main reasons for not taking part
- Brain or spinal cord (CNS) metastases that are untreated or growing
- Another cancer within the past 2 years
- Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor in the last 3 years
- Active autoimmune disease that needed systemic treatment in the past 2 years
- Earlier organ transplant, including stem cell transplant from a donor
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How many different drug treatment plans (such as chemotherapy) have you had for cancer that has spread?
- Has a test of your tumour shown a change (mutation) in the KRAS, NRAS or BRAF genes?
- Has a test shown that your tumour is 'MSI-high' or 'dMMR'?
- Which best describes how well you can look after yourself and be active?
Source: NCT07284849, who can take part
Where in Georgia
- High Technology Hospital MedcenterBatumi, GeorgiaTaking people
- Jsc Evex HospitalsKutaisi, GeorgiaTaking people
- Aversi Clinic LtdMarneuli, GeorgiaTaking people
- "TIM - Tbilisi Institute of Medicine" LTDTbilisi, GeorgiaNot yet recruiting
- Archangel St. Michael Multi Profile Clinical HospitalTbilisi, GeorgiaNot yet recruiting
- Cancer Research Center LtdTbilisi, GeorgiaNot yet recruiting
- Caucasus Medical Centre LLCTbilisi, GeorgiaTaking people
- Innova LLCTbilisi, GeorgiaNot yet recruiting
- Institute of Clinical Oncology LtdTbilisi, GeorgiaTaking people
- Israel-Georgian Medical Research Clinic HelsicoreTbilisi, GeorgiaTaking people
- K. Eristavi National Center of Experimental and Clinical SurgeryTbilisi, GeorgiaTaking people
- Medulla Chemotherapy and Immunotherapy ClinicTbilisi, GeorgiaTaking people
- Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLCTbilisi, GeorgiaTaking people
- Todua Clinic LLCTbilisi, GeorgiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Incyte Corporation
- Trial code
- NCT07284849EU 2025-523735-19-00
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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; Adequate organ function determined by laboratory results.
Exclusion: Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years; Significant concurrent and/or uncontrolled medical condition; History of other malignancy within 2 years; Active autoimmune disease that has required systemic treatment in the past 2 years; History of organ transplant, including allogeneic stem cell transplantation; Other protocol-defined inclusion/exclusion criteria apply; 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.