Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Clinical summary
Summary
The purpose of this study is to evaluate how safe and effective standard-of-care chemotherapy and bevacizumab targeted therapy is, with or without an investigational drug called INCA33890, in the first-line treatment of metastatic microsatellite stable colorectal cancer.
Who is it for?
You may be eligible for this study if you have stage IV colorectal cancer (bowel cancer) that is not able to be removed with surgery (unresectable). You must also not have had any prior systemic treatment for your unresectable or metastatic disease. If you have received adjuvant or neoadjuvant therapy you may enroll if there was no recurrence within 12 months of the end of treatment.
Study details
Eligible participants will be randomly allocated (by chance) to one of these two treatment arms:
- Experimental: INCA33890 will be administered in combination with bevacizumab targeted therapy and FOLFOX chemotherapy.
- Placebo Comparator: A placebo will be administered in combination with bevacizumab targeted therapy and FOLFOX chemotherapy.
Conditions
This trial is treating people with stage IV colorectal adenocarcinoma
Eligibility
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
- 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.
- Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years.
- Active autoimmune disease that has required systemic treatment in the past 2 years.
- Significant concurrent and/or uncontrolled medical condition.
- History of organ transplant, including allogeneic stem cell transplantation.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
Trial sponsor
Incyte Corporation
Scientific Title
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
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