Bevacizumab + INCA33890 for Colorectal Cancer

Recruiting at 196 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Incyte Corporation

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

This trial is for adults with stage IV colorectal cancer that can't be surgically removed. They should have measurable disease, be relatively active and well (ECOG 0 or 1), and not have had previous treatments for advanced cancer. If they've had adjuvant therapy, there must be no recurrence within a year.

Inclusion Criteria

My organ functions are within normal ranges according to recent tests.

My colorectal cancer is at stage IV and cannot be surgically removed.

I haven't had systemic treatment for my advanced cancer, and if I had adjuvant or neoadjuvant therapy, I've been recurrence-free for 12 months.

What Are the Treatments Tested in This Trial?

Interventions

• Bevacizumab
• FOLFOX
• INCA33890

Trial Overview

The study tests if adding INCA33890 to standard chemotherapy (FOLFOX) and Bevacizumab improves outcomes in first-line treatment of metastatic microsatellite stable colorectal cancer. Participants will either receive the new combination or the standard treatment plus a placebo.

How Is the Trial Designed?

Group I: INCA33890 Experimental Treatment 3 Interventions

INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.

Group II: Placebo Placebo Group 3 Interventions

Placebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School