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

Incyte

Status and phase: Begins enrollment this month; Phase 3

Conditions: CRC (Colorectal Cancer)

Treatments: Drug: INCA33890; Drug: Placebo; Drug: FOLFOX; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07284849

2025-523735-19-00 (Registry Identifier)

INCA033890-303

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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700 participants in 2 patient groups, including a placebo group

INCA33890

Experimental group

Description:

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

Treatment:

Drug: Bevacizumab

Drug: FOLFOX

Drug: INCA33890

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Bevacizumab

Drug: FOLFOX

Drug: Placebo