A Study to Evaluate the Efficacy and Safety of Standard-o... | NCT07284849

Studies
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

NCT07284849

Sponsor

Incyte Corporation

Status

Recruiting

Last Update Posted

Jul 6, 2026Actual

Enrollment

700Estimated

Phase

Phase 3

Conditions

CRC (Colorectal Cancer)

Interventions

INCA33890
Placebo
Bevacizumab
FOLFOX

Countries

United States
Argentina
Australia
Austria
Belgium
Brazil
Canada
Denmark
France
Georgia
Germany
Italy
Japan
Netherlands
Norway
Poland
Puerto Rico
South Korea
Spain
Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2025-523735-19-00	Registry Identifier	EU CT Number

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2026Actual

Primary Completion Date

Dec 29, 2028Estimated

Completion Date

Sep 28, 2029Estimated

First Submitted Date

Dec 9, 2025

First Submission Date that Met QC Criteria

Dec 9, 2025

First Posted Date

Dec 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2026

Last Update Posted Date

Jul 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
INCA33890	Experimental	INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.	Drug: INCA33890 Drug: Bevacizumab Drug: FOLFOX
Placebo	Placebo Comparator	Placebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.	Drug: Placebo Drug: Bevacizumab Drug: FOLFOX

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INCA33890	Drug	INCA33890 will be administered at protocol defined dose.	INCA33890

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-Free Survival (PFS)	Defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or death due to any cause.	Up to 3 years

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS)	Defined as the time from the date of randomization to the date of death due to any cause.	Up to 4 years
Objective response	Defined as complete response (CR) or partial response (PR) as determined by the investigator per RECIST v1.1.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Incyte Corporation Call Center (US)	Contact	1.855.463.3463		medinfo@incyte.com
Incyte Corporation Call Center (ex-US)	Contact	+800 00027423		eumedinfo@incyte.com

Overall Officials

Name	Affiliation	Role
Incyte Medical Monitor	Incyte Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ironwood Cancer & Research Centers	Withdrawn	Chandler	Arizona	85224-5665	United States

References Module

Citations

Not provided

ID	Term
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D000068258	Bevacizumab
C410216	Folfox protocol

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins