Recruiting NCT07284849

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

Phase III Interventional CRC (Colorectal Cancer)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: INCA33890, Placebo, Bevacizumab, FOLFOX.
Who it may be relevant to: Registry conditions: CRC (Colorectal Cancer). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +16
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

Drug INCA33890
INCA33890 will be administered at protocol defined dose.
Drug Placebo
Placebo will be administered at protocol defined dose.
Drug Bevacizumab
Bevacizumab will be administered at protocol defined dose.
Drug FOLFOX
FOLFOX will be administered at protocol defined dose.

Primary outcome measures

Progression-Free Survival (PFS) [Time frame: Up to 3 years]

Secondary outcome measures (8)

Overall Survival (OS) [Time frame: Up to 4 years]
Objective response [Time frame: Up to 3 years]
Duration of Response (DOR) [Time frame: Up to 3 years]
Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 4 years]
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatmen [Time frame: Up to 4 years]
Change from baseline in EQ-5D-5L score at protocol-defined visits [Time frame: Up to 4 years]
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at protocol-defined visits [Time frame: Up to 4 years]
Change from baseline in Functional Assessment of Cancer Therapy Colorectal Symptom Index (FCSI)-9 score at protocol-defined visits [Time frame: Up to 4 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment