CRC (Colorectal Cancer)
Conditions
Keywords
Metastatic Colorectal Cancer, Colon Cancer, INCA33890
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.
Interventions
DRUGINCA33890
INCA33890 will be administered at protocol defined dose.
DRUGPlacebo
Placebo will be administered at protocol defined dose.
DRUGBevacizumab
Bevacizumab will be administered at protocol defined dose.
DRUGFOLFOX
FOLFOX will be administered at protocol defined dose.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | Up to 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to 4 years | Defined as the time from the date of randomization to the date of death due to any cause. |
| Objective response | Up to 3 years | Defined as complete response (CR) or partial response (PR) as determined by the investigator per RECIST v1.1. |
| Duration of Response (DOR) | Up to 3 years | Defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by the investigator per RECIST v1.1 or death due to any cause, whichever occurs first. |
| Treatment Emergent Adverse Events (TEAEs) | Up to 4 years | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment, up to 90 days after the last dose INCA33890/placebo (or 30 days after the last dose of any FOLFOX component or bevacizumab if later) or the start of new anticancer therapy, whichever comes first. |
| TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatmen | Up to 4 years | TEAEs leading to dose interruption or study drug discontinuation. |
| Change from baseline in EQ-5D-5L score at protocol-defined visits | Up to 4 years | The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health). |
| 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 | Up to 4 years | The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in cancer patients. It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. |
| Change from baseline in Functional Assessment of Cancer Therapy Colorectal Symptom Index (FCSI)-9 score at protocol-defined visits | Up to 4 years | The FCSI-9 is a 9-item questionnaire derived from the FACT-C questionnaire to be a briefer, more targeted symptom-specific measure for patients with CRC. The FCSI-9 assesses common symptoms of CRC, including energy, pain, weight loss, nausea, diarrhea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The questionnaire is scored to produce a single total score, with a higher score indicating less symptoms. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Georgia, Germany, Italy, Japan, Netherlands, Norway, Poland, Puerto Rico, South Korea, Spain, Switzerland, United Kingdom, United States
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed