CRC (Colorectal Cancer)
Conditions
Keywords
Colorectal Cancer, Colon Cancer, INCA33890, Circulating tumor DNA (ctDNA), Signatera, Minimal residual disease (MRD)
Brief summary
The purpose of this study is to evaluate INCA33890 in the treatment of circulating tumor DNA-positive stage II/III microsatellite stable colorectal cancer after curative resection and chemotherapy.
Interventions
DRUGINCA33890
INCA33890 will be administered at protocol defined dose.
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Received curative-intent (R0) resection of histologically confirmed Stage II or III colorectal adenocarcinoma. * Completed all neoadjuvant and/or adjuvant chemotherapy, including at least 3 months of fluoropyrimidine-based chemotherapy. * Has minimal residual disease (MRD), defined as ctDNA positive by the Signatera™ assay (whole exome sequencing \[WES\] or whole genome sequencing \[WGS\]) in a blood sample collected between: * 2 weeks and 12 months after completion of adjuvant chemotherapy or * 4 weeks and 12 months after curative resection following total neoadjuvant therapy. Note: If the participant received any investigational therapy for MRD, ctDNA positivity must be confirmed in a blood sample collected at least 4 weeks after completion of that investigational therapy and within the applicable 12-month window described above. * Has no clinical or radiographic evidence of disease confirmed by chest, abdominal, and pelvic PET-CT scan and by brain imaging (MRI or CT scan with contrast) within 4 weeks prior to C1D1 study drug administration. * ECOG performance status of 0 or 1. * Adequate organ function determined by laboratory results.
Exclusion criteria
* History of metastatic (Stage IV) colorectal adenocarcinoma, including oligometastatic disease or metastatic recurrence, even if all metastatic sites and the primary tumor were completely resected and the patient is currently without evidence of disease. * MSI-H/dMMR per historical data in the medical record. * History of other malignancy within 2 years. * Treatment with an anti-PD-(L)1 or anti-CTLA-4 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 |
|---|---|---|
| Circulating tumor DNA (ctDNA) clearance | 3 months | Defined as ctDNA positive at baseline and change to ctDNA negative at 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ctDNA clearance by visit | Up to approximately 19 months | Defined as ctDNA positive at baseline and change to ctDNA negative at corresponding visits. |
| Absolute change from baseline in ctDNA levels at each visit | Up to approximately 19 months | — |
| Percent change from baseline in ctDNA levels at each visit | Up to approximately 19 months | — |
| Disease-free survival (DFS) | Up to approximately 19 months | Defined as the time from the date of first dose of study drug to the date of recurrence, second primary CRC malignancy, or death from any cause, whichever occurs first. |
| Treatment Emergent Adverse Events (TEAEs) | Up to approximately 19 months | Adverse events reported for the first time or worsening of a pre-existing event, occurring after first dose of study drug and up to 90 days after last dose of INCA33890 or the start of new anticancer therapy, whichever comes first. |
| TEAEs leading to dose interruptions, dose delays or discontinuation of study treatment | Up to approximately 19 months | TEAEs leading to dose interruption, dose delay or study drug discontinuation. |
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed