CRC (Colorectal Cancer)Phase 2NEXERA-204NCT07823322
A Study to Evaluate INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and Chemotherapy
A Phase 2 study testing INCA33890 in people with CRC (Colorectal Cancer), run by Incyte Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRC (Colorectal Cancer)
- What is being tested?
- INCA33890
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 26 Oct 2026to 14 May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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/exclusion criteria apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2 Study of INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and Chemotherapy (NEXERA-204)
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.
- Conditions
- CRC (Colorectal Cancer)
- Being tested
- INCA33890
- Keywords
- Colorectal Cancer, Colon Cancer, INCA33890, Circulating tumor DNA (ctDNA), Signatera, Minimal residual disease (MRD)
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCA33890Drug
INCA33890 will be administered at protocol defined dose.
| Study group | Role | What they receive |
|---|---|---|
| INCA33890 | Experimental | INCA33890 will be administered at the protocol-defined dose. Receives: Drug: INCA33890 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating tumor DNA (ctDNA) clearance
Defined as ctDNA positive at baseline and change to ctDNA negative at 3 months.
Measured: 3 months
Secondary outcomes (6)
ctDNA clearance by visit
Defined as ctDNA positive at baseline and change to ctDNA negative at corresponding visits.
Measured: Up to approximately 19 months
Absolute change from baseline in ctDNA levels at each visit
Measured: Up to approximately 19 months
Percent change from baseline in ctDNA levels at each visit
Measured: Up to approximately 19 months
Disease-free survival (DFS)
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.
Measured: Up to approximately 19 months
Treatment Emergent Adverse Events (TEAEs)
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.
Measured: Up to approximately 19 months
TEAEs leading to dose interruptions, dose delays or discontinuation of study treatment
TEAEs leading to dose interruption, dose delay or study drug discontinuation.
Measured: Up to approximately 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start26 Oct 2026 (estimated)
- Primary completion14 May 2029 (estimated)
- Study completion14 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC (Colorectal Cancer)Studies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823322
- Sponsor's protocol ID
- INCA033890-204
- Acronym
- NEXERA-204
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and Chemotherapy (NEXERA-204)
- ClinicalTrials.gov ID
- NCT07823322
- Acronym / sponsor ID
- NEXERA-204 / INCA033890-204
- Conditions
- CRC (Colorectal Cancer)
- Keywords
- Colorectal Cancer, Colon Cancer, INCA33890, Circulating tumor DNA (ctDNA), Signatera, Minimal residual disease (MRD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 14 May 2029 (estimated)
- Study completion
- 14 May 2029 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INCA33890 | Experimental | Drug: INCA33890INCA33890 will be administered at the protocol-defined dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCA33890INCA33890 will be administered at protocol defined dose. | Drug | INCA33890 |
Primary outcome
Circulating tumor DNA (ctDNA) clearance
Time frame: 3 months
Defined as ctDNA positive at baseline and change to ctDNA negative at 3 months.
6 secondary outcomes
ctDNA clearance by visit
Time frame: Up to approximately 19 months
Absolute change from baseline in ctDNA levels at each visit
Time frame: Up to approximately 19 months
Percent change from baseline in ctDNA levels at each visit
Time frame: Up to approximately 19 months
Disease-free survival (DFS)
Time frame: Up to approximately 19 months
Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 19 months
TEAEs leading to dose interruptions, dose delays or discontinuation of study treatment
Time frame: Up to approximately 19 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- A Study to Evaluate INCA33890 in the Treatment of Circulating Tumor DNA-Positive Stage II/III Microsatellite Stable Colorectal Cancer After Curative Resection and ChemotherapyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Incyte Medical Monitor study director
Incyte Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INCA33890 in people with CRC (Colorectal Cancer), run by Incyte Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating tumor DNA (ctDNA) clearance (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.