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NCT Number: NCT07823322

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria apply.

Treatment and study plan

INCA33890

Drug

INCA33890 will be administered at protocol defined dose.

Primary outcomes

  1. Circulating tumor DNA (ctDNA) clearance

    Time frame: 3 months

    Defined as ctDNA positive at baseline and change to ctDNA negative at 3 months.

Secondary outcomes

  1. ctDNA clearance by visit

    Time frame: Up to approximately 19 months

    Defined as ctDNA positive at baseline and change to ctDNA negative at corresponding visits.

  2. Absolute change from baseline in ctDNA levels at each visit

    Time frame: Up to approximately 19 months

  3. Percent change from baseline in ctDNA levels at each visit

    Time frame: Up to approximately 19 months

  4. Disease-free survival (DFS)

    Time frame: 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.

  5. Treatment Emergent Adverse Events (TEAEs)

    Time frame: 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.

  6. TEAEs leading to dose interruptions, dose delays or discontinuation of study treatment

    Time frame: Up to approximately 19 months

    TEAEs leading to dose interruption, dose delay or study drug discontinuation.

Study contacts

Contact information is provided by the study sponsor or research team.

Incyte Corporation Call Center (US)

CONTACT

[email protected]

1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

[email protected]

+800 00027423

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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)

Acronym: NEXERA-204

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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