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 (NEXERA-204)
11. september 2026 oppdatert av: Incyte Corporation
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
40
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Incyte Corporation Call Center (US)
- Telefonnummer: 1.855.463.3463
- E-post: medinfo@incyte.com
Studer Kontakt Backup
- Navn: Incyte Corporation Call Center (ex-US)
- Telefonnummer: +800 00027423
- E-post: eumedinfo@incyte.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: INCA33890
INCA33890 will be administered at the protocol-defined dose.
|
INCA33890 vil bli administrert med protokolldefinert dose.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Circulating tumor DNA (ctDNA) clearance
Tidsramme: 3 months
|
Defined as ctDNA positive at baseline and change to ctDNA negative at 3 months.
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
ctDNA clearance by visit
Tidsramme: Up to approximately 19 months
|
Defined as ctDNA positive at baseline and change to ctDNA negative at corresponding visits.
|
Up to approximately 19 months
|
|
Absolute change from baseline in ctDNA levels at each visit
Tidsramme: Up to approximately 19 months
|
Up to approximately 19 months
|
|
|
Percent change from baseline in ctDNA levels at each visit
Tidsramme: Up to approximately 19 months
|
Up to approximately 19 months
|
|
|
Disease-free survival (DFS)
Tidsramme: 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.
|
Up to approximately 19 months
|
|
Treatment Emergent Adverse Events (TEAEs)
Tidsramme: 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.
|
Up to approximately 19 months
|
|
TEAEs leading to dose interruptions, dose delays or discontinuation of study treatment
Tidsramme: Up to approximately 19 months
|
TEAEs leading to dose interruption, dose delay or study drug discontinuation.
|
Up to approximately 19 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Incyte Medical Monitor, Incyte Corporation
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
26. oktober 2026
Primær fullføring (Antatt)
14. mai 2029
Studiet fullført (Antatt)
14. mai 2029
Datoer for studieregistrering
Først innsendt
11. september 2026
Først innsendt som oppfylte QC-kriteriene
11. september 2026
Først lagt ut (Faktiske)
16. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer etter nettsted
- Neoplasmer
- Tarmsykdommer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Kolonsykdommer
- Neoplastiske prosesser
- Patologiske tilstander, tegn og symptomer
- Kolorektale neoplasmer
- Neoplasma, rest
- Kolon neoplasmer
Andre studie-ID-numre
- INCA033890-204
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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
IPD-delingstidsramme
Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Tilgangskriterier for IPD-deling
Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com
website.
For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .