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Immunterapi (Toripalimab) för att förhindra återfall efter operation för felanpassningsreparation Brist på steg IIB, IIC eller III koloncancer

30 september 2026 uppdaterad av: Oluwadunni Emiloju, Emory University

En fas II -studie av adjuvans Toripalimab i hög risk lokaliserad koloncancer med felanpassningsreparationsbrist

This phase II trial tests how well immunotherapy (toripalimab) works for reducing the risk of cancer recurrence after surgery in patients with mismatch repair deficient stage IIB, IIC, or III colon cancer.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVE:

I. Evaluate the efficacy of adjuvant toripalimab in patients with resected stage IIB, IIC, and III mismatch repair deficient (dMMR) colon cancer by measuring 3-year disease-free survival.

SECONDARY OBJECTIVES:

I. Define the immune related toxicity profile of toripalimab in the adjuvant setting.

II. Further evaluate the efficacy of adjuvant toripalimab specifically by measuring 3-year relapse free survival (RFS), 5-year disease free survival (DFS), and 5-year overall survival.

TERTIARY/EXPLORATORY OBJECTIVES:

I. To explore immune, ctDNA, and omic markers associated with clinical efficacy (DFS).

II. To assess patient reported outcomes (PRO) and health related quality of life (QoL).

OUTLINE:

Eligible consenting participants will receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months until 5 years post-resection. After completion of study medication, participants undergo surveillance follow up with blood tests, computed tomography (CT) scans, colonoscopy at specified intervals until 5 years post-resection. Patient reported outcomes and quality of life will also be assessed with questionnaires.

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30322
        • Rekrytering
        • Emory University Hospital/Winship Cancer Institute
        • Huvudutredare:
          • Oluwadunni E. Emiloju, MBBS, MS
        • Kontakt:
      • Atlanta, Georgia, Förenta staterna, 30308
        • Rekrytering
        • Emory University Hospital Midtown
        • Kontakt:
        • Huvudutredare:
          • Oluwadunni E. Emiloju, MBBS, MS
      • Atlanta, Georgia, Förenta staterna, 30342
        • Rekrytering
        • Emory Saint Joseph's Hospital
        • Huvudutredare:
          • Oluwadunni E. Emiloju, MBBS, MS
        • Kontakt:
      • Atlanta, Georgia, Förenta staterna, 30033
        • Rekrytering
        • Emory Decatur Hospital
        • Huvudutredare:
          • Oluwadunni Emiloju
        • Kontakt:
      • Johns Creek, Georgia, Förenta staterna, 30097
        • Rekrytering
        • Emory Johns Creek Hospital
        • Huvudutredare:
          • Oluwadunni E. Emiloju, MBBS, MS
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Patients with resected pathologic stage IIB, IIC and III dMMR colon cancer (American Joint Committee on Cancer [AJCC] 8)

  • Deficient mismatch repair (MMR) by immunohistochemistry or microsatellite instability (MSI-H) by polymerase chain reaction (PCR) or next generation sequencing (NGS)

  • Complete (R0) resection of pathologic stage IIB, IIC and III dMMR colon cancer 4 to 12 weeks prior to first dose of study drug

  • Available tissue sample from surgical specimen

  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2

  • Absolute neutrophil count (ANC) ≥ 1,000 /mcL

  • Platelets ≥ 75,000 / mcL

  • Hemoglobin ≥ 9 g/dL or ≥ 5.0 mmol/L

    • Transfusion is allowed to obtain an adequate hemoglobin level

  • Creatinine ≤ 1.5 x upper limit of normal (ULN) or measured or calculated creatinine clearance ≥ 40 mL/min for patient with creatinine levels > 1.5 x institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl])

    • Creatinine clearance should be calculated per institutional standard

  • Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 x ULN

    • Patients with previously diagnosed Gilbert syndrome can have total bilirubin < 3.0 mg/dL

  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 3 x ULN

  • Alkaline phosphatase ≤ 3 x ULN

  • Signed informed consent

  • Patients at least 18 years of age

  • Colonoscopy should be performed before surgery and if synchronous colon cancers are present, both must have deficient MMR and both must have undergone complete resection for patient to be eligible. If colonoscopy was not done pre-operatively, the patient may still be eligible if all other inclusion criteria are met. It should however be performed within 6 months after initial colon resection surgery

  • Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP are women younger than 55 years (yrs) of age excluding those who are surgically unable to get pregnant due to prior hysterectomy and or bilateral salpingo-oophorectomy

  • Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 90 days after the last dose of study drug. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard

  • Female patients who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 90 days after the last dose of study drug

Exclusion Criteria:

  • Neoadjuvant treatment for dMMR colon cancer
  • Presence of metastatic dMMR colon cancer
  • Underlying medical conditions that, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events
  • Uncontrolled psychiatric illness or psychological condition potentially hampering compliance with the study protocol and follow-up schedule
  • History of pneumonitis requiring treatment with steroids, or history of interstitial lung disease
  • History of prior malignancy other than the cancer under study, that is progressing or has required active treatment within the past 3 years. Exceptions include adequately treated basal cell or squamous cell carcinoma of skin, superficial bladder cancer, in situ cervical cancer, in situ breast cancer, other in situ cancers, prostate cancer with a Gleason score ≤6 that does not need therapy or other local tumors that are considered cured.
  • Autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with vitiligo, diabetes mellitus type 1, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, controlled psoriasis or resolved childhood asthma/atopy not requiring systemic treatment can be enrolled
  • Active hepatitis B or hepatitis C
  • Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
  • Treatment with live vaccines within 30 days prior to the first dose of study medication. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, nasal seasonal flu, H1N1 flu, rabies, Bacille Calmette Guerin (BCG) and typhoid vaccine
  • Prior treatment with any immune checkpoint inhibitor
  • Current pregnancy or breastfeeding

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Treatment (toripalimab)

Eligible consenting participants receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. Following this, patients undergo surveillance follow up with blood tests, computed tomography (CT) scans, colonoscopy at specified intervals until 5 years post-resection. For patients who have a recurrence, a biopsy will be performed at the time of recurrence.
Procedur: Computed Tomography

Undergo CT

Andra namn:
  • CT
  • Datortomografi
  • Datortomografi (CT) skanning
Övrig: Questionnaire Administration

Ancillary studies

Procedur: Biopsy Procedure

Undergo biopsy

Andra namn:
  • BIOPSY_TYPE
  • Biopsi
Procedur: Biospecimen Collection

Undergo collection of blood samples

Andra namn:
  • Provsamling
Procedur: Colonoscopy

Undergo colonoscopy

Läkemedel: Toripalimab

Given IV

Andra namn:
  • JS-001
  • Loqtorzi
  • Toripalimab-tpzi
  • Anti-PD-1 monoklonal antikropp JS001

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
3-year Disease free survival (DFS)
Tidsram: Time between the date of registration and the first date of documented recurrence or death due to any cause assessed up to 3 years

Time between the date of registration and the first date of documented recurrence, regardless of discontinuation of study drug, or death due to any cause, assessed at 3 years
Time between the date of registration and the first date of documented recurrence or death due to any cause assessed up to 3 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of treatment-related adverse events
Tidsram: Up to 5 years

Safety will be determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. Treatment-related adverse events (defined as potentially, probably and definitely) will be summarized in preferred term by system organ class and listed on an individual subject basis at patient level. Immune-related adverse events will also be tabulated.
Up to 5 years
3-year Relapse free survival (RFS)
Tidsram: Time between the date of registration and the first date of documented disease recurrence assessed up to 3 years.

Time between the date of registration and the first date of documented disease recurrence, assessed at 3 years
Time between the date of registration and the first date of documented disease recurrence assessed up to 3 years.
5-year DFS
Tidsram: Time between the date of registration and the first date of documented recurrence, or death due to any cause assessed up to 5 years

Time between the date of registration and the first date of documented recurrence, regardless of discontinuation of study drug, or death due to any cause, assessed at 5 years.
Time between the date of registration and the first date of documented recurrence, or death due to any cause assessed up to 5 years
Colon cancer specific survival (CCSC)
Tidsram: Time between the date of registration and the date of death due to colon cancer, assessed up to 5 years

CCSC is the time between the date of registration and the date of death due to colon cancer, assessed up to 5 years
Time between the date of registration and the date of death due to colon cancer, assessed up to 5 years
Overall survival (OS)
Tidsram: Time between the date of registration and the date of death due to any cause, assessed up to 5 years

Time between the date of registration and the date of death due to any cause.
Time between the date of registration and the date of death due to any cause, assessed up to 5 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Emory University

Samarbetspartners

National Cancer Institute (NCI)
Coherus Oncology, Inc.

Utredare

  • Huvudutredare: Oluwadunni E. Emiloju, MBBS, MS, Emory University Hospital/Winship Cancer Institute

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

19 september 2025

Primärt slutförande (Beräknad)

31 juli 2029

Avslutad studie (Beräknad)

31 december 2031

Studieregistreringsdatum

Först inskickad

22 augusti 2025

Först inskickad som uppfyllde QC-kriterierna

22 augusti 2025

Första postat (Faktisk)

25 augusti 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY00008833
  • P30CA138292 (U.S.S. NIH-anslag/kontrakt)
  • STUDY00008833 (Annan identifierare: Emory University Hospital/Winship Cancer Institute)
  • NCI-2025-05423 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • WINSHIP6483-24 (Annan identifierare: Emory University Hospital/Winship Cancer Institute)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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