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Immunothérapie (Toripalimab) pour prévenir la récidive après la chirurgie pour la réparation de mésappariement Stade déficient IIB, IIC ou III Colon Cancer du côlon

30 septembre 2026 mis à jour par: Oluwadunni Emiloju, Emory University

Un essai de phase II du toripalimab adjuvant dans un cancer du côlon localisé à haut risque avec une carence en réparation de mésappariement

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Georgia
      • Atlanta, Georgia, États-Unis, 30322
        • Recrutement
        • Emory University Hospital/Winship Cancer Institute
        • Chercheur principal:
          • Oluwadunni E. Emiloju, MBBS, MS
        • Contact:
      • Atlanta, Georgia, États-Unis, 30308
        • Recrutement
        • Emory University Hospital Midtown
        • Contact:
        • Chercheur principal:
          • Oluwadunni E. Emiloju, MBBS, MS
      • Atlanta, Georgia, États-Unis, 30342
        • Recrutement
        • Emory Saint Joseph's Hospital
        • Chercheur principal:
          • Oluwadunni E. Emiloju, MBBS, MS
        • Contact:
      • Atlanta, Georgia, États-Unis, 30033
        • Recrutement
        • Emory Decatur Hospital
        • Chercheur principal:
          • Oluwadunni Emiloju
        • Contact:
      • Johns Creek, Georgia, États-Unis, 30097
        • Recrutement
        • Emory Johns Creek Hospital
        • Chercheur principal:
          • Oluwadunni E. Emiloju, MBBS, MS
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: Computed Tomography

Undergo CT

Autres noms:
  • TDM
  • Tomographie assistée par ordinateur
  • Tomodensitométrie
  • Tomodensitométrie (TDM)
Autre: Questionnaire Administration

Ancillary studies

Procédure: Biopsy Procedure

Undergo biopsy

Autres noms:
  • BIOPSIE_TYPE
  • Biopsie
Procédure: Biospecimen Collection

Undergo collection of blood samples

Autres noms:
  • Collecte de spécimens
Procédure: Colonoscopy

Undergo colonoscopy

Médicament: Toripalimab

Given IV

Autres noms:
  • JS-001
  • Loqtorzi
  • Toripalimab-tpzi
  • Anticorps monoclonal anti-PD-1 JS001

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
3-year Disease free survival (DFS)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Incidence of treatment-related adverse events
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Emory University

Collaborateurs

National Cancer Institute (NCI)
Coherus Oncology, Inc.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 septembre 2025

Achèvement primaire (Estimé)

31 juillet 2029

Achèvement de l'étude (Estimé)

31 décembre 2031

Dates d'inscription aux études

Première soumission

22 août 2025

Première soumission répondant aux critères de contrôle qualité

22 août 2025

Première publication (Réel)

25 août 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STUDY00008833
  • P30CA138292 (Subvention/contrat des NIH des États-Unis)
  • STUDY00008833 (Autre identifiant: Emory University Hospital/Winship Cancer Institute)
  • NCI-2025-05423 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • WINSHIP6483-24 (Autre identifiant: Emory University Hospital/Winship Cancer Institute)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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