Informations générales
  • Catégorie de maladie Cancer de la tête et du cou , Mélanome , Maladies de l'œil (BASEC)
  • État du recrutement Inconnu (BASEC/ICTRP)
  • Lieu de l’étude
    Zurich
    (BASEC)
  • Responsable de l'étude IDEAYA Clinical Trials IDEAYAClinicalTrials@ideayabio.com (BASEC)
  • Source(s) de données BASEC: Importé de 14.03.2025 ICTRP: N/A
  • Date de mise à jour 14.03.2025 10:30
HumRes65818 | SNCTP000006094 | BASEC2023-01759

IDE196 (Darovasertib) in combination with Crizotinib versus the treatment chosen by the investigator as first-line therapy for HLA-A2 negative metastatic choroidal melanoma.

  • Catégorie de maladie Cancer de la tête et du cou , Mélanome , Maladies de l'œil (BASEC)
  • État du recrutement Inconnu (BASEC/ICTRP)
  • Lieu de l’étude
    Zurich
    (BASEC)
  • Responsable de l'étude IDEAYA Clinical Trials IDEAYAClinicalTrials@ideayabio.com (BASEC)
  • Source(s) de données BASEC: Importé de 14.03.2025 ICTRP: N/A
  • Date de mise à jour 14.03.2025 10:30

Résumé de l'étude

This study compares two different treatments for people with a certain type of eye cancer that has spread. One treatment combines two drugs, while the other treatment is decided by the physician. The study examines which treatment is better suited as the first option for patients with this type of cancer.

(BASEC)

Intervention étudiée

All treatments are administered in cycles of 3 weeks. IDE196 200 mg or 300 mg and Crizotinib 200 mg are taken twice daily. In the first week, IDE196 is taken alone before being combined with Crizotinib. For the approved treatment at the physician's discretion, Pembrolizumab, Ipilimumab plus Nivolumab, or Dacarbazine may be selected. When Ipilimumab plus Nivolumab is administered, the cycles switch after the first 4 cycles of Ipilimumab plus Nivolumab to 4-week cycles of Nivolumab alone.

(BASEC)

Maladie en cours d'investigation

HLA-A2 negative metastatic choroidal melanoma.

(BASEC)

Critères de participation
1. Patients must be at least 18 years old. 2. This study is intended for patients with choroidal melanoma that has spread outside the eye and has not been previously treated with any other therapy (e.g., chemotherapy) and no local therapy (e.g., targeting the liver) for a disease that has spread outside the eye. 3. Prior therapy is allowed if it was administered to cure a localized disease (e.g., in the eye). (BASEC)

Critères d'exclusion
1. Prior treatment with a PKC inhibitor (including prior treatment with IDE196) or an inhibitor that directly targets MET or GNAQ/11. 2. Any other malignant disease not treated in this study. Exceptions to this exclusion criterion are: malignancies that have been treated curatively and have not recurred within 2 years prior to the study treatment; completely resected basal cell and squamous cell carcinomas of the skin; any malignancies considered indolent that have never required therapy; as well as any completely resected carcinoma in situ of any type. 3. An adverse event (AE) due to prior cancer therapy that has not resolved to ≤ grade 1, except for alopecia or anemia. • Any persistent diarrhea must be discussed with the sponsor's Medical Monitor. • Endocrinopathies resulting from prior immunotherapy are considered part of the medical history and not an AE. • A stable neuropathy of grade 2 is allowed. (BASEC)

Lieu de l’étude

Zurich

(BASEC)

non disponible

Sponsor

non disponible

Contact pour plus d'informations sur l'étude

Personne de contact en Suisse

IDEAYA Clinical Trials

001 650-534-3616

IDEAYAClinicalTrials@ideayabio.com

(BASEC)

Informations scientifiques

non disponible

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale de Zurich

(BASEC)

Date d'approbation du comité d'éthique

07.11.2023

(BASEC)


Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
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Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai

Résumé des résultats

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Lien vers les résultats dans le registre primaire

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