IDE196 (Darovasertib) in combination with Crizotinib versus the treatment chosen by the investigator as first-line therapy for HLA-A2 negative metastatic choroidal melanoma.
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)
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)
Sponsor
non disponible
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
IDEAYA Clinical Trials
001 650-534-3616
IDEAYAClinicalTrials@clutterideayabio.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
non disponible
Titre officiel (approuvé par le comité d'éthique)
non disponible
Titre académique
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Titre public
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Maladie en cours d'investigation
non disponible
Intervention étudiée
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Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
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Date d'enregistrement
non disponible
Inclusion du premier participant
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Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
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Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
non disponible
Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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