IDE196 (Darovasertib) in combination with Crizotinib versus the treatment chosen by the investigator as first-line therapy for HLA-A2 negative metastatic choroidal melanoma.
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
non disponibile
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
IDEAYA Clinical Trials
001 650-534-3616
IDEAYAClinicalTrials@clutterideayabio.com(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
07.11.2023
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
non disponibile
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
non disponibile
Disegno dello studio
non disponibile
Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
non disponibile
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile