IDE196 (Darovasertib) in combination with Crizotinib versus the treatment chosen by the investigator as first-line therapy for HLA-A2 negative metastatic choroidal melanoma.
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
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)
Trial sites
Zurich
(BASEC)
Sponsor
Ideaya Biosciences, Inc
(BASEC)
Contact
Contact Person Switzerland
IDEAYA Clinical Trials
001 650-534-3616
IDEAYAClinicalTrials@clutterideayabio.comUSZ Flughafen, DER Klinische Forschung, Rämistrasse 100, CH-8091 Zürich , Switzerland
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
07.11.2023
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
IDE196 (Darovasertib) in Combination with Crizotinib Versus Investigator’s Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available