IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

Launched by IDEAYA BIOSCIENCES · Aug 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new combination treatment for people with metastatic uveal melanoma (a type of eye cancer that has spread to other parts of the body). The trial is comparing a treatment called IDE196 (Darovasertib) combined with crizotinib to other standard treatments like pembrolizumab, ipilimumab + nivolumab, or dacarbazine. It aims to see if the new combination can be more effective as a first-line therapy for patients who have not yet received treatment for their advanced cancer.

To participate in this trial, patients need to be diagnosed with metastatic uveal melanoma and have a specific genetic marker (HLA-A*02:01 negative). They should not have received previous systemic treatments for their cancer and must have measurable disease. Participants can expect regular check-ups and monitoring during the trial to assess how well the treatment is working and to manage any side effects. It’s important to note that there are some exclusions, such as having certain other health conditions or previous treatments that could affect the trial's outcomes. If you or a loved one is interested in this trial, it could be a potential option for treatment in the fight against metastatic uveal melanoma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histological or cytological confirmed Metastatic Uveal Melanoma
• • HLA-A\*02:01 negative
• • No prior systemic therapy in the metastatic or advanced setting or regional or liver-directed therapy. Ablations or surgical resection of oligometastatic disease, and neoadjuvant or adjuvant therapy is allowed
• • Measurable disease per RECIST 1.1
• • Able to be safely administered and absorb study therapy
• • ECOG performance status 0 or 1
• • Life expectancy of ≥3 months
• • Adequate organ function
• Exclusion Criteria:
• • Previous treatment with a PKC inhibitor (including prior treatment with IDE196), an inhibitor directly targeting MET, or an inhibitor directly targeting GNAQ/11
• • Concurrent malignant disease
• • AEs from prior anti-cancer therapy that have not resolved to Grade ≤1
• • Symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require corticosteroids
• • High risk of syncope
• • Known AIDS related illness or active Hep B/C
• • Active adrenal insufficiency, active colitis, or active inflammatory bowel disease
• • History of interstitial lung disease, active pneumonitis, or history of pneumonitis
• • Active infection requiring systemic antibiotic therapy
• • Use of hematopoietic colony-stimulating factors (CSF) prior to start of study drug
• • Females who are pregnant or breastfeeding
• • History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
• • Contraindication for treatment with investigator's choice therapies as per applicable labelling
• • History of stroke within the last 6 months of the first dose of study drug
• • Has any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the opinion of the investigator, would make the participant inappropriate for entry into the study, including institutionalization on the basis of an official or court order