IDE196-002 Study
Research type
Research Study
Full title
IDE196 (DAROVASERTIB) IN COMBINATION WITH CRIZOTINIB VERSUS INVESTIGATOR’S CHOICE OF TREATMENT AS FIRST-LINE THERAPY IN HLA-A2 NEGATIVE METASTATIC UVEAL MELANOMA
IRAS ID
1008602
Contact name
Lillian Chu
Contact email
Sponsor organisation
Ideaya Biosciences, Inc
Eudract number
2023-506686-66
ISRCTN Number
ISRCTN11391038
Clinicaltrials.gov Identifier
Research summary
The experimental study medications used in this trial are IDE196 (darovasertib) together with crizotinib.
IDE196 is an investigational (experimental) new medication which blocks a protein in your body called Protein Kinase C (PKC). Approximately 90% of patients with uveal melanoma have a genetic mutation in GNAQ/GNA11 which results in abnormal activity in PKC. The tumour may depend on the effects of PKC in order to survive and grow. By blocking PKC with IDE196, it is hoped that tumour growth and tumour size may be reduced. IDE196 has not been approved by the UK Medicines and Healthcare products Regulatory Agency or any other regulatory authorities in the world. IDE196 has been studied in two other clinical trials in Australia, Europe, and North America and has been shown to be tolerable.
Crizotinib (also marketed as Xalkori) is an approved medication used to treat a certain kind of lung cancer but has not yet been approved to treat metastatic uveal melanoma. Although crizotinib has been approved for use in lung cancer by the MHRA and certain other health authorities, it has not been approved for use when combined with IDE196. Crizotinib blocks a protein called mesenchymal epithelial transition factor (MET). If MET is overactive, it can cause abnormal growth and survival of tumour cells. Most uveal melanomas have increased expression of MET which is thought to contribute to both the growth and spread of uveal melanomas.
Some participants who enroll in this study will be assigned to receive a standard-of-care treatment (the usual treatment given by your study doctor for metastatic uveal melanoma) instead of the experimental treatment. They will either receive a medication called Pembrolizumab, or a medication called Dacarbazine or a combination of two medications called Ipilimumab plus Nivolumab.REC name
Wales REC 2
REC reference
23/WA/0293
Date of REC Opinion
1 Dec 2023
REC opinion
Further Information Favourable Opinion