LXH254 combinations in unresectable or metastatic melanoma
Research type
Research Study
Full title
A randomized, open-label, multi-arm, two-part, phase II study to assess the efficacy and safety of multiple LXH254 combinations in patients with previously treated unresectable or metastatic BRAFV600 or NRAS mutant melanoma
IRAS ID
284249
Contact name
Heather Shaw
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-000873-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 27 days
Research summary
A study to find out more about a new study treatment called LXH254 in combination with LTT462 or trametinib or ribociclib. This study is being done to learn how LXH254 + LTT462 or LXH254 + trametinib or LXH254 + ribociclib works and how safe it is in people with unresectable or metastatic BRAFV600 or NRAS mutant melanoma.
This study has two parts:
Part 1, 180 participants will receive one of the combinations. Participants have a 1 in 3 chance of receiving one of these combinations.
Part 2, participants will receive one of the combinations that were found to be safe and had beneficial effects in Part 1.About 320 adults/children/teenagers aged 12 years and older will take part.
All study drugs are pills taken by mouth.
Each 28 day period is known as a “cycle.”
Participants will visit the hospital for a screening visit(s), three times during cycle 1, three times during cycle 2, twice during cycle 3 and once during each cycle after cycle 3.
Up to four visits a year might be on the telephone after participants complete the study treatment.
It is not known how long participants will remain in the study because each participant may respond differently to the study treatment.
Participants will take part until their disease worsens, they experience unacceptable side effects, they or their doctor decide(s) that they should no longer take part or they have completed the 30-day safety follow-up or the 120-day pregnancy follow-up, as applicable.
Taking part may not benefit patients directly, but we may learn new things that could help treat patients in the future.
The study is being organised/funded by Novartis Pharma AG and run by medical staff in hospital.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0980
Date of REC Opinion
14 Oct 2020
REC opinion
Further Information Favourable Opinion