Multiple Platform Melanoma Study
Research type
Research Study
Full title
A randomized, open-label, phase II open platform study evaluting the efficacy and safety of novel Spartalizumab (PDR001) combinations in previously treated unresected or metastatic melanoma
IRAS ID
246109
Contact name
Paul Nathan
Contact email
Sponsor organisation
Novartis PHarma AG
Eudract number
2018-000610-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 2 days
Research summary
This Phase II study will test the use of Spartalizumab, anti-PD-1 antibody, in combination with other drugs that may help alter the resistance developed by tumours against check point inhibitors like anti-PD1.
This study will be open to advanced melanoma participants (i.e. melanoma that can’t be removed by surgery or has spread to other parts of the body) who have received one line of treatment based on their altered protein (i.e. BRAF ) status.The study will consist of two Parts
Part 1 : Selection Phase
The objective of this part is to evaluate preliminary Overall Response Rate (ORR) of Spartalizumab in combination with other novel agents in eligible participants
The three combination arms of Part 1 of the study are as follows:
Arm 1: Spartalizumab in combination with LAG525Arm 2: Spartalizumab in combination with Capmatinib
Arm 3: Spartalizumab in combination with Canakinumab
Approximately 45 participants will be enrolled in each of the above armsPart 2 : Expansion Phase
The objective of this part of the study is to further characterize ORR of Spartalizumab combinations that have met prespecified criteria (i.e. considered futile) in Part 1Spartalizumab (400mg) and LAG525 (600mg) will be given every 4 weeks as an infusion, Canakinumab (300mg) will be administered as an injection and Capmatinib (400mg) will needs to be taken orally twice a day as a tablet.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0305
Date of REC Opinion
24 Sep 2018
REC opinion
Further Information Favourable Opinion