IMM60 & pembrolizumab in Melanoma and NSCLC
Research type
Research Study
Full title
A phase 1 first-in-human dose finding/randomised phase 2 study of IMM60 and pembrolizumab in advanced melanoma and NSCLC
IRAS ID
286317
Contact name
Ian B Walters
Contact email
Sponsor organisation
iOx Therapeutics, Ltd.
Eudract number
2020-001351-41
ISRCTN Number
ISRCTN80472712
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The aim of the IMP-MEL trial is to:
>Establish the safe dose of the experimental drug, called IMM60.
>Establish that the safe dose of IMM60 can be safely given with an existing drug already used in the treatment of melanoma and non-small cell lung cancer (NSCLC) called pembrolizumab.
>Explore if IMM60 in combination with pembrolizumab is a more effective than pembrolizumab alone.
>Explore if IMM60 can promote anti-tumour activity in non-small cell lung cancer tumours and melanoma in settings where pembrolizumab has been considered ineffective.IMM60 has not been combined with pembrolizumab before to treat NSCLC and melanoma patients. This trial will initially test a low dose of IMM60 in the first few patients. The starting dose has been selected based on information from animal studies. If tolerated the dose will increase up to a pre-defined maximum dose (using a "3 + 3" phase 1 dose escalation design). Once this dose is determined, an IMM60 dose one level lower than the maximum tolerated dose (MTD) will be combined with the standard dose of pembrolizumab and given to 3 patients to establish that the combination is safe. If so, the maximum tolerated IMM60 dose level will then be combined with the standard of dose of pembrolizumab and given to 3 additional patients again to establish the safety of this combination at this dose level.
With this information, IMM60 in combination with pembrolizumab will be compared to pembrolizumab alone in the second phase of the project. If the combination is more effective, then a larger trial may be conducted to prove if the combination of IMM60 and pembrolizumab should become a new standard treatment option for patients.
Phase 1 patients will be recruited from Churchill hospital, Oxford; Phase 2 will recruited from a further 3 UK hospital sites. The trial is funded by iOx Therapeutics, in addition to funding from the NIHR Biomedical Research Centre (Oxford Cancer Theme).REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0367
Date of REC Opinion
23 Nov 2020
REC opinion
Further Information Favourable Opinion