IMCgp100-102 Phase 1 IMCgp100 in patients with Advanced Uveal Melanoma
Research type
Research Study
Full title
A Phase I Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 using the Intra-patient Escalation Dosing Regimen in Patients with Advanced Uveal Melanoma.
IRAS ID
194345
Contact name
Paul Nathan
Contact email
Sponsor organisation
Immunocore, Ltd.
Eudract number
2015-004222-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Summary of Research
This is a Phase I Open-label, Multi-centre study of the safety and efficacy of IMCgp100 using the Intra-patient escalation dosing regimen in patients with advanced uveal melanoma (eye cancer).The study will be run at 5 study centres in 2 countries (the UK and the USA).
The main objective of the Phase I study is to identify the Maximum Tolerated Dose (MTD) and/or the Recommended Phase II Dose (RP2D) of IMCgp100 in the weekly intra-patient escalation dosing regimen (RP2D-IE). Once the appropriate dose for phase 2 is identified (RP2D-IE), an expansion cohort in uveal melanoma will begin to further characterise the safety, tolerability, PK and preliminary efficacy of the intra-patient escalation regimen.
Participants will receive treatment with single-agent IMCgp100 administered on a weekly basis with an intra-patient escalation dosing regimen. In the first two weeks patients will receive IMCgp100 at the flat dose of 40 mcg per week. After this initial dosing period (in the third week and beyond) patients will receive an escalated dose of IMCgp100 according to the cohort into which they are enrolled. This escalated dose administered at C1D15 will be the dose used for the remainder of the treatment period unless dose reduction is implemented for toxicity. Patients who discontinue treatment will then enter a Follow-up period.
The study drug, IMCgp100 is a bi-specific protein, which can refocus a T cell against the gp100 protein that is seen in uveal melanoma cells. T cell is a type of white blood cell that is of key importance to the immune system and is at the core of adaptive immunity, the system that tailors the body's immune response to specific pathogens.
In this study, it is hoped that IMCgp100 will work by drawing T cells into the tumours and activate the T cells to trigger an effective immune response against the tumour.
Summary of Results
The safety profile of tebentafusp monotherapy was favorable and consistent with its mechanism of action. Adverse events generally resolved and were manageable with appropriate supervision and medical treatment. Tebentafusp demonstrated clinically noticeable improvement, as evidenced by extended response to therapy and survival, in patients with metastatic uveal melanoma (mUM) for whom no proven standard of care exists.REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0043
Date of REC Opinion
7 Mar 2016
REC opinion
Further Information Favourable Opinion