IMCgp100-201 Phase 1b/2 IMCgp100 in combination or alone
Research type
Research Study
Full title
A Phase Ib/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 in Combination with Durvalumab (MEDI4736) or Tremelimumab or the Combination of Durvalumab and Tremelimumab Compared to IMCgp100 Alone in Patients with Advanced Melanoma
IRAS ID
190915
Contact name
Mark Middleton
Contact email
Sponsor organisation
Immunocore, Ltd.
Eudract number
2015-002971-12
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 10 days
Research summary
The purpose of this study is to characterise the safety, tolerability, pharmacokinetics (PK - the way that the body handles the drug i.e. absorbs, circulates, breaks down and eliminates it), pharmacodynamics (how the body reacts to the drug), and anti-tumour activity of IMCgp100 in combination with durvalumab (MEDI4736, programmed death-ligand 1 [PD-L1 - a transmembrane protein that is thought to suppress the immune system] inhibitor), tremelimumab (CLTA-4 [a protein receptor that, functioning as an immune checkpoint, suppresses the immune system] inhibitor), and the combination of durvalumab with tremelimumab compared to single-agent IMCgp100 alone in patients with advanced melanoma.
The study is divided into two sections: Phase 1b and Phase 2. As many as 40 patients will take part in Phase 1b and at least 110 patients will take part in Phase 2. The study will be run at 21 study centres in five countries.
The Phase 1b portion of the study will establish the recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD) and consists of 3 Arms; Arm 1 (doublet), durvalumab combined with IMCgp100, Arm 2 (doublet), tremelimumab combined with IMCgp100 and Arm 3 (triplet) durvalumab + tremelimumab combined with IMCgp100.
The Phase 2 portion will begin once the RP2D is identified for one of the three Phase 1b combination Arms. The Phase 2 portion will assess a) the safety and effectiveness of the study drug when used in combination with one or two other investigational medications; b) how people’s bodies respond to the study medications; and c) what happens to the study medications as it moves through a person’s body.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0006
Date of REC Opinion
4 Feb 2016
REC opinion
Further Information Favourable Opinion