IMCgp100-401: Rollover Study for Patients Completing an IMCgp100 study
Research type
Research Study
Full title
IMCgp100-401: An Open-label, Multi-Center, Rollover Study in Patients with Advanced Melanoma After Completing an IMCgp100 Clinical Study
IRAS ID
213489
Contact name
Mark Ross Middleton
Contact email
Sponsor organisation
Immunocore Limited
Eudract number
2016-002236-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 10 months, 16 days
Research summary
This is a rollover study for participants previously enrolled in Immunocore sponsored clinical trials for advanced melanoma which are ending (protocols IMCgp100/01, IMCgp100-201 & IMCgp100-102), in which participants were receiving the study drug IMCgp100, and the study doctor feels they should continue receiving IMCgp100. This study has been designed to provide continued access to IMCgp100 for participants with advanced melanoma meeting the inclusion criteria. This study will also look at side effects participants have while taking the IMCgp100 and how they are when they stop taking IMCgp100. The dose of IMCgp100 given will be based on what was received in the previous IMCgp100 study. This will be at weekly or monthly intervals.
The number of people diagnosed with melanoma is increasing and the outcome with current chemotherapy options is poor, therefore there is a need for new therapies. IMCgp100 is thought to work by activating the recipients own immune system against the tumour. This is effective because some cancers are able to avoid being detected by the immune system.
This research study is divided into three periods: Screening, Treatment, and Follow-up.
The Screening Period is to make sure that participants are a good fit for this study, and that this study is also a good fit for the participants. The Screening Period may last up to 3 weeks. If participants complete the Screening Period and the study doctor confirms that the participant is eligible, they will enter the Treatment Period. During the Treatment Period participants will receive IMCgp100, this will continue for the length of time the growth of the participants tumours are controlled by IMCgp100, or until the study doctor decides that it is no longer beneficial for the participant to continue receiving IMCgp100. The participants will then have an End of Treatment visit and then a follow-up period.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0511
Date of REC Opinion
22 Nov 2016
REC opinion
Further Information Favourable Opinion