Tebentafusp Regimen Versus Investigator’s Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Research type
Research Study
Full title
A Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator’s Choice in HLA A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM)
IRAS ID
1007404
Contact name
Nicola McKelvie
Contact email
Sponsor organisation
Immunocore Ltd.
Clinicaltrials.gov Identifier
Research summary
This research study will compare tebentafusp (study medicine), alone and in combination with pembrolizumab (already licenced treatment of advance melanoma) with investigator’s choice treatment in previously treated advanced melanoma to determine whether the study medicine helps patients with advanced melanoma live longer. Another main purpose of the study is to learn if a blood test called "Signatera" shows which patients respond to treatment and live longer. The Signatera test measures traces of cancer in the blood and checks for changes during treatment.
For phase 2, approximately 176 participants will be screened to achieve 120 participants randomised for an estimated 108 evaluable participants for the Signatera blood test. For phase 3, approximately 750 participants will be screened to achieve 510 randomised study participants. Participants must be at least 18 years old with previously treated advanced melanoma.
The study is planned to last for about 2 years and 3 months (2 years treatment and 3 months long term follow up).
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
23/EM/0096
Date of REC Opinion
29 Aug 2023
REC opinion
Further Information Favourable Opinion