BNT111-01 _Phase II trial with BNT111 and cemiplimab_ Melanoma
Research type
Research Study
Full title
An open-label, randomized Phase II trial with BNT111 and cemiplimab in combination or as single agents in patients with anti-PD1-refractory/relapsed, unresectable Stage III or IV melanoma
IRAS ID
286776
Contact name
Toby Talbot
Contact email
Sponsor organisation
BioNTech SE
Eudract number
2020-002195-12
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND, 25176
Duration of Study in the UK
3 years, 7 months, 0 days
Research summary
This is an open-label, randomised, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of the study drugs BNT111 + cemiplimab in anti-PD1- refractory/relapsed patients with unresectable Stage III or IV melanoma.
Patients will be randomised in a 2:1:1 ratio into 3 Arms:
Arm 1: BNT111 + cemiplimab
Arm 2: BNT111 monotherapy
Arm 3: cemiplimab monotherapy
Patients in Arms 2 and 3, who experience centrally verified disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent.
BNT111 will be given as intravenous (IV) injection at a dose of 50 µg total RNA for the first dose and subsequently at a dose of 100 µg total RNA. BNT111 will be given once weekly for the first 6 weeks, followed by treatments once every 3 weeks (±3 d). Cemiplimab will be given once every 3 weeks (±3 d) as IV infusion at a dose of 350 mg. Cemiplimab will be administered after administration of BNT111 with at least 30 min interval. Treatment duration is up to 24 months and will continue until unacceptable toxicity, withdrawal of consent, discontinuation due to investigator’s decision or (confirmed) disease progression. Treatment with cemiplimab and/or BNT111 may be continued through initial radiological disease progression until symptomatic disease progression or unacceptable toxicity.
The trial will take place in about 60 trial sites, in up to 15 countries. 120 patients will be randomised.
This trial is designed to address the high unmet medical need of patients with unresectable Stage III or IV melanoma who failed anti-PD1 drugs. Due to the mechanisms of actions of BNT111 and cemiplimab, it is expected that the combination of the two agents will have a synergistic anti-tumour effect in patients that have failed previous anti-PD1 therapy.REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0093
Date of REC Opinion
13 Jul 2021
REC opinion
Further Information Favourable Opinion