AGEN1181-Phase 2 Study of Botensilimab (AGEN1181) in Advanced Melanoma
Research type
Research Study
Full title
A MULTICOHORT, OPEN LABEL, PHASE 2 STUDY OF BOTENSILIMAB (AGEN1181) FOR TREATMENT OF ADVANCED MELANOMA REFRACTORY TO PRIOR CHECKPOINT INHIBITOR THERAPY
IRAS ID
1005737
Contact name
Cristina D'Angeli
Contact email
Sponsor organisation
Agenus, Inc.
Clinicaltrials.gov Identifier
Research summary
Melanoma is a lethal form of skin cancer whose incidence has been rising rapidly over recent decades. Treatment for advanced melanoma has evolved rapidly in recent years with the development of immunotherapy (IO) and targeted therapy. Checkpoint inhibition, a type of IO, has become a cornerstone of the melanoma treatment armamentarium. Previous studies have demonstrated that checkpoint inhibition therapy is an efficacious first-line treatment for many patients with metastatic melanoma, however approximately 50% fail to achieve an objective response and of those who do respond many subsequently relapse (i.e., secondary resistance). Agenus Inc., has developed an experimental medication, BOTENSILIMAB, to treat patients (≥ 18 years of age) with advanced skin cancer (melanoma) previously treated with checkpoint inhibitor therapy. Therefore, the primary purpose of this study is to evaluate the safety and clinical efficacy of the BOTENSILIMAB monotherapy to treat advanced cutaneous melanoma. Participants will be on study for a maximum of 2 years and will have to visit one of the NHS selected sites for the study visits. After screening, participants will receive a maximum of 4 doses of BOTENSILIMAB (one every three weeks). Once the treatment ends, safety/efficacy and survival follow-up visits will be arranged for the remain time.
REC name
HSC REC A
REC reference
22/NI/0126
Date of REC Opinion
27 Sep 2022
REC opinion
Further Information Favourable Opinion