HBI-8000-303: HBI-8000 with Nivolumab v Placebo with Nivolumab
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind Phase 3 Study of HBI-8000 Combined with Nivolumab versus Placebo with Nivolumab in Patients with Unresectable or Metastatic Melanoma Not Previously Treated with PD-1 or PD-L1 Inhibitors
IRAS ID
305393
Contact name
Ewan Brown
Contact email
Sponsor organisation
HUYABIO International LLC
Eudract number
2019-002521-30
Clinicaltrials.gov Identifier
139784, IND
Duration of Study in the UK
3 years, 6 months, 7 days
Research summary
Our research has shown that HBI-8000, an HDAC inhibitor and experimental drug, has the potential to increase the effectiveness of immunotherapeutic drugs, such as nivolumab, in treating advanced melanoma. The purpose of this study is to determine if HBI-8000, will help nivolumab (a standard of care treatment for melanoma) slow down the growth of melanoma, shrink the size of tumour(s), or extend life.
Approximately 480 participants will take part. Every participant in this randomised study will be treated with nivolumab. One group will be treated with nivolumab and HBI-8000 and one group will be treated with nivolumab and placebo (a tablet that looks like HBI-8000 but contains no active ingredient). Adults with new, progressive brain metastasis will be treated with a combination of HBI-8000 and nivolumab.
The study will include a Screening period (up to 28 days), up to 24 months of treatment of HBI-8000 or Placebo in combination with nivolumab until disease progression, withdrawal of consent or unacceptable toxicity occurs. In addition, at the end of treatment with the study drug (HBI-8000 or Placebo) with nivolumab, safety visits will be included. Follow-up telephone calls/ emails for tumour status and survival information will be collected post treatment with the study drugs. The study is projected to complete in approximately 50 months; however, participants enrolled early during the study enrolment period may have a longer participation.
REC name
London - Fulham Research Ethics Committee
REC reference
22/LO/0123
Date of REC Opinion
14 Apr 2022
REC opinion
Further Information Favourable Opinion