Phase 1/1b Open label Study of MK-4621/JetPEI by IT Injection
Research type
Research Study
Full title
A Phase 1/1b, Open-label Clinical Study of Intratumoral/Intralesional Administration of MK-4621/JetPEI as Monotherapy or in Combination With Pembrolizumab (MK-3475) in Participants with Advanced/Metastatic or Recurrent Solid Tumors
IRAS ID
249504
Contact name
Paul Robinson
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-000845-37
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
In the past few years, significant progress has been made in the field of immunotherapy (helping the body’s immune system) to treat cancer. However, the majority of advanced cancer patients still do not respond to immunotherapy due to, for example, cancers developing resistance against the immune system.
MK-4621 is a newly developed double-stranded 5’-triphosphate RNA immunotherapy drug that binds to and activates the RIG-I protein, a receptor molecule found in almost every type of cell that results in the induction of immune response. Preclinical experiments have found that RIG-I activation in tumour cells can trigger cell death but has little effect in healthy cells.
Programmed cell death 1 (PD1) is a protein present on the surface of immune cells which fight cancer. When programmed cell death ligands 1 and 2 (PDL1 and PDL2) proteins found on cancer cells bind to PD1 on immune cells, the immune cells become exhausted/die thus stopping them from attacking the cancer. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing immune attack on cancers.
Preclinical studies have shown that MK-4621 can have increased antitumour activity when administered in combination with PD-1 inhibitors like pembrolizumab.
This open-label phase I/Ib study will investigate the safety and tolerability, as well as establish a recommended dose for subsequent Phase II studies, of MK-4621 when administered on its own and also in combination with pembrolizumab. Approximately 72 male/female participants aged 18 years or over with advanced/metastatic or recurrent solid tumours will be enrolled and assigned non-randomly to one of the three groups of the trial. These participants will have received, or been intolerant to, previous treatments. The trial will last approximately 2.5 years.
The study is sponsored by Merck Sharp & Dohme Limited. It will take place at a single study centre in the UK.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
18/SC/0439
Date of REC Opinion
29 Aug 2018
REC opinion
Favourable Opinion