FMPV-1 in Addition to Pembrolizumab for the Treatment of Metastatic Colorectal Cancer
Research type
Research Study
Full title
A Phase 2 Clinical Study of FMPV-1/GM-CSF in Addition to Standard of Care (SoC) Pembrolizumab in Patients with Metastatic MSI-H Colorectal Tumours with Particular Reference to TGFR2 Frameshift Mutation
IRAS ID
1006952
Contact name
Mark Saunders
Contact email
Sponsor organisation
Hubro Therapeutics AS
Eudract number
2022-002026-26
Research summary
The purpose of the study is to assess the effects of an experimental therapy called FMPV-1/GM-CSF. People aged 18 years or more who have metastatic microsatellite instability-high (MSI-H) colorectal cancer, who are eligible to be treated with an immunotherapy called pembrolizumab per routine clinical practice, are being asked to participate in this research study. The study doctors will assess the effects that FMPV-1/GM-CSF has on people with colorectal cancer, to determine how safe it is to give in addition to the pembrolizumab, and to see how many participants show an improvement in their disease (shrinkage of tumours or slowing the progression of the cancer). The therapy being tested is FMPV-1/GM-CSF, an experimental cancer vaccine. The vaccine has been designed to treat certain types of cancer commonly linked to a molecular problem called Microsatellite instability (MSI). The MSI causes DNA to mutate so it is less effective at repairing itself. The presence of mutated DNA can then lead to diseases such as cancer. Frameshift mutations, such as that of TGFbR2 occur in the MSI-high (MSI-H) cancer type. As many types of cancer caused by MSI have similar mutated proteins, parts of these proteins can be used to make a vaccine and to train the immune system to fight these cells. Participants will be asked to read and sign a consent form before any study procedures are done, and will enter a screening period lasting up to 28 days to see if study participation is appropriate. The treatment and follow-up period will last up to 101 weeks. FMPV-1/GM CSF will be given on Days 1, 8, 15 and 29, then every 3 weeks until Week 13, then every 6 weeks until Week 25, and then every 12 weeks until Week 97. Participants will have a follow-up visit about 4 weeks after the final dose of FMPV-1/GM-CSF. Therefore, participants will be in the study for a total of 101 weeks, which will include approximately 22 clinic visits.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0022
Date of REC Opinion
25 Aug 2023
REC opinion
Further Information Favourable Opinion