Phase 1b, Trial to Evaluate Safety, of MB097 in Combination with Pembrolizumab in Melanoma Patients
Research type
Research Study
Full title
A Phase 1b, Randomized, Open-Label Trial to Evaluate Safety, Engraftment, and Initial Signs of Clinical Activity of MB097 in Combination with Pembrolizumab in Melanoma Patients with Primary Resistance to an Anti-PD-1-Containing Immunotherapy (MELODY-1)
IRAS ID
1009582
Contact name
Claire Birrell
Contact email
Sponsor organisation
Microbiotica Limited
Clinicaltrials.gov Identifier
Research summary
Melanoma is a serious type of skin cancer that can spread to other parts of the body when the disease has progressed. Immunotherapies are commonly used to treat melanoma, however new treatment options are still needed to extend the benefit to patients for which immunotherapies do not work (treatment-resistant patients).
Primary resistance to PD-1 inhibitors means never responding to the treatment and can impact how long patients with advanced melanoma survives. The gut microbiome, the community of bacteria in the gut, plays a crucial role in digesting food and protecting people from infections, but it also influences the immune system. In cancer patients, it appears to have a positive impact on response rates to immune checkpoint inhibitor therapies, such as anti PD-1 drugs. Microbiotica identified 9 key bacterial species strongly associated with a positive response to anti-PD-1-based immunotherapy which form the basis of MB097.The purpose of this study is to investigate the safety, tolerability, and potential efficacy of combining MB097 and an anti-PD1 drug called pembrolizumab in patients with cutaneous melanoma who have shown poor responses to immunotherapies.
This is a phase 1, first in human, randomised open label clinical trial with all patients receiving MB097 and Pembrolizumab for up to 6 months. Half of the participants will also receive vancomycin before starting the combination treatment of MB097 and pembrolizumab to determine whether it helps the bacterial strains in MB097 embed and grow in the gut. Each patient will be in the study for around 10 months, including a 3-month follow-up period. Participants seeming to benefit from the treatment at the end of the initial 6 month period may continue to receive pembrolizumab alone for up to approximately 18 months.
Approximately 18 different sites across 4 countries will be taking part, with an aim of 40 participants in total, split evenly across both cohorts.REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0288
Date of REC Opinion
20 May 2024
REC opinion
Further Information Favourable Opinion