MICROCARE, the phase 3 trial evaluating the gut microbiome protector DAV132 in patients with hematologic malignancies, is making sure all sites are able to start including patients. On September 23rd, the second Investigator Meeting took place.
The aim of the Investigator Meetings, held on May 20th and September 23rd, was to train the staff from participating sites on patient enrolment. During the virtual meetings, Da Volterra had the opportunity to explain the benefit of protecting microbiota for better patient outcome. Da Volterra also discussed topics such as the key figures, the study rationale, a protocol overview, timeline and enrolment goals, study visits and procedures, and microbiology testing.
Currently there are 23 activated sites in 11 countries. From COMBACTE’s clinical network, sites in Austria, Czech Republic, France, Hungary, Italy, Poland and Spain are enrolling patients. The first patient was enrolled in July 2021. Da Volterra received regulatory approvals for the United Kingdom this week, sites in these countries can now join the clinical trial. Approvals for Germany will be obtained shortly. Site selection in the United States is in progress as well, and the team is implementing booster activities with Medical Science Liaison to visit sites.
LAB-Net is also involved in the MICROCARE trial, as the study’s central lab is based at the University of Antwerp. Their central lab activities will increase and diversify with the receiving of an increasing number of samples, by programming the first repatriation of stools, and their analysis, while continuing initial supplies of kits and their renewal.
Since July 2020, Da Volterra and COMBACTE-NET are collaborating in starting up the MICROCARE trial. MICROCARE is a Phase 3, multicenter, randomized, placebo-controlled, parallel-arm clinical trial performed across Europe and North America. The trial aims to demonstrate the efficacy of DAV132, a microbiota-protective therapy in preventing the occurrence of Clostridioides difficile infection (CDI). The trial will enroll patients with newly diagnosed Acute Myeloid Leukemia (AML) or high risk Myelodysplatic Syndrome treated with intensive chemotherapy. The study will determine whether the protection of the intestinal microbiota reduces the incidence of CDI, the colonization by multidrug-resistant bacteria, bacteremia, acute graft-versus-host disease (GvHD), and improves the long-term survival of transplanted patients. Onco-hematological sites are selected for this trial, which have to work to the inclusion target of 900 patients.