The Clinical Study “Regoma 2”

I often receive inquiries from patients and caregivers asking me where to find active clinical trials. As you know, a chatbot is active on this website which is integrated with the clinical trials database that provides this type of answers but the list is also available in the article “Clinical studies on glioblastoma …“. By selecting the link at the bottom of the article you will get the updated list. This information is important because it is known that those who participate in clinical trials are followed better and on average obtain better results regardless of the outcome of the study.

This week I was intrigued by the announcement of the start of the “Regoma 2” clinical study at the IOV in Padua.

The announcement is interesting because it is a new therapeutic approach that immediately after surgery attacks glioblastoma in a combined way, i.e. through the use of Regorafenib, chemotherapy and radiotherapy without waiting for the disease to progress.

Many of the clinical trials in fact start as second-line therapy, i.e. the disease is expected to progress or in recurrence and generally when this happens the remaining time is shorter and the patient’s conditions are worse and so is the possibility of success. The therapy is therefore first-line and attacks the glioblastoma in a synergistic way, that is through a cocktail of treatments. Patients can be enrolled as early as this week and the requirements are that this is the first treatment, that is, immediately after surgery and that the patient is in good condition.

The study follows the previous “Regoma 1” which has shown to prolong the survival of patients with recurrence of glioblastoma using Regorafenib, a drug that works by reducing the vascularization and proliferation of cancer cells by inhibiting specific molecular alterations present in cancer cells, and was included in the Italian AIOM 2021 and American NCCN 2021 guidelines as a possible treatment for recurrent glioblastoma.

The Regoma 2 study, more specifically “Phase I study to evaluate the tolerability of the Regorafenib and Temozolomide combination with or without radiotherapy in patients with a new diagnosis of glioblastoma” is led by the IOV of Padua and also sees the participation of the Humanitas Institute of Milan and the University of Turin. This is a non-profit study for which 36 patients will initially be enrolled.

The hope is that the new treatment that plays ahead and proposes a new combination of drugs will be effective, preventing the disease from progressing and becoming more resistant to treatments.