Glioblastoma is a rare type of brain cancer. Sadly, it is the most aggressive form. The median life expectancy for the disease is between 11 and 15 months and that is with chemotherapy, radiation, and surgical treatment. Most commonly, glioblastoma affects males who are over the age of 60, but anyone can face the diagnosis.
A new clinical trial for glioblastoma has officially enrolled the first patient. It will actually be the worlds largest ever clinical trial for the disease. It is called the GBMAGILE Trial which stands for Glioblastoma Adaptive Global Innovative Learning Environment.
The first patient was enrolled at the Henry Ford Cancer Institute.
The GBM Knowledge Network is a group of 130 experts in glioblastoma. They come from all over the world and include clinicians, pathologists, as well as industry leaders and patient advocates.
This group is who first conceived the idea of the GBMAGILE trial back in 2015. Now, it is in full swing just 4 years later.
The Phase 2 portion will examine the efficacy and the safety of various therapies. The Phase 3 portion will then confirm the results.
The trial is being sponsored by the Global Coalition for Adaptive Research or GCAR. This coalition includes some of the top scientists globally. It aims to facilitate the open exchange of knowledge and ideas, fostering a collaborative approach to rare disease research. The unique trial design of GBMAGILE fits perfectly with their philosophy.
Traditional clinical trials investigate only one therapy, comparing a new treatment to the standard of care for a particular disease. This trial is unique because it is investigating numerous therapies at the same time. Ultimately, this means the research process is accelerated and potentially more therapies could be approved faster.
“A move away from the traditional, one-size-fits-all approach to clinical trials – a major step forward for precision medicine.”
One of the best parts about this unique trial design is that it utilizes adaptive randomization. Essentially, this means that as the trial progresses and the researchers better understand which participants may benefit from a certain therapy, they group them into subsets who should receive that particular treatment. This allows the patients to receive the treatments that have the greatest chance of benefiting them faster. Additionally, it is a more cost effective mechanism.
Considering the fact that traditional trials cannot be modified at all once they are started, this unique design is incredibly beneficial for patients.
“We are launching an era of unprecedented collaboration and advancement.”
Researchers believe that there is great progress that can be made in glioblastoma research. Hopefully, this new, uniquely designed trial will help to accelerate this progress and produce tangible outcomes.
The researchers hope to bring this trial to international sites by next year.
You can read more about this clinical trial and how it was designed here.