Clinicians at Massachusetts General Hospital are now enrolling patients in a new Phase 2 clinical trial sponsored by biotechnology company Bavarian Nordic that will determine whether a cancer treatment vaccine in combination with radiation can cause tumors to shrink in patients with advanced chordoma. This is the first of several medical centers across the United States to begin enrolling patients on this trial.
Rationale for this trial
The vaccine, called BN-Brachyury, prompts the immune system to attack and kill cells that contain a protein called brachyury, identified as the key driver of chordoma. All chordoma cells express brachyury, but brachyury is not present in normal, healthy cells. Therefore, generating an immune response against cells that express brachyury could enable the immune system to destroy chordoma cells while sparing normal cells.
Additionally, radiation has been shown in other cancers to enhance the effectiveness of immune therapy by helping to stimulate a heightened immune response by making tumor cells more sensitive to being killed by the immune system. This understanding provided the basis for combining radiation with the vaccine.
BN-brachyury is a prime-boost vaccine, meaning that the first vaccine doses “prime” the immune system response, and the following doses boost that response and make it stronger.
In a previous Phase 1 trial, it was given safely without serious adverse events. Therefore, the Chordoma Foundation’s Medical and Scientific Advisory Boards endorsed this Phase 2 trial concept as relevant and well-justified for the Chordoma Foundation patient community.
Who can participate
This trial is designed specifically for chordoma patients who have locally advanced or metastatic tumors and are planning to have radiation. To be eligible to enroll in this study, you must:
- Have a diagnosis of chordoma
- Have advanced or metastatic disease that cannot be cured by surgery
- Be able to receive the biologic equivalent of at least 8 Gy in a single fraction of radiation to one tumor site (you must talk with your radiation oncologist about this)
- Be willing and able to travel to your enrolling study site for all treatment and follow-up visits (a list of sites is available on clinicaltrials.gov)