NEW YORK – TargetCancer Foundation said on Wednesday that it initiated the TCF-001 TRACK study, a prospective clinical trial that will enroll 400 patients with rare cancers such as cholangiosarcoma or cancers of unknown primary.
TargetCancer Foundation is the study's sponsor, and Bayer is also a founding supporter. Roche subsidiary Foundation Medicine, which markets tissue and blood-based next-generation sequencing panels for guiding cancer treatment, is also a collaborator.
The University of California, San Diego and MD Anderson Cancer Center are the enrollment sites for the study. However, since the aim of this effort is to enroll rare cancer patients in geographic areas that often don't have access to clinical trials, patients can also enroll in TRACK remotely with TargetCancer Foundation without having to travel to one of the main sites. Patients can remotely consent to partake in the study and will be able to access genomic information and tailored treatment recommendations through their local treating physician.
Foundation Medicine will perform comprehensive genomic profiling using both its FoundationOne CDx test for solid tissue samples and FoundationOne Liquid test for blood samples at baseline when patients first enroll in the study, as well as at multiple timepoints over the study period.
Patients' data will be reviewed by a virtual molecular tumor board that includes leading oncologists, pathologists, surgeons, and other experts, who will recommend a genomically directed treatment option for each patient in the study. The tumor board may recommend on-label, off-label, or investigational treatments in clinical trials. The patient's ultimate treatment journey and responses will be prospectively tracked for at least one year, allowing researchers to link molecularly informed treatments to specific outcomes.
The TRACK study will also generate genomic data that improves understanding of rare cancers.
"While unprecedented advances throughout the field continue, lack of data and insights sometimes stymie progress for treating rare cancers," Razelle Kurzrock, principal investigator of TRACK and director of the Center for Personalized Cancer Therapy at UC San Diego, said in a statement. "With TRACK we have the opportunity to advance rare cancer research and treatment through this exciting new partnership with TargetCancer Foundation and Foundation Medicine."
The co-principal investigators of TRACK are Vivek Subbiah from MD Anderson Cancer Center, James Cleary from Dana-Farber Cancer Institute, and Roman Groisberg from Rutgers Cancer Institute of New Jersey.