NEW YORK – Bayer on Wednesday announced that the first patient has been enrolled in the Target Rare Cancer Knowledge (TRACK) study.
The study, which Bayer is supporting financially, is sponsored by the TargetCancer Foundation in collaboration with Foundation Medicine and academic investigators. The goal is to match roughly 400 patients with rare cancers, defined as cancers that occur in fewer than six in 100,000 people per year, and to personalized treatments based on the molecular alterations identified in their cancers via next-generation sequencing.
Patients enrolled in the trial who receive molecularly informed personalized treatments will be followed for a period of at least one year so that investigators can assess their outcomes and responses to matched drugs. The data gleaned from sequencing these patients will also allow investigators to develop a better understanding of the underlying genomics of rare cancers, including cholangiocarcinoma and cancers of unknown primary origin, among others.
The TRACK study, which plans to enroll 100 patients each with cholangiocarcinoma and cancers of unknown primary origin, and 200 patients with other types of rare cancers, has a decentralized design that allows patients to consent and participate remotely, which in turn limits the need to travel long distances to study sites, a factor that often hinders enrollment. Based on the results from Foundation Medicine's FoundationOne CDx and FoundationOne Liquid NGS tests, which are provided to TRACK participants free of cost, a virtual molecular tumor board will recommend matched treatments. Ultimately, the patients and their treating physicians at local cancer centers will decide whether to follow the virtual molecular tumor board's recommendations.
"People with rare cancers deserve better informed, individualized and targeted treatment choices, and we look forward to having these patients enrolled in TRACK," Jim Palma, TargetCancer Foundation's executive director, said in a statement. "We are making significant strides in shifting clinical practice norms by challenging traditional methods of clinical trial enrollment and introducing virtual care into the treatment continuum, and we are grateful for Bayer’s longstanding support of these efforts."