A.R.B.O.R. BTC (Advancing Research and Breakthroughs for Oncology Regimens for Biliary Tract Cancer) or ARBOR BTC, is an open-label, multi-center, umbrella trial designed to evaluate multiple investigational treatment regiments in individuals with unresectable locally advanced and/or metastatic BTC. This Master Protocol is intended to provide an efficient and coordinated approach for research in the field of BTC, to allow for the concurrent evaluation of multiple investigational therapies, both targeted and aberration agnostic, in various stages of development. This strategy is meant to provide individuals affected by this deadly disease with the maximum potential to receive targeted treatment. ARBOR BTC allows investigational therapies to be evaluated using custom designs based on arm goals, from proof of concept to registration, including guideline updates. Investigational therapies may enter and/or complete evaluation within ARBOR BTC at different phases of study, depending on the intent of the given investigational arm.
ARBOR BTC CLINICAL LEADERSHIP TEAM
Mitesh Borad, MD (Mayo Clinic)
Milind Javle, MD (MD Anderson)
Tonios Bekaii-Saab, MD (Mayo Clinic)
Funda Meric-Bernstam, MD (MD Anderson)
Greg Lesinski, PhD, MPH (Emory)
Jennifer Knox, MD, MS (UHN – Princess Margaret)
Jim Harding, MD (Memorial Sloan Kettering)
Katie Kelley, MD (UCSF)
Rachna Shroff, MD, MS (University of Arizona)
Sameek Roychowdhury, MD, PhD (OSUMC)
Stacie Lindsey (CCF)
Juan Valle, MB ChB, MSc, FRCP (CCF)
Meredith Buxton, PhD, MPH (GCAR)
Robert Murray, MBA (GCAR)
ARBOR BTC KEY DESIGN ASPECTS
- Patient population: Progressive/recurrent unresectable locally advanced and/or metastatic BTC, including intrahepatic or extrahepatic CCA, GBC, and carcinoma of ampulla of Vater. Future considerations may include newly diagnosed BTC.
- Primary endpoint: Overall response rate or progression free survival (as appropriate for an investigational arm)
- Genetic sequencing methods per local institutional practice in Clinical Laboratory Improvement Amendments environment will be used to assign individuals to relevant treatment arm(s) based on identified aberrations
ARBOR BTC SCHEMA
- Lead by KOLs in the field in collaboration with the Cholangiocarcinoma Foundation and Global Coalition for Adaptive Research.
- Master Protocol provides more opportunities for individuals to be assigned to a targeted therapy.
- Design allows for multiple targeted agents to be studied within BTC simultaneously along with aberration agnostic agents.
- Investigational arms can be added at any time with the option to have a control arm based on current approved treatments.
Global Coalition for Adaptive Research (GCAR), a non-profit organization, in partnership with the Cholangiocarcinoma Foundation and in collaboration with the leading physicians in GI oncology, is sponsoring ARBOR BTC. GCAR’s core competencies include expertise in Master Protocols, and efficiencies in recruitment, cost reduction, and trial infrastructure development.
