Abstract 2655
Background
Previous studies reveal that key oncogenic pathways are shared across various human cancer types, and molecularly targeted therapies show clinical efficacy, influenced by predictive biomarkers rather than by tumor histologic types. These results raised the concept of biomarker-driven therapy that enables personalized cancer treatment regardless of tumor location and origin. We hereby introduce the designs and goals of the K-BASKET trial (Korea-biomarker-driven multi-arm drug-screening, knowledge and evidence-generating targeted trial), enabling to match the right drug to right target like NCI-MATCH trial.
Trial design
This is a proof-of-concept phase II multiple basket trial to test the clinical significance of matched targeted therapies with comprehensive biomarker profiling. The patients with refractory metastatic or unresectable cancer of various origins will be screened for molecular biomarkers by next-generation sequencing, immunohistochemical staining, and in situ hybridization. Those who have cancer with druggable biomarkers will be treated with matched targeted agents. Three treatment arms for the second step are the followings; 1) Patients with MET amplification or exon 14 skipping MET mutation will be assigned to the TAS-115 arm, a novel multikinase inhibitor. 2) Patients with activating PIK3CA or AKT mutations will be assigned to the TAS-117 arm, a novel selective AKT inhibitor. 3) The remaining patients will be screened for PD-L1/MSI/EBV status and those with positive PD-L1/MSI/EBV results or PolD/PolE mutations will be treated with PD-L1 monoclonal antibody. The clinical efficacy and safety of the targeted therapy, as well as the feasibility of molecular profiling and drug matching, will be tested. This study is particularly relevant because: 1) it will identify new indications and predictive biomarkers of targeted therapies in common cancer types in Asian; 2) it is one of the earliest basket trials in tumor immunotherapy and molecular profiling. We anticipate that this trial will provide valuable information on biomarker-driven therapy in clinical practices of personalized treatment.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Yonsei University.
Funding
National R&D Program for Cancer Control, Ministry of Health and Welfare, Republic of Korea (HA16C0018).
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
2743 - The Impact of Targeted Therapies and Immunotherapy in Melanoma Brain Metastases: a Systematic Review and Meta-Analysis
Presenter: Mario Mandala
Session: Poster Display session 3
Resources:
Abstract
5479 - Intracranial Anti-Tumor Activity in Melanoma Brain Metastases with Encorafenib Plus Binimetinib: A Multicenter, Retrospective Analysis
Presenter: Jose Lutzky
Session: Poster Display session 3
Resources:
Abstract
3560 - Outcomes of Patients with Melanoma Brain Metastases (MBM) Treated with Standard of Care Therapy After Being Excluded from MBM-Specific Clinical Trials
Presenter: Kourtney Holbrook
Session: Poster Display session 3
Resources:
Abstract
3175 - The analysis of current treatment outcomes in melanoma patients with brain metastases
Presenter: Joanna Placzke
Session: Poster Display session 3
Resources:
Abstract
4550 - A multivariate model to define prognostic groups among patients with melanoma brain metastases: a 10-year retrospective cohort study
Presenter: Giacomo Pelizzari
Session: Poster Display session 3
Resources:
Abstract
4191 - The immune landscape of melanoma significantly influences survival in patients with highly mutated tumors.
Presenter: Robert Ferguson
Session: Poster Display session 3
Resources:
Abstract
1625 - Final Results from Phase II of Combination with Canerpaturev (formerly HF10), an Oncolytic Viral Immunotherapy, and Ipilimumab in Unresectable or Metastatic Melanoma in 2nd-or later line treatment
Presenter: Kenji Yokota
Session: Poster Display session 3
Resources:
Abstract
5346 - Evaluating polygenic risk score prediction model for melanoma prognosis
Presenter: Miriam Potrony
Session: Poster Display session 3
Resources:
Abstract
5477 - Impact of sarcopenia in patients with metastatic melanoma treated with immunotherapy
Presenter: Maria Grazia Vitale
Session: Poster Display session 3
Resources:
Abstract
3469 - Ancillary evaluation of systemic immune antitumor response (SIAR) and tumor growth rate (TGR) of patients (pts) with metastatic melanoma (MM) treated with radiotherapy (RT) combined with ipilimumab (ipi) in the phase 1 study Mel-Ipi-Rx.
Presenter: Celine Boutros
Session: Poster Display session 3
Resources:
Abstract