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
2262 - Real world experience of Nivolumab therapy in Metastatic Renal Cancer patients: a 3 year multi-centre review
Presenter: Joanna Hack
Session: Poster Display session 3
Resources:
Abstract
4441 - “A pilot study of tremelimumab (treme) with or without cryoablation (cryo) in patients (pts) in metastatic renal cell carcinoma (mRCC).”
Presenter: Matthew Campbell
Session: Poster Display session 3
Resources:
Abstract
2613 - Lenvatinib (Len) alone or in combination with Everolimus (Eve) in heavily pretreated patients (pts) with metastatic renal cell carcinoma (mRCC) after immune checkpoint inhibitors (ICI) and VEGFR-targeted therapies: A single-institution experience
Presenter: Andrew Wiele
Session: Poster Display session 3
Resources:
Abstract
3249 - Weight loss is an underestimated adverse event with cabozantinib in patients with metastastic renal cell carcinoma (mRCC).
Presenter: Emeline Colomba
Session: Poster Display session 3
Resources:
Abstract
2405 - Impact of corticosteroids on nivolumab activity in metastatic clear cell renal cell carcinoma.
Presenter: Felix Lefort
Session: Poster Display session 3
Resources:
Abstract
4020 - Skeletal muscle loss as an adverse event during Cabozantinib treatment in patients with metastatic renal cell carcinoma
Presenter: Carolina Alves Costa Silva
Session: Poster Display session 3
Resources:
Abstract
2407 - Long term relative survival (RS) in patients with primary metastatic kidney cancer (primary mRCC): an analysis of 2,167 patients from the Austrian National Cancer Registry (ANCR).
Presenter: Monika Hackl
Session: Poster Display session 3
Resources:
Abstract
2470 - Advanced renal cell carcinoma: first results from the prospective research platform CARAT for patients with mRCC in Germany
Presenter: Peter Goebell
Session: Poster Display session 3
Resources:
Abstract
1533 - Are immune checkpoint inhibitors a valid option for papillary Renal Cell Carcinoma? Transcriptomic characterization of the immune infiltrate
Presenter: Manon De Vries-brilland
Session: Poster Display session 3
Resources:
Abstract
3367 - Treatment-Free Survival, With and Without Toxicity, as a Novel Outcome Applied to Immuno-Oncology Agents in Advanced Renal Cell Carcinoma
Presenter: Meredith Regan
Session: Poster Display session 3
Resources:
Abstract