The Fast Real-time Assessment of Combination Therapies in Immuno-ONcology (FRACTION) program: innovative, high-throughput clinical screening of immunotherapies
| Autor: | Katy L. Simonsen, Adriana Comprelli, Paula M. Fracasso, Steven H. Bernstein, Cassidy James, Timothy P. Reilly, Megan Wind-Rotolo, Manish Gupta |
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| Rok vydání: | 2018 |
| Předmět: |
Oncology
Male Cancer Research medicine.medical_specialty Ipilimumab 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Humans 030212 general & internal medicine Lung cancer Survival rate business.industry Clinical study design Cancer medicine.disease Combined Modality Therapy Tolerability 030220 oncology & carcinogenesis Biomarker (medicine) Female Immunotherapy Nivolumab business medicine.drug |
| Zdroj: | European journal of cancer (Oxford, England : 1990). 103 |
| ISSN: | 1879-0852 |
| Popis: | Background The unprecedented success of immuno-oncology (I-O) agents targeting the cytotoxic T lymphocyte–associated antigen 4 and programmed death-1/programmed death-ligand 1 pathways has stimulated the rapid development of other I-O agents against novel immune targets. Bristol-Myers Squibb has designed a novel phase II platform trial, the Fast Real-time Assessment of Combination Therapies in Immuno-ONcology (FRACTION) Program, to efficiently identify promising combinations for patients with specific malignancies. The concept and study design of the FRACTION Program—currently ongoing in patients with advanced non-small-cell lung cancer (FRACTION-Lung), gastric cancer (FRACTION-Gastric Cancer) and renal cell carcinoma (FRACTION-RCC)—are described. Methods The FRACTION Program comprises open-label, phase II studies that use adaptive randomisation designs with rolling combination regimens. Master Protocols provide the overall study design framework, whereas Sub-Protocols introduced over time provide details on specific I-O combination therapies to which patients may be randomised. In a Master Protocol, patients are enrolled into different Study Tracks based on characteristics such as prior I-O therapy experience. Patients who progress may be rerandomised to other combination regimens from any ongoing Sub-Protocol. Primary objectives are to assess objective response rate, median duration of response and progression-free survival rate at 24 weeks; the secondary objective is to investigate safety and tolerability. Biomarker collection before and on treatment will facilitate identification of patient subsets who benefit most from each therapy. Conclusions The FRACTION Program allows for the evaluation of multiple I-O combinations through individual studies for specific tumours using an adaptive trial design and continuous enrolment. |
| Databáze: | OpenAIRE |
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