Tumour-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

Titre officiel

Tumour-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

Sommaire:

Étude multicentrique internationale ouverte de phase II à cohortes multiples visant à évaluer l’innocuité et l’efficacité de traitements ciblés ou de l’immunothérapie administrés en monothérapie ou en association rationnelle et précise chez des participants atteints de tumeurs solides non résécables, avancées localement ou métastatiques, comportant des altérations génomiques oncogènes ou qui présentent un fardeau mutationnel tumoral élevé, d’après un test de séquençage de nouvelle génération. Les participants atteints de tumeurs solides seront traités avec un médicament ou un régime médicamenteux adapté aux résultats de ce test lors de la sélection. Les participants seront intégrés dans la cohorte appropriée, en fonction de leurs altérations génétiques. Le traitement sera sélectionné sur la base de l’oncogénotype pertinent, comprendra des critères d’inclusion ou d’exclusion propres à la cohorte et, sauf indication à l’effet contraire, sera poursuivi jusqu’à la progression de la maladie, la perte des bienfaits cliniques, l’apparition d’une toxicité inacceptable, la décision du participant ou du médecin d’arrêter le traitement ou le décès, selon la première éventualité.

Description de l'essai

Primary Outcome:

• All Cohorts: Independent Review Committee (IRC)-assessed objective response rate (ORR) based on confirmed objective response (OR) per Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST v1.1)

• All Cohorts: IRC-assessed duration of response (DOR) per RECIST v1.1
• All Cohorts: IRC-assessed clinical benefit rate (CBR) per RECIST v1.1
• All Cohorts: IRC-assessed progression free survival (PFS) per RECIST v1.1
• All Cohorts: Investigator (INV)-assessed ORR per RECIST v1.1
• All Cohorts: INV-assessed DOR per RECIST v1.1
• All Cohorts: INV-assessed CBR per RECIST v1.1
• All Cohorts: INV-assessed PFS per RECIST v1.1
• All Cohorts: IRC- and INV-assessed time to central nervous system (CNS) progression per RECIST v1.1
• All Cohorts: Overall Survival (OS)
• Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-ORR per Response Assessment in Neuro-Oncology (RANO)
• Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-DOR per RANO
• Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-CBR per RANO
• Cohorts A, B, C, D, I, J, K: IRC-assessed CNS-PFS per RANO
• Cohorts A, B, C, D, I, J, K: INV-assessed CNS-ORR per RANO
• Cohorts A, B, C, D, I, J, K: INV-assessed CNS-DOR per RANO
• Cohorts A, B, C, D, I, J, K: INV-assessed CNS-CBR per RANO
• Cohorts A, B, C, D, I, J, K: INV-assessed CNS-PFS per RANO
• Cohorts A, B, D, E, F, H, I, J, K: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC)
• Cohorts A, B, D, E, F, H, I, J, KIRC-assessed DOR per INRC
• Cohorts A, B, D, E, F, H, I, J, K: IRC-assessed CBR per INRC
• Cohorts A, B, D, E, F, H, I, J, K: IRC-assessed PFS per INRC
• Cohorts A, B, D, E, F, H, I, J, K: INV-assessed ORR per INRC
• Cohorts A, B, D, E, F, H, I, J, K: INV-assessed DOR per INRC
• Cohorts A, B, D, E, F, H, I, J, K: INV-assessed CBR per INRC
• Cohorts A, B, D, E, F, H, I, J, K: INV-assessed PFS per INRC
• All Cohorts: IRC-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive circulating tumour DNA (ctDNA) by blood-based next-generation sequencing (NGS) assay
• All Cohorts: IRC-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
• All Cohorts: IRC-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
• All Cohorts: IRC-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
• All Cohorts: INV-assessed ORR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
• All Cohorts: INV-assessed DOR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
• All Cohorts: INV-assessed CBR per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
• All Cohorts: INV-assessed PFS per RECIST v1.1 in participants with alteration/biomarker-positive ctDNA by blood-based NGS assay
• Cohorts A, B, C, D, I, J, K: IRC-assessed intracranial (IC)-ORR per RECIST v1.1
• Cohorts A, B, C, D, I, J, K: IRC-assessed IC-DOR per RECIST v1.1
• Cohorts A, B, C, D, I, J, K: IRC-assessed IC-CBR per RECIST v1.1
• Cohorts A, B, C, D, I, J, K: IRC-assessed IC-PFS rate per RECIST v1.1
• Cohorts A, B, C, D, I, J, K: INV-assessed IC-ORR per RECIST v1.1
• Cohorts A, B, C, D, I, J, K: INV-assessed IC-DOR per RECIST v1.1
• Cohorts A, B, C, D, I, J, K: INV-assessed IC-CBR per RECIST v1.1
• Cohorts A, B, C, D, I, J, K: INV-assessed IC-PFS rate per RECIST v1.1
• All Cohorts: Percentage of participants with confirmed deterioration as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
• All Cohorts: Change from Baseline in the EORTC-QLQ-C30 total score
• All Cohorts: Percentage of participants with a clinical meaningful change on the Global Health Status, Physical Functioning, and Role Functioning scores from the EORTC QLQ-C30
• All Cohorts: Time to confirmed symptom onset or worsening from tumour-related symptom scores from the EORTC QLQ-C30 and EORTC Item Library
• All Cohorts: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Cohorts A, B: Plasma concentration of entrectinib at specified timepoints
• Cohort C: Plasma concentration of alectinib at specified timepoints
• Cohort D: Plasma concentration of atezolizumab at specified timepoints
• Cohort E: Plasma concentration of ipatasertib at specified timepoints
• Cohort F: Serum concentration of trastuzumab emtansine at specified timepoints
• Cohort G: Plasma concentration of idasanutlin at specified timepoint
• Cohort H: Plasma concentration of GDC-0077 at specified timepoints
• Cohorts D, F: Percentage of participants with anti-drug antibodies (ADA)

Voir cet essai sur ClinicalTrials.gov