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:

TAPISTRY is a Phase II, global, multicentre, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumours determined to harbor specific oncogenic genomic alterations or who are tumour mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumours will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.

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: IRC-assessed CNS-ORR per Response Assessment in Neuro-Oncology (RANO)
• Cohorts A, B, C, D: IRC-assessed CNS-DOR per RANO
• Cohorts A, B, C, D: IRC-assessed CNS-CBR per RANO
• Cohorts A, B, C, D: IRC-assessed CNS-PFS per RANO
• Cohorts A, B, C, D: INV-assessed CNS-ORR per RANO
• Cohorts A, B, C, D: INV-assessed CNS-DOR per RANO
• Cohorts A, B, C, D: INV-assessed CNS-CBR per RANO
• Cohorts A, B, C, D: INV-assessed CNS-PFS per RANO
• Cohorts A, B, D, E, F, G, H: IRC-assessed ORR per International Neuroblastoma Response Criteria (INRC)
• Cohorts A, B, D, E, F, G, H: IRC-assessed DOR per INRC
• Cohorts A, B, D, E, F, G, H: IRC-assessed CBR per INRC
• Cohorts A, B, D, E, F, G, H: IRC-assessed PFS per INRC
• Cohorts A, B, D, E, F, G, H: INV-assessed ORR per INRC
• Cohorts A, B, D, E, F, G, H: INV-assessed DOR per INRC
• Cohorts A, B, D, E, F, G, H: INV-assessed CBR per INRC
• Cohorts A, B, D, E, F, G, H: 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: IRC-assessed intracranial (IC)-ORR per RECIST v1.1
• Cohorts A, B, C, D: IRC-assessed IC-DOR per RECIST v1.1
• Cohorts A, B, C, D: IRC-assessed IC-CBR per RECIST v1.1
• Cohorts A, B, C, D: IRC-assessed IC-PFS rate per RECIST v1.1
• Cohorts A, B, C, D: INV-assessed IC-ORR per RECIST v1.1
• Cohorts A, B, C, D: INV-assessed IC-DOR per RECIST v1.1
• Cohorts A, B, C, D: INV-assessed IC-CBR per RECIST v1.1
• Cohorts A, B, C, D: 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)

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