TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIA

F. Hoffmann-La Roche Ltd0 sites920 target enrollmentNovember 9, 2020

Conditionsocally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are TMB-high as identified by a validated NGS assay MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsTecentriq

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ocally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are TMB-high as identified by a validated NGS assay
Sponsor: F. Hoffmann-La Roche Ltd
Enrollment: 920
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 9, 2020

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

F. Hoffmann-La Roche Ltd

Eligibility Criteria

Inclusion Criteria

•? Histologically or cytologically confirmed diagnosis of advanced and unresectable or metastatic solid malignancy
•? Measurable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1\.1 (RECIST v1\.1\), Response Assessment in Neuro\-Oncology (RANO) criteria, or International Neuroblastoma Response Criteria (INRC)
•? Performance status as follows: Participants aged \>\= 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status 0\-2; Participants aged 16 to \< 18 years: Karnofsky score \>\= 50%; Participants aged \< 16 years: Lansky score \>\= 50%
•? For participants aged \>\= 18 and \<18 years: adequate hematologic and end\-organ function
•? Disease progression on prior treatment, or previously untreated disease with no available acceptable treatment
•? Adequate recovery from most recent systemic or local treatment for cancer
•? Life expectancy \>\= 8 weeks
•? Ability to comply with the study protocol, in the investigator's judgment
•? For female participants of childbearing potential: Negative serum pregnancy test \<\= 7 days prior to initiating study treatment; agreement to remain abstinent or use single or combined contraception methods that result in a failure rate of \< 1% per year for the period defined in the cohort\-specific inclusion criteria; and agreement to refrain from donating eggs during the same period
•o Stricter cohort\-specific contraception requirements may be included in the cohort\-specific appendices

Exclusion Criteria

•? Current participation or enrollment in another therapeutic clinical trial
•? Any anticancer treatment within 2 weeks prior to start of study treatment (Please refer to the cohort\-specific eligibility criteria for requirements on enrollment, if applicable)
•? Whole brain radiotherapy within 14 days prior to start of study treatment
•? Stereotactic radiosurgery within 7 days prior to start of study treatment
•? Pregnant or breastfeeding, or intending to become pregnant during the study
•? History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study or confounds the ability to interpret data from the study
•? Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment
•? Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or higher), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
•? History of another active cancer within 5 years prior to screening that may interfere with the determination of safety or efficacy of study treatment with respect to the qualifying solid tumor malignancy
•? In addition to the general exclusion criteria above, in order to be enrolled in a treatment cohort of the study, participants must not meet any of the cohort\-specific exclusion criteria