To Study Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY)
Research type
Research Study
Full title
TUMOR-AGNOSTIC PRECISION IMMUNOONCOLOGY AND SOMATIC TARGETING RATIONAL FOR YOU (TAPISTRY) PHASE II PLATFORM TRIAL
IRAS ID
1003534
Contact name
Dr Matthew Krebs
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2020-001847-16
Clinicaltrials.gov Identifier
Research summary
Because of the low incidence of rare oncogenic driver alterations and their presence across a variety of tumour types, large randomized studies for each alteration/ biomarker in individual tumour types is not feasible. Tumours harboring actionable oncogenic drivers may have better responses from therapy that specifically targets molecular alterations, which may therefore be a promising personalized treatment options. This trial will employ different cohorts, each with a specific study treatment (an umbrella platform study) where patients with same tumour types are matched to one of multiple possible treatment cohorts based on the presence of an oncogenic alteration. Recently trials have led to health authority approvals of pembrolizumab, larotrectinib, and entrectinib in tumouragnostic indications. Pembrolizumab is a programmed death receptor-1 (PD-1)-blocking antibody, FDA approved for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficiency solid tumours that have progressed on prior treatment or who have no satisfactory alternative treatment option. The TRK inhibitors larotrectinib and entrectinib are FDA approved for solid tumours harboring an NTRK gene fusion. Approximately 75% of oncologists report using NGS testing to guide treatment decisions. Despite this only 26.8% of oncologists responded that NGS test results often informed treatment recommendations, substantiating the need for additional drug and diagnostic development for widespread use of precision medicines and more personalized healthcare. Approximately 650 patients will be recruited globally with approximately 20 patients recruited at 5 UK sites. The study will last approximately 12 years from first patient screened to last patient last visit. The study is sponsored by F. Hoffman La Roche Research Summary; Version Number 1 dated April 2020
REC name
North West - Haydock Research Ethics Committee
REC reference
21/NW/0036
Date of REC Opinion
21 Apr 2021
REC opinion
Further Information Favourable Opinion