Table 1

Main tumor agnostic/biomarker driven clinical trials based on NGS analysis active in Italy (December 2021)

Trial nameMolecular driverTargeted agentStudy designPopulation
Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study (NCT04589845)
  • ROS1 fusions

  • NTRK1/2/3 fusion

  • ALK fusion

  • TMB high

  • AKT1/2/3 mutation

  • HER2 mutation

  • MDM2-amplified, TP53 wild-type

  • PIK3CA mutation

  • BRAF class II–III mutations

  • RET fusion

  • Entrectinib

  • Alectinib

  • Atezolizumab

  • Ipatasertib

  • Trastuzumab emtansine

  • Idasanutlin

  • Inavolisib

  • Belvarafenib

  • Pralsetinib

Phase II, multicohortAdvanced solid tumors
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors (NCT04931342)
  • PTEN loss of function mutations

  • AKT1/2/3 mutation

  • PIK3CA mutation

  • ERBB2 mutation or amplification

  • Ipatasertib

  • Cobimetinib

  • Trastuzumab emtansine

  • Atezolizumab

  • Bevacizumab

  • Paclitaxel

Phase II, multicohortPersistent or recurrent rare epithelial ovarian cancers
Safety and Efficacy of Retifanlimab alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. (POD1UM-204) (NCT04463771)
  • MSI high

  • TMB high

  • POLE mutations

  • FGFR 1,2,3 mutation or alteration

  • Retifanlimab

  • Epacadostat

  • Pemigatinib

Phase II, multicohortAdvanced or metastatic endometrial cancer
A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations (NCT04083976)
  • FGFR gene alterations

  • Erdafitinib

Phase II, single cohortAdvanced solid tumor
The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy (ROME) (NCT04591431)
  • EGFR mutation

  • ERBB2 amplification or mutation

  • mTOR mutation

  • AKT mutation

  • BRAF V600E mutation

  • CDK 4/6 mutation

  • CDKN2A mutation

  • BCR-ABL gene fusion

  • SMO/PTCH1 mutation

  • JAK mutation

  • FGFR 1-2-3 gene alterations

  • PI3KCA, AKT, PTEN mutations

  • NTRK 1-2-3 fusion

  • ROS1 fusion

  • MSI high

  • TMB high

  • Erlotinib

  • Trastuzumab

  • Trastuzumab emtansine

  • Pertuzumab

  • Lapatinib

  • Everolimus

  • Vemurafenib

  • Cobimetinib

  • Alectinib

  • Brigatinib

  • Palbociclib

  • Ponatinib

  • Vismogedib

  • Itacitinib

  • Ipatasertib

  • Entrectinib

  • Atezolizumab

  • Nivolumab

  • Ipilimumab

  • Pemigatinib

Randomized, phase IIAdvanced solid tumor
  • NGS, next generation sequencing .