The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Sponsor
Fondazione per la Medicina Personalizzata
Study ID
NCT04591431
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib — DRUG
    TT arm
  • Trastuzumab — DRUG
    TT arm
  • Trastuzumab emtansine — DRUG
    TT arm
  • Pertuzumab — DRUG
    TT arm
  • Lapatinib — DRUG
    TT arm
  • Everolimus — DRUG
    TT arm
  • Vemurafenib — DRUG
    TT arm
  • Cobimetinib — DRUG
    TT arm
  • Alectinib — DRUG
    TT arm
  • Brigatinib — DRUG
    TT arm
  • Palbociclib — DRUG
    TT arm
  • Ponatinib — DRUG
    TT arm
  • Vismogedib — DRUG
    TT arm
  • Itacitinib — DRUG
    TT arm
  • Ipatasertib — DRUG
    TT arm
  • Entrectinib — DRUG
    TT arm
  • Atezolizumab — DRUG
    TT arm
  • Nivolumab — DRUG
    TT arm
  • Ipilimumab — DRUG
    TT arm
  • Pemigatinib — DRUG
    TT arm
  • Oncology Drugs — DRUG
    Standard of Care Arm
  • Pralsetinib — DRUG
    TT arm
  • Selpercatinib — DRUG
    TT arm
  • Talazoparib — DRUG
    TT arm
  • Tepotinib — DRUG
    TT arm
  • Alpelisib — DRUG
    TT arm

Study Details

This is a randomized, prospective, multicenter, Proof of Concept, Phase II clinical trial Study. The main objective of the study is to evaluate the efficacy (meant as overall response rate ORR) of TT (targeted Therapy) vs SoC (standard of Care) in patients with progressive disease (recurrent and/or metastatic) of breast cancer, metastatic gastro-intestinal tumors, non small cell lung cancer (NSCLC) or others. Patients should have completed at least 1 line of treatment and no more than 2 as defined by the current version of the AIOM (Italian Association of Medical Oncology) guidelines. Patients are included if surgery is contraindicated.

Key Dates

Start date
Oct 7, 2020
Status verified
Oct 2023
Primary completion
Dec 31, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
400 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tailored Therapy
    Experimental (TT) Patients will be treated with target therapy and/or immunotherapy according to their genomic profile evidenced by Foundation One test and independently from their type of cancer with one or more drugs of the following list (administered according to the SmPCs or IBs if under development): TARGET THERAPY: ERLOTINIB (EGFR mutation) TRASTUZUMAB, PERTUZUMAB, TDM1, LAPATINIB (ERBB2 amplifications/mut) EVEROLIMUS (mTOR mutations, AKT mut) VEMURAFENIB, COBIMETINIB (BRAFV600E mutations) ALECTINIB, BRIGATINIB (ALK, RET) PALBOCICLIB (CDK4/6, CDKN2A/p16) PONATINIB (Bcr-abl) VISMODEGIB (SMO/PTCH1) ITACITINIB (JAK mutation) INCB054828 (FGFR1/2/3) IPATASERTIB (PI3K, AKT, PTEN) ENTRECTINIB (NTRK1/2/3 -TRK fusion proteins-, ROS1) ALPELISIB (PI3K, AKT) TEPOTINIB (MET amplification/exon14 skipping mutations) PRALSETINIB (RET) TALAZOPARIB (BRCA1/2, ATM, other HRD status) SELPERCATINIB (RET) IMMUNOTHERAPY: ATEZOLIZUMAB, NIVOLUMAB, IPILIMUMAB (MSI, HIGH TUMOR MUTATIONAL BURDEN, OTHER)
  • Active Comparator: Standard of Care
    Patients will be treated according the current version of the AIOM (Italian Association of Medical Oncology) guidelines for their type of cancer. As an example, patients could be treated with standard chemotherapy and/or targeted therapy according to the histological results.

Primary Outcome Measure

OVERALL RESPONSE RATE (ORR) [ Time Frame: 42 months ]

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