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

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ClinicalTrials.gov Identifier: NCT04591431
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : January 26, 2023
Information provided by (Responsible Party):
Fondazione per la Medicina Personalizzata

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Gastrointestinal Cancer Non Small Cell Lung Cancer Other Cancer Drug: Erlotinib Drug: Trastuzumab Drug: Trastuzumab emtansine Drug: Pertuzumab Drug: Lapatinib Drug: Everolimus Drug: Vemurafenib Drug: Cobimetinib Drug: Alectinib Drug: Brigatinib Drug: Palbociclib Drug: Ponatinib Drug: Vismogedib Drug: Itacitinib Drug: Ipatasertib Drug: Entrectinib Drug: Atezolizumab Drug: Nivolumab Drug: Ipilimumab Drug: Pemigatinib Drug: Oncology Drugs Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, prospective, multicenter, Proof of Concept, Phase II clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tailored Therapy

Patients will be treated with target therapy and/or immunotherapy according to their genomic profile evidenced by the FO (Foundation One) profiling. Patients will be treated with one or more drugs of the following list according to their genomic profile and independently from their type of cancer:


IMMUNOTHERAPY (BIOMARKERS) ATEZOLIZUMAB, NIVOLUMAB, IPILIMUMAB (MSI, HIGH TUMOR MUTATIONAL BURDEN, OTHER ) Drugs will be administered according to their respective SmPCs (or IBs in case of drugs under development).

Drug: Erlotinib
TT arm

Drug: Trastuzumab
TT arm

Drug: Trastuzumab emtansine
TT arm

Drug: Pertuzumab
TT arm

Drug: Lapatinib
TT arm

Drug: Everolimus
TT arm

Drug: Vemurafenib
TT arm

Drug: Cobimetinib
TT arm

Drug: Alectinib
TT arm

Drug: Brigatinib
TT arm

Drug: Palbociclib
TT arm

Drug: Ponatinib
TT arm

Drug: Vismogedib
TT arm

Drug: Itacitinib
TT arm

Drug: Ipatasertib
TT arm

Drug: Entrectinib
TT arm

Drug: Atezolizumab
TT arm

Drug: Nivolumab
TT arm

Drug: Ipilimumab
TT arm

Drug: Pemigatinib
TT arm

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.
Drug: Oncology Drugs
Standard of Care Arm

Primary Outcome Measures :
  1. OVERALL RESPONSE RATE (ORR) [ Time Frame: 42 months ]

    Evaluation of the ORR of the Treatment at choice of physicians, according to Standard of Care (SoC) or of the Tailored Treatment (TT).

    The ORR will be constructed according to the specific design of the study, therefore including also the Rescue Therapy Phase data.

    This means that the ORR will take into account 3 evaluations:

    • on the original final population ( i.e 384 patients divided into the 4 groups of type of cancer)
    • on the TT patients, which will include the original randomized TT patients and the patients switched from the standard of care therapy (SoC therapy) to the TT Therapy, this latter within the Rescue Therapy Phase (patients switching upon the first documented progression)
    • on the population composed by the original TT patients, the original SoC patients and the switched TT patients. This means that the total population analyzed will include the original 384 population data (as per randomization) and the additional switched TT patients.

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) of SoC vs TT [ Time Frame: 42 months ]
  2. Time to Treatment Failure (TTF) of SoC vs TT [ Time Frame: 42 months ]
  3. Time to Next Treatment (TTNT) of SoC vs TT [ Time Frame: 42 months ]
  4. Concordance between molecular profile on tumor tissue and ctDNA [ Time Frame: 42 months ]
    Will be evaluated the concordance between Foundation One results on tumor tissue and blood sample. Overlapping mutational results will be considered as "concordant" otherwise will be considered as "discordant". Both qualitative and quantitative differences in mutational status will be considered.

  5. QoLs included in the two arms of the study of SoC vs TT [ Time Frame: 42 months ]
    The QoL score will be measured in the two arms of the study (SoC and TT), using the EORTC QLQ-C30, a validated questionnaire designed to assess different aspects of health and quality of life for cancer patients. Data from the two Quality of Life (QoL) questionnaires will be descriptively analyzed.

  6. The safety profile between the two treatment arms of SoC vs TT [ Time Frame: 42 months ]
    Percentage of Participants with Adverse Events (AEs) or Serious AEs (SAEs).

  7. Overall survival (OS) [ Time Frame: 42 months ]
    ● Overall survival (OS) is defined as the time from randomization to death from any cause. Data for patients with no record of death will be censored at the last date they were known to be alive. The analysis of OS will follow the same methodology as the primary endpoint.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 18 at time of signing Informed Consent Form
  2. Patients able and willing to provide a written informed consent to participate to the study
  3. Patients with recurrent/metastatic breast, gastrointestinal cancer,non small cell lung cancer or others
  4. Patients not treatable with potentially curative surgery ot other loco-regional treatments.
  5. Patients should have been completed at least 1 line of treatment for breast cancer, gastro-intestinal, non small cell lung cancer or other cancer
  6. ECOG performance status from 0 to 1
  7. Molecular target not actionable with approved drugs identified during screening by profiling with Foundation One on biopsy and Foundation ACT on blood
  8. Biopsiable disease (tumor biopsy mandatory for tumor profiling). The biopsy must be performed during the screening period, when patients complete the conventional therapy for their recurrent/metastatic cancer. Historical samples will be considered for the study if collected within 3 months before the ICF signature of the patient. Samples older than 3 months, with a maximum timeframe of 6 months, will be considered upon clinical judgement of the Investigator.
  9. Measurable disease, eligible to standard treatment. Patients must have measurable or evaluable disease defined, per RECIST 1.1 or irCS (immune related Response Criteria), as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral computed tomography (CT) scan, Magnetic Resonance Imaging (MRI), or a subcutaneous or superficial lesion that can be measured with calipers by clinical exam. For lymph nodes, the short axis must be ≥15 mm. Patients who have assessable disease by physical or radiographic examination but do not fully meet the above definitions of measurable disease (but still remains measurable) are eligible and will be considered to have evaluable disease. Patient's whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only) are NOT eligible. PET scan could be performed, if clinically indicated. For PET response evaluation PERCIST criteria will be applied.
  10. Adequate renal function defined by a serum creatinine <1.5xUNL (upper normal limit).
  11. Adequate liver function test defined by SGOT & SGPT <3xUNL (5xUNL in case of liver metastases), and bilirubin level <1.5xUNL
  12. Adequate bone marrow function defined by platelets >100,000/mm3, hemoglobin >10 g/dL, and neutrophils >1,000/mm3
  13. For female of child-bearing potential and for all women < 1 years after the onset of menopause: a negative pregnancy test <72 hours before starting study treatment is required. If sexually active, female of childbearing potential must use "highly effective" methods of contraception for the study duration. Contraception should continue after the last treatment for 3 months or for longer periods according to what reported in the Appendix 1 of the Protocol
  14. For male of reproductive potential: any sexually active male patient must use a condom while on study treatment. Contraception should continue after the last treatment for 3 months or for longer periods according to what reported in the Appendix 1 of the Protocol.

Exclusion Criteria:

  1. Patients who have only bone and/or brain metastases
  2. Patients treated with more than 2 lines for breast cancer, gastro-intestinal, non small cell lung cancer and other cancer
  3. Patients whose brain metastases have not been monitored for >2 months
  4. Patients with well-established actionable targets for which approved and marketed targeted drugs are available (i.e. lung cancer with EGFR mutation, or ALK translocation, B-RAF mutant melanoma, GIST with KIT mutations or breast cancer with HER2 amplification)
  5. Patient participating in another clinical trial with an experimental drug
  6. Anticoagulation with anti-vitamin K (Low Molecular Weight Heparin [LMWH] is allowed)
  7. Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, including uncontrolled diabetes, cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, chronic liver or renal disease, active gastrointestinal tract ulceration, severely impaired lung function
  8. Pregnant and/or breastfeeding women
  9. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  10. HIV, HBV, or HCV infection as per specific test performed at the screening visit or known as per Medical History
  11. Patients with documented contraindication to any of the IMPs that will be used for the study, as reported in the respective SmPcs/IBs and in Appendix 2
  12. Patients treated with the following drugs, because of the risk of immunosuppression: Chronic or high-dose oral corticosteroid therapy, TNF-inhibitors and Anti-T cell antibodies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04591431

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Contact: Silvia Violetti +390683977939 silvia.violetti@clinicaltrialsfmp.it
Contact: Elisabetta Agostini +390683977939 elisabetta.agostini@clinicaltrialsfmp.it

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Sponsors and Collaborators
Fondazione per la Medicina Personalizzata
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Study Chair: Paolo Marchetti Fondazione per la Medicina Personalizzata
Principal Investigator: Andrea Botticelli Università degli Studi di Roma Sapienza
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Responsible Party: Fondazione per la Medicina Personalizzata
ClinicalTrials.gov Identifier: NCT04591431    
Other Study ID Numbers: MAR-BAS-18-005
2018-002190-21 ( EudraCT Number )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Ado-Trastuzumab Emtansine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators