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 : November 9, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||384 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, prospective, multicenter, Proof of Concept, Phase II clinical trial|
|Masking:||None (Open Label)|
|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|
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:
TARGETED THERAPY (MOLECULAR TARGET) 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)
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: Trastuzumab emtansine
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
- 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.
- Progression Free Survival (PFS) of SoC vs TT [ Time Frame: 42 months ]
- Time to Treatment Failure (TTF) of SoC vs TT [ Time Frame: 42 months ]
- Time to Next Treatment (TTNT) of SoC vs TT [ Time Frame: 42 months ]
- 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.
- 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.
- 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).
- 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.
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
|Contact: Silvia Violettiemail@example.com|
|Contact: Elisabetta Agostinifirstname.lastname@example.org|
|Study Chair:||Paolo Marchetti||Fondazione per la Medicina Personalizzata|
|Principal Investigator:||Andrea Botticelli||Università degli Studi di Roma Sapienza|