Trial · NCT04591431
The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy
NCT04591431, Phase 2, Unknown, Fondazione per la Medicina Personalizzata
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy. Trials, record NCT04591431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04591431
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy
- NCT number
- NCT04591431
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 400 participants, actual
- Lead sponsor
- Fondazione per la Medicina Personalizzata
- Conditions
- Breast Cancer, Gastrointestinal Cancer, Non Small Cell Lung Cancer, Other Cancer
- Interventions
Erlotinib, Trastuzumab, Trastuzumab emtansine, Pertuzumab, Lapatinib, Everolimus, Vemurafenib, Cobimetinib, Alectinib, Brigatinib, Palbociclib, Ponatinib, Vismogedib, Itacitinib, Ipatasertib, Entrectinib, Atezolizumab, Nivolumab, Ipilimumab, Pemigatinib, Oncology Drugs, Pralsetinib, Selpercatinib, Talazoparib, Tepotinib, Alpelisib
- First posted
- 2020-10-19
- Last updated
- 2023-10-03
- Other registries' IDs
- eudract:2018-002190-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | OVERALL RESPONSE RATE (ORR) | 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 | Progression Free Survival (PFS) of SoC vs TT | 42 months | |
| Secondary | Time to Treatment Failure (TTF) of SoC vs TT | 42 months | |
| Secondary | Time to Next Treatment (TTNT) of SoC vs TT | 42 months | |
| Secondary | Concordance between molecular profile on tumor tissue and ctDNA | 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. |
| Secondary | QoLs included in the two arms of the study of SoC vs TT | 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. |
| Secondary | The safety profile between the two treatment arms of SoC vs TT | 42 months | Percentage of Participants with Adverse Events (AEs) or Serious AEs (SAEs). |
| Secondary | Overall survival (OS) | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04591431
GET https://conductscience.org/api/trials/v1/NCT04591431/registered