Evaluation of the Added Value of a Large Molecular Profiling Panel Versus a Limited Molecular Profiling Panel in Advanced Solid Tumors. (PROFILER 02)

May 6, 2022 updated by: Centre Leon Berard

A Multicentric, Prospective Cohort Study Aiming to Evaluate the Added Value of a Large Molecular Profiling Panel (Panel FoundationOne) Versus a Limited Molecular Profiling Panel (Panel CONTROL) in Advanced Solid Tumors.

The PROFILER 02 program is a multicenter, randomized, prospective cohort study aiming to compare the clinical relevance of a large Next-generation sequencing (NGS) panel (FondationOne or FOne panel) versus a limited NGS panel (CONTROL or CTL panel) in patients with advanced solid tumors.

This study will allow adapting the therapeutic management of these patients, if needed, by giving them recommended therapies (commercialized or in ongoing clinical trials), based on the recommendations of the Molecular Tumor Board (MTB).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The genetic and immunologic profile of the tumor will be determined from archival or fresh collected tumor sample.

For each patient, the tumor genomics data will be reviewed, at time of documented progressive disease, independently by a dedicated MTB to make a recommendation of therapy for a given patient based on its molecular profile. First, the genomics data issued from the panel defined by the randomization will be reviewed and recommended therapy resulting from randomization will be revealed to the Investigator. If a recommended therapy can be identified, this therapy will be recommended.

If none recommended therapy can be identified, the 2nd panel performed will then be reviewed.

In case of confirmed clinical or radiological progression (at Investigator's discretion) and/or unacceptable toxicity as per Investigator judgment during the line of therapy recommended by the MTB, the results of the second panel will be reviewed by MTB. Based on all genomics data available (i.e. randomized and 2nd panels), the MTB will recommend other treatment options. All results will be disclosed to Investigator in order to offer other treatment options.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
341

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Clermont-Ferrand, France
        • Centre Jean Perrin
      • Dijon, France
        • Centre Georges François Leclerc
      • Lille, France
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Centre Leon Berard
      • Lyon, France
        • Hopital Prive Jean Mermoz
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Marseille, France, 13915
        • AP-HM MARSEILLE - Hôpital Nord
      • Montpellier, France
        • Institut cancer Montpellier - ICM
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75231
        • Institut Curie
      • Rennes, France
        • Centre Eugène Marquis
      • Saint-Herblain, France, 44805
        • Ico Site Rene Gauducheau
      • Saint-Priest-en-Jarez, France, 422270
        • Institut de Cancérologie Lucien Neuwirth
      • Toulouse, France, 31059
        • Institut Claudius Regaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patient aged ≥ 18 years at time of inform consent signature.
  • Currently treated by a first or a second line of chemotherapy for their advanced cancer (local relapse or metastatic; Immunotherapies, Endocrine therapies and Targeted therapies are not considered as a line of chemotherapy).
  • Histologically confirmed diagnosis of advanced (local relapse or metastatic), incurable solid tumors from any histological types (except those listed in exclusion criteria 3).
  • I4. Availability of an adequate tumor sample to be sent imperatively to the CLB within 15 days after ICF signature by order of preference either (i1) a tumor archival FFPE block not older than 3 months prior to ICF signature or if not available :(ii2) a dedicated biopsy from one accessible lesion visible by medical imaging and accessible to percutaneous sampling with a diameter of at least 10 mm or if not feasible (3) an archival tumor sample (primary tumor or metastatic lesion) not older than 3 years at time of ICF signature. Quality (at least 20-30% of tumor cells) and quantity (sample size surface area > 5mm2 and > 90um depth) of the tumor sample have to be confirmed mandatorily within 7 days by a central pathological review before confirmation of inclusion.
  • Patient's disease which is not susceptible to progress during the next 45 days following the ICF signature.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.

  • Adequate organ and marrow function based on a medical records (within 21 days before randomization) as defined below :

    • Hemoglobin ≥ 9.0 g/dL
    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelets ≥ 100 x 109/L
    • Lymphocyte count ≥ 1 x 109/L
    • Serum creatinine CL > 50 mL/min per 1.73m2 using MDRD or CKD-EPI
    • AST and ALT ≤ 2.5 Upper Limit Normal (ULN) (up to 5 ULN may be tolerated in case of liver metastases)
    • Serum bilirubin ≤ 1. 5 ULN (in the absence of Gilbert's syndrome).
  • Patient should understand, sign, and date the written ICF prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
  • Patient must be covered by a medical insurance.

Exclusion Criteria:

  • Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication.
  • Any clinically significant and/or uncontrolled medical disease that could compromise the patient's ability to tolerate an anti-cancer treatment and its procedures (these conditions include but are not limited to severely impaired lung function, active gastrointestinal tract ulceration, acute or chronic uncontrolled liver disease/or severe renal disease, uncontrolled diabetes, history of HIV infection/or active viral infection (HBV, HCV), history of organ allograft or patient taking immunosuppressive treatment).

  • Patient with the following advanced cancers :

    • Cancer bearing one of the oncogenic driver mutation: Colorectal cancer : KRAS, NRAS, HRAS and BRAF/Lung cancer: ALK, EGFR, ROS or MET/Breast cancers : RH+ and/or HER2+
    • High-grade serous ovarian cancers platinum-sensitive,
    • Liposarcoma.
    • Melanoma: BRAF
  • Patient with non assessable tumor sample.
  • Patient already included in this study for a type of cancer, can't be included a second time for the same cancer or for any other type of cancer.
  • Pregnant or breastfeeding woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Large molecular profiling panel
This panel is FOne Panel with a 324 cancer-related gene.
Genetic: Blood and tumor samples
Evaluation of the added value of a large molecular profiling panel versus a limited molecular profiling panel
Other Names:
  • Evaluation of the added value of a molecular profiling panel
OTHER: Limited molecular profiling panel
This panel is CONTROL Panel with a 87 cancer-related gene.
Genetic: Blood and tumor samples
Evaluation of the added value of a large molecular profiling panel versus a limited molecular profiling panel
Other Names:
  • Evaluation of the added value of a molecular profiling panel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Compare the proportion of patients for whom a genomically identified recommended therapy could be initiated using the large NGS panel from FoundationOne versus the limited CONTROL panel.
Time Frame: 28 months
28 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare in the 2 randomization arms the number of patients with at least one actionable alteration.
Time Frame: 28 months
28 months
Compare in the 2 randomization arms the proportion of patients for which a genomically identified recommended therapy is effectively initiated.
Time Frame: 28 months
28 months
Describe in both arms the number of patients for whom a genomically identified recommended therapy was available but not initiated.
Time Frame: 28 months
28 months
Evaluate proportion of patients who could have been initiated a recommended therapy considering only the INCa panel.
Time Frame: 28 months
Evaluate proportion of patients with at least one actionable alteration and for whom a genomically identified recommended therapy could have been initiated considering only the INCa panel with only 16 cancer-related genes already included in CONTROL panel
28 months
Progression-Free Survival (PFS)
Time Frame: 24 months
Measured from the date of study drugs start to the date of the first objective radiological disease progression using RECIST 1.1 or death.
24 months
Overall response Rate (ORR)
Time Frame: 24 months
the most clinically favorable response recorded from the start of a recommended therapy until the end of treatment, according to RECIST 1.1
24 months
Duration of response (DoR)
Time Frame: 24 months
Calculated from date of first documented objective response (i.e., Complete Response or Partial Response) until date of first documented progression disease (measurements according to RECIST 1.1 criteria).
24 months
Patient Quality Of Life
Time Frame: 12 months
Measured by the questionnaire EuroQoL-5Dimension-3L
12 months
Perform a health economic evaluation
Time Frame: 12 months
A Cost-Effectiveness and a Cost-utility Analyses comparing the two molecular profiling strategies.
12 months
Perform a health economic evaluation
Time Frame: 12 months
A budget impact analysis to estimate the financial consequences of adoption and diffusion of the large FondationOne panel.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Leon Berard

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Pharma AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier Olivier, MD, Centre Leon Berard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 23, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ET16-115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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