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

NCT ID: NCT03163732

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 341 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-29
• Study Completion Date: 2021-11-23

Brief Summary

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).

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Large molecular profiling panel

This panel is FOne Panel with a 324 cancer-related gene.

Group Type: OTHER

Blood and tumor samples

Intervention Type: GENETIC

Evaluation of the added value of a large molecular profiling panel versus a limited molecular profiling panel

Limited molecular profiling panel

This panel is CONTROL Panel with a 87 cancer-related gene.

Group Type: OTHER

Blood and tumor samples

Intervention Type: GENETIC

Evaluation of the added value of a large molecular profiling panel versus a limited molecular profiling panel

Interventions

Blood and tumor samples

Evaluation of the added value of a large molecular profiling panel versus a limited molecular profiling panel

Intervention Type: GENETIC

Other Intervention Names

Evaluation of the added value of a molecular profiling panel

Eligibility Criteria

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).

Exclusion Criteria

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Olivier, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

Institut Bergonié

Bordeaux, , France

Centre Jean PERRIN

Clermont-Ferrand, , France

Centre Georges François LECLERC

Dijon, , France

Centre Oscar Lambret

Lille, , France

Centre Léon Bérard

Lyon, , France

Hôpital Privé Jean Mermoz

Lyon, , France

Institut Paoli Calmettes

Marseille, , France

AP-HM MARSEILLE - Hôpital Nord

Marseille, , France

Institut cancer Montpellier - ICM

Montpellier, , France

Institut Curie

Paris, , France

Hopital Tenon

Paris, , France

Centre Eugène Marquis

Rennes, , France

ICO site René Gauducheau

Saint-Herblain, , France

Institut de Cancérologie Lucien NEUWIRTH

Saint-Priest-en-Jarez, , France

Institut Claudius Regaud

Toulouse, , France

Countries

France

References

Tredan O, Pouessel D, Penel N, Chabaud S, Gomez-Roca C, Delord JP, Pannier D, Brahmi M, Fabbro M, Garcia ME, Larrieu-Ciron D, Ray-Coquard I, Viala M, Italiano A, Tosi D, Cassier P, Dufresne A, Attignon V, Boyault S, Treilleux I, Viari A, Perol D, Blay JY. Broad versus limited gene panels to guide treatment in patients with advanced solid tumors: a randomized controlled trial. Nat Med. 2025 May;31(5):1502-1508. doi: 10.1038/s41591-025-03613-x. Epub 2025 Apr 7.

Reference Type: DERIVED

PMID: 40195451 (View on PubMed)

Other Identifiers

ET16-115

Identifier Type: -

Identifier Source: org_study_id