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

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ClinicalTrials.gov Identifier: NCT03163732
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Centre Leon Berard

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).


Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Genetic: Blood and tumor samples Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Arm A: Tumor-based genomics according to the 324 cancer-related genes Next Generation Sequencing (NGS) panel from Foundation One (FOne panel).
  • Arm B: Tumor-based genomics according to the 87 cancer-related genes NGS panel performed at Centre Leon Berard "Unité de Caractérisation Tumorale" (CONTROL panel).

Both panels will be performed concomitantly for all patients using the same patient tumor specimen.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.
Actual Study Start Date : June 29, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
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 Name: Evaluation of the added value of a molecular profiling panel

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 Name: Evaluation of the added value of a molecular profiling panel




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Compare in the 2 randomization arms the number of patients with at least one actionable alteration. [ Time Frame: 28 months ]
  2. Compare in the 2 randomization arms the proportion of patients for which a genomically identified recommended therapy is effectively initiated. [ Time Frame: 28 months ]
  3. Describe in both arms the number of patients for whom a genomically identified recommended therapy was available but not initiated. [ Time Frame: 28 months ]
  4. 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

  5. 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.

  6. 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

  7. 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).

  8. Patient Quality Of Life [ Time Frame: 12 months ]
    Measured by the questionnaire EuroQoL-5Dimension-3L

  9. Perform a health economic evaluation [ Time Frame: 12 months ]
    A Cost-Effectiveness and a Cost-utility Analyses comparing the two molecular profiling strategies.

  10. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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): NCT03163732


Contacts
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Contact: Olivier TREDAN, MD +33478782828 olivier.tredan@lyon.unicancer.fr

Locations
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France
Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Antoine ITALIANO, MD    +33 (0)5 56 33 32 44    a.italiano@bordeaux.unicancer.fr   
Principal Investigator: Antoine ITALIANO, MD         
Sub-Investigator: Sophie COUSIN, MD         
Sub-Investigator: Maud TOULMONDE, MD         
Sub-Investigator: Mathilde CABART, MD         
Centre Jean PERRIN Recruiting
Clermont-Ferrand, France
Contact: Xavier DURANDO, MD    + 33 4 73 27 80 00    xavier.durando@cjp.fr   
Principal Investigator: Xavier DURANDO, MD         
Sub-Investigator: Maureen BERNADACH, MD         
Sub-Investigator: Sophie DUBOIS, MD         
Sub-Investigator: Pascale DUBRAY LONGERAS, MD         
Sub-Investigator: Morgane MASSON, MD         
Sub-Investigator: Marie-Ange MOURET REYNIER, MD         
Sub-Investigator: Camille POIRIER, MD         
Centre Georges François LECLERC Recruiting
Dijon, France
Contact: François GHIRINGHELLI, MD         
Principal Investigator: François GHIRINGHELLI, MD         
Sub-Investigator: Leila BENGRINE LEFEVRE, MD         
Sub-Investigator: Isabelle DESMOULINS, MD         
Sub-Investigator: Laure FAVIER, MD         
Sub-Investigator: Siavoshe AYATI, MD         
Sub-Investigator: Bruno COUDERT, MD         
Sub-Investigator: Jean-Florian GUION, MD         
Sub-Investigator: Audrey HENNEQUIN, MD         
Sub-Investigator: Nicolas ISAMBERT, MD         
Sub-Investigator: Aurélie LAGRANGE, MD         
Sub-Investigator: Sylvie ZANETTA, MD         
Sub-Investigator: Julie VINCENT, MD         
Sub-Investigator: Armony PARADIS, MD         
Sub-Investigator: Sylvain LADOIRE, MD         
Sub-Investigator: Alice HERVIEU, MD         
Centre Oscar Lambret Recruiting
Lille, France
Contact: Nicolas Paul PENEL, MD       n-penel@o-lambret.fr   
Principal Investigator: Nicolas Paul PENEL, MD         
Sub-Investigator: Aurélien CARNOT, MD         
Sub-Investigator: Cyril ABDEDDAIM, MD         
Sub-Investigator: Eric DANSIN, MD         
Sub-Investigator: Farid EL HAJBI, MD         
Sub-Investigator: Emilie KACZMAREK, MD         
Sub-Investigator: Fredrik LAESTADIUS, MD         
Sub-Investigator: Gautier LEFEBVRE, MD         
Sub-Investigator: Audrey MAILLIEZ, MD         
Sub-Investigator: Diane PANNIER, MD         
Sub-Investigator: Thomas RYCKEWAERT, MD         
Sub-Investigator: Jacques BONNETERRE, MD         
Sub-Investigator: Annick F. CHEVALIER-PLACE, MD         
Sub-Investigator: Natacha STERN, MD         
Centre Léon Bérard Recruiting
Lyon, France, 69008
Sub-Investigator: Virginie AVRILLON, MD         
Sub-Investigator: Thomas BACHELOT, MD         
Sub-Investigator: Olivia BALLY, MD         
Sub-Investigator: Alice BONNEVILLE-LEVARD, MD         
Sub-Investigator: Jean-Yves BLAY, MD         
Sub-Investigator: Helen BOYLE, MD         
Sub-Investigator: Mehdi BRAHMI, MD         
Sub-Investigator: Philippe CASSIER, MD         
Sub-Investigator: Olfa DERBEL MILED, MD         
Sub-Investigator: Françoise DESSEIGNE, MD         
Sub-Investigator: Jérôme FAYETTE, MD         
Sub-Investigator: Aude FLECHON, MD         
Sub-Investigator: Christelle DE LA FOUCHARDIERE, MD         
Sub-Investigator: Didier FRAPPAZ, MD         
Sub-Investigator: Pierre GUIBERT, MD         
Sub-Investigator: Pierre-Etienne HEUDEL, MD         
Sub-Investigator: Nathalie MARQUES, MD         
Sub-Investigator: Sylvie NEGRIER, MD         
Sub-Investigator: Eve-Marie NEIDHARDT, MD         
Sub-Investigator: Valérie PAULUS, MD         
Sub-Investigator: Maurice PEROL, MD         
Sub-Investigator: Isabelle RAY-COQUARD, MD         
Sub-Investigator: Paul REBATTU, MD         
Sub-Investigator: Pierre SAINTIGNY, MD         
Sub-Investigator: Matthieu SARABI, MD         
Sub-Investigator: Catherine TERRET, MD         
Sub-Investigator: Philippe TOUSSAINT, MD         
Principal Investigator: Olivier TREDAN, MD         
Sub-Investigator: Louis DOUBLET, MD         
Sub-Investigator: Armelle DUFRESNE, MD         
Sub-Investigator: Lauriane EBERST, MD         
Sub-Investigator: Guillaume MORICEAU, MD         
Sub-Investigator: Juliette REURE, MD         
Sub-Investigator: Pauline ROCHEFORT, MD         
Institut Paoli Calmettes Recruiting
Marseille, France, 13273
Contact: François BERTUCCI    +33 4 91 22 35 37    bertuccif@ipc.unicancer.fr   
Principal Investigator: François BERTUCCI, MD         
Sub-Investigator: Marine GILABERT, MD         
Sub-Investigator: Anthony GONCALVES, MD         
Sub-Investigator: Gwenaëlle GRAVIS, MD         
Sub-Investigator: Audrey MONNEUR, MD         
Sub-Investigator: Magali PROVENSAL, MD         
AP-HM MARSEILLE - Hôpital Nord Recruiting
Marseille, France, 13915
Contact: Fabrice BARLESI, MD    +33 (0)4 91 96 59 01    fabrice.barlesi@ap-hm.fr   
Sub-Investigator: Clotilde FOURNIER, MD         
Principal Investigator: Fabrice BARLESI, MD         
Sub-Investigator: Marie-Eve GARCIA, MD         
Sub-Investigator: Laurent GREILLIER, MD         
Sub-Investigator: Céline MASCAUX, MD         
Sub-Investigator: Pascale TOMASINI, MD         
Sub-Investigator: Arnaud BOYER, MD         
Sub-Investigator: Arnaud JEANSON, MD         
Institut cancer Montpellier - ICM Recruiting
Montpellier, France
Contact: Diego TOSI, MD    +33 4 67 61 25 81    Diego.Tosi@icm.unicancer.fr   
Sub-Investigator: Diego TOSI, MD         
Sub-Investigator: Ernesto José LOPEZ MARTINEZ, MD         
Sub-Investigator: Marie VIALA, MD         
Sub-Investigator: Antoine ADENIS, MD         
Sub-Investigator: Marie ALEXANDRE, MD         
Sub-Investigator: David AZRIA, MD         
Sub-Investigator: Pierre BOISSELIER, MD         
Sub-Investigator: Marie CHARISSOUX, MD         
Sub-Investigator: Laurence CRISTOL-DALSTEIN, MD         
Sub-Investigator: Didier CUPISSOL, MD         
Sub-Investigator: Amélie DARLIX, MD         
Sub-Investigator: Véronique D'HONDT, MD         
Sub-Investigator: Michel FABBRO, MD         
Sub-Investigator: Catherine FAVIER, MD         
Sub-Investigator: Nelly FIRMIN, MD         
Sub-Investigator: Blandine GALLET-SUCHET, MD         
Sub-Investigator: Séverine GUIU, MD         
Sub-Investigator: William JACOT, MD         
Sub-Investigator: Thibault MAZARD, MD         
Sub-Investigator: Fabienne PORTALES, MD         
Sub-Investigator: Stéphane POUDEROUX, MD         
Sub-Investigator: Xavier QUANTIN, MD         
Sub-Investigator: Olivier RIOU, MD         
Sub-Investigator: Emmanuelle SAMALIN, MD         
Sub-Investigator: Marc YCHOU, MD         
Institut Curie Not yet recruiting
Paris, France, 75231
Contact: Christophe LE TOURNEAU, MD    + 33 5 31 15 51 01    christophe.letourneau@curie.fr   
Principal Investigator: Christophe LE TOURNEAU, MD         
Sub-Investigator: Delphine LOIRAT, MD         
Sub-Investigator: Francesco RICCI, MD         
Hopital Tenon Not yet recruiting
Paris, France, 75970
Contact: Jacques CADRANEL    +33 1 56 01 65 31    jacques.cadranel@aphp.fr   
Principal Investigator: Jacques CADRANEL, MD         
Sub-Investigator: Anthony CANELLAS, MD         
Sub-Investigator: Christelle EPAUD, MD         
Sub-Investigator: Vincent FALLET, MD         
Centre Eugène Marquis Recruiting
Rennes, France
Contact: Thibaut DE LA MOTTE ROUGE, MD    +33 2 99 25 31 79    t.delamotterouge@rennes.unicancer.fr   
Principal Investigator: Thibaut DE LA MOTTE ROUGE, MD         
Sub-Investigator: Lise BOUSSEMART, MD         
Sub-Investigator: Laurence CROUZET, MD         
Sub-Investigator: Véronique DIERAS, MD         
Sub-Investigator: Monica DINULESCU, MD         
Sub-Investigator: Julien EDELINE, MD         
Sub-Investigator: Brigitte LAGUERRE, MD         
Sub-Investigator: Claire LARIBLE, MD         
Sub-Investigator: Fanny LE DU, MD         
Sub-Investigator: Claudia LEFEUVRE, MD         
Sub-Investigator: Thierry LESIMPLE, MD         
Sub-Investigator: Samuel LESOURD, MD         
Sub-Investigator: Astrid LIEVRE, MD         
Sub-Investigator: Christophe PERRIN, MD         
Sub-Investigator: Marc PRACHT, MD         
Sub-Investigator: Elodie VAULEON, MD         
Sub-Investigator: Eugenie RIGAULT, MD         
ICO site René Gauducheau Recruiting
Saint-Herblain, France, 44805
Contact: Mario CAMPONE    + 33 2 40 67 99 77    mario.campone@ico.unicancer.fr   
Principal Investigator: Mario CAMPONE, MD         
Sub-Investigator: Dominique BERTON-RIGAUD, MD         
Sub-Investigator: Emmanuelle BOMPAS, MD         
Sub-Investigator: Emmanuelle BOURBOULOUX, MD         
Sub-Investigator: Pauline DU RUSQUEC, MD         
Sub-Investigator: Jean-Sébastien FRENEL, MD         
Sub-Investigator: Carole GOURMELON, MD         
Sub-Investigator: Sandrine HIRET, MD         
Sub-Investigator: Judith RAIMBOURG, MD         
Sub-Investigator: Jean-Luc RAOUL, MD         
Sub-Investigator: Marie ROBERT, MD         
Sub-Investigator: Frédéric ROLLAND, MD         
Sub-Investigator: Audrey ROLLOT, MD         
Sub-Investigator: Helene SENELLART, MD         
Sub-Investigator: Damien VANSTEENE, MD         
Institut de Cancérologie Lucien NEUWIRTH Recruiting
Saint-Priest-en-Jarez, France, 422270
Contact: Olivier COLLARD, MD         
Principal Investigator: Olivier COLLARD, MD         
Sub-Investigator: Pierre FOURNEL, MD         
Sub-Investigator: Aline GUILLOT, MD         
Sub-Investigator: Jean-Philippe JACQUIN, MD         
Sub-Investigator: Romain RIVOIRARD, MD         
Sub-Investigator: Léa SABAN-ROCHE, MD         
Sub-Investigator: Cécile VASSAL, MD         
Institut Claudius Regaud Recruiting
Toulouse, France, 31059
Contact: Jean-Pierre DELORD, MD    +33 (0)5 31 15 51 01    delord.jean-pierre@iuct-oncopole.fr   
Principal Investigator: Jean-Pierre DELORD, MD         
Sub-Investigator: Carlos-Alberto GOMEZ-ROCA, MD         
Sub-Investigator: Sarah BETRIAN-LAGARDE, MD         
Sub-Investigator: Christine CHEVREAU, MD         
Sub-Investigator: Ewa-Anna COTTURA, MD         
Sub-Investigator: Florence DALENC, MD         
Sub-Investigator: LoÏc MOUREY, MD         
Sub-Investigator: Damien POUESSEL, MD         
Sub-Investigator: Audrey RABEAU, MD         
Sub-Investigator: Mony UNG, MD         
Sub-Investigator: Thibaud VALENTIN, MD         
Sub-Investigator: Laurence GLADIEFF, MD         
Sub-Investigator: Delphine LARRIEU-CIRON, MD         
Sponsors and Collaborators
Centre Leon Berard
Roche Pharma AG
Investigators
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Principal Investigator: Olivier Olivier, MD Centre Leon Berard

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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT03163732     History of Changes
Other Study ID Numbers: ET16-115
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: December 2018
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
Keywords provided by Centre Leon Berard:
Solid tumor
Advanced tumor
Profiling panel
Additional relevant MeSH terms:
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Neoplasms