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Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET) (PLANET)

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ClinicalTrials.gov Identifier: NCT05099068
Recruitment Status : Recruiting
First Posted : October 29, 2021
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Study Description
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Brief Summary:
The proposal is to conduct a prospective, multi-cohort study aiming to decipher molecular profiles/biological characteristics of advanced cancer patients during the course of their disease with longitudinal and sequential analyses of tumor and liquid biopsies. This approach will allow i) to develop a model in order to predict tumor response / resistance in real life conditions and to better understand adaptive mechanisms and ii) to potentially propose therapeutic options to enrolled patients following the review of the biological/molecular data generated during this study and during a Molecular Tumor Board in case of disease progression. This study will include 12 cohorts according to tumor type and standard treatment received (See Inclusion criteria I1). Patient will be enrolled before the initiation of standard anti-cancer treatment.

Condition or disease Intervention/treatment Phase
Advanced / Metastic Solid Tumors Glioblastoma Chronic Leukemia Lymphocytic Biological: Blood and tumor samples Not Applicable

Detailed Description:

Most of the molecular screening programs have allowed to successfully guide patients to personalized therapy only for a minority of patients (10-20%) and few patients have actually benefit from these programs with low objective response under personalized therapy.

During the course of disease and / or of treatment, tumors become more heterogeneous and include a collection of cells harboring distinct molecular signatures with differential levels of sensitivity to treatment. Assessment of tumor heterogeneity and plasticity are essential for the development of effective therapies. Longitudinal analysis of biopsy samples is of considerable interest to assess the complex clonal architecture of cancers and potentially adapt cancer treatment to tumor profile/characteristics overtime. In this context, profiling of circulating tumor DNA using non-invasive liquid biopsies is also an interesting approach to assess cancer evolution by showing the contribution of clonal heterogeneity to chemotherapy resistance and metastasis in high-risk patients.

The proposal is to conduct a prospective, multi-cohort study aiming to decipher molecular profiles/biological characteristics of advanced cancer patients during the course of their disease with longitudinal and sequential analyses of tumor and liquid biopsies. This approach will allow i) to develop a model in order to predict tumor response / resistance in real life conditions and to better understand adaptive mechanisms and ii) to potentially propose therapeutic options to enrolled patients following the review of the biological/molecular data generated during this study and during a Molecular Tumor Board in case of disease progression. This study will include 12 cohorts according to tumor type and standard treatment received (See Inclusion criteria I1). Patient will be enrolled before the initiation of standard anti-cancer treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Longitudinal Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : September 15, 2025
Estimated Study Completion Date : September 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: IMMUNOTHERAPY COHORTS
This cohort include following cancers treated with immunotherapy : metastatic Small cell lung cancer (SLCC); recurrent/Metastatic Head and Neck squamous cell carcinoma (HNSCC); MSI-High, any tumor types and HPV-related cancers,any tumor types
 Biological: Blood and tumor samples
Longitudinal molecular profiling of tumor and liquid biopsies.
Experimental: TARGETED THERAPIES COHORTS
This cohort include following cancers treated with targeted therapies : Metastatic GIST; BRAF-mutated tumors (CRC (BRAF V600E), lung (V600 only) and thyroid (all BRAF mutation with known sensitivity to Dabrafenib) cancer); All solid tumor types with RET fusion / mutation and Chronic Lymphocytic Leukemia (CLL) in the relapsed setting.
 Biological: Blood and tumor samples
Longitudinal molecular profiling of tumor and liquid biopsies.
Experimental: CHEMOTHERAPY COHORTS
This cohort include following cancers treated with chemotherapies : metastatic Small cell lung cancer (SLCC); recurrent/Metastatic Head and Neck squamous cell carcinoma (HNSCC); Metastatic Triple negative breast cancer (TNBC); Glioblastoma; Advanced high grade epithelial ovarian cancer
 Biological: Blood and tumor samples
Longitudinal molecular profiling of tumor and liquid biopsies.


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with meaningful molecular genetic alterations on tumor sample [ Time Frame: At the end of study (4 years) ]
    Identification of molecular genetic alterations based on molecular characterisation (WES and RNASeq) of tumor at diagnosis, then under standard anti-cancer treatment : treatment start, 1st radiological evaluation and disease progression

  2. Number of patients with meaningful molecular genetic alterations on circulating tumour DNA (ctDNA) [ Time Frame: At the end of study (4 years) ]
    Identification of molecular genetic alterations based on molecular characterisation (WES and RNASeq) of ctDNA under standard anti-cancer treatment : treatment start, each radiological evaluation and disease progression

  3. Number of patients with meaningful immunological features [ Time Frame: At the end of study (4 years) ]
    Identification and characterisation of the tumor microenvironment and the host's immunological profile, at diagnosis and during patient treatment

  4. Objective Response Rate (ORR) as per RECIST V1.1 and according to central review [ Time Frame: 3 months ]
    For solid tumors excluding glioblastoma only

  5. Progression-Free Survival (PFS) [ Time Frame: 6 months ]
    For glioblastoma only

  6. Objective Response Rate (ORR) according to iwCLL criteria [ Time Frame: 6 months ]
    For chronic lymphocytic leukemia


Secondary Outcome Measures :
  1. Correlation between disease evolution and molecular and/or immunological biomarkers [ Time Frame: Time Frame: up to 4 years ]
    To identify potential prognostic and predictive biomarkers on tumor samples collected during patient's treatment and follow-up detected by molecular biology techniques, and on immunological findings

  2. Evaluation of circulating-tumor DNA (ctDNA; liquid biopsy) yields similar genomic profile as the tumor sample. [ Time Frame: 48 months ]
    To identify potential prognostic and predictive biomarkers based on changes on circulating tumour DNA (ctDNA), detected by molecular biology techniques

  3. Number of patients with recommended therapy according to biological data (liquid versus tumor biopsy) [ Time Frame: 48 months ]
  4. Tumor characteristics using a radiomic approach and detailed analyses of imaging. [ Time Frame: 48 months ]
  5. FACT-G questionnaire [ Time Frame: 48 months ]
    To evaluate the quality of life and emotional distress anxiety/depression over time of patients

  6. HADS questionnaire [ Time Frame: 48 months ]
    To evaluate the quality of life and emotional distress anxiety/depression over time of patients

  7. PRO questionnaire [ Time Frame: 48 months ]
    To evaluate the quality of life and emotional distress anxiety/depression over time of patients

  8. Correlation between patient's understanding and experiences of precision medicine clinical trial [ Time Frame: 48 months ]
    Measured by thematic analysis of semi-structured interviews: themes and sub-themes will be analyzed in order to develop items for the construction and validation of a quantitative questionnaire.

  9. Correlation between socio-spatial inequalities in access to the PLANET program and the impact on the quality of life of patients [ Time Frame: 48 months ]
    Questionnaire

  10. TKI pharmacokinetics [ Time Frame: 48 months ]
    Plasma concentrations of TKI


Eligibility Criteria
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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:

I1. Adult male or female patient with confirmed diagnosis of advanced/metastatic cancer to be treated with standard anti-cancer treatment according to :

  • For metastatic Small cell lung cancer (SLCC) : treatment by Immunotherapy ± chemotherapy
  • For Recurrent/Metastatic Head and Neck squamous cell carcinoma (HNSCC) : treatment by Immunotherapy (all lines) ± chemotherapy if in agreement with SmPC
  • For Metastatic Urothelial carcinoma : treatment by 1st line chemotherapy with avelumab as maintenance treatment (patients will be enrolled following 4 to 6 cycles of CT, only patient initiating avelumab maintenance are eligible (i.e. patients with SD or PR after CT)
  • For MSI-High, any tumor types : treatment by Immunotherapy
  • For HPV-related cancers, any tumor types : treatment by Immunotherapy
  • Metastatic GIST : treatment by Imatinib
  • BRAF- V600E tumors (lung and thyroid cancer) : treatment by Dabrafenib + trametinib
  • BRAF- mutated tumors (CRC, lung and thyroid cancer) :

Lung (V600E only) and thyroid (all BRAF mutation with known sensitivity to Dabrafenib): treatment by Dabrafenib + trametinib CRC (BRAF V600E): treatment by Encorafenib + cetuximab

  • All solid tumor types with ret fusion / mutation : treatment by Selpercatinib
  • Metastatic Triple negative breast cancer (TNBC) : treatment by 1st line chemotherapy
  • Glioblastoma : treatment by Radiochemotherapy
  • Advanced high grade epithelial ovarian cancer : treatment by 1st line Chemotherapy
  • Chronic Lymphocytic Leukemia (CLL) in the relapsed setting : treatment by Bruton Kinase Inhibitors

I2. All solid tumor cohorts: Availability of an archival representative formalin-fixed paraffin-embedded (FFPE) tumor sample [...]

I3. All solid tumor cohorts: Disease evaluable as per RECIST V1.1

I4. All solid tumor cohorts excluding Glioblastoma: Tumor lesion visible by medical imaging and accessible to repeatable percutaneous or endoscopic mandatory de novo tumor sampling [...]

I5. Performance status (PS) ECOG 0 or 1.

I6. 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 including sequential tumor biopsies as per protocol.

I7. Patient must be covered by a medical insurance.

Exclusion Criteria:

NI1. All solid tumor cohorts - Patient with non-acceptable tumor sample at screening.

NI2. Any condition contraindicated with blood/tumor sampling procedures required by the protocol.

NI3. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.

NI4. Pregnant or breast-feeding woman.

Contacts and Locations
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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): NCT05099068


Contacts
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Contact: Pierre SAINTIGNY, MD, PhD 04 69 85 60 05 Pierre.saintigny@lyon.unicancer.fr

Locations
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France
HOPITAL Pierre WERTHEIMER - HCL Not yet recruiting
Bron, France, 69677
Contact: François DUCRAY, MD    04 72 68 13 21    francois.ducray@chu-lyon.fr   
Centre Léon Bérard Recruiting
Lyon, France, 69373
Contact: Pierre SAINTIGNY, MD,PhD    04 69 85 60 05    pierre.saintigny@lyon.unicancer.fr   
Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Pierre SAINTIGNY, MD, PhD Centre Leon Berard
More Information
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT05099068    
Other Study ID Numbers: Plasticity Longitudinal cANcer
First Posted: October 29, 2021    Key Record Dates
Last Update Posted: July 5, 2022
Last Verified: June 2022

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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:
Molecular Screening
Genomic profiles
Transcriptomic profiles
Additional relevant MeSH terms:
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Glioblastoma
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Leukemia
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes