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

  • STATUS
    Recruiting
  • End date
    Sep 15, 2025
  • participants needed
    500
  • sponsor
    Centre Leon Berard
Updated on 4 October 2022
cancer
chronic lymphocytic leukemia
BRAF
RET
cancer treatment

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.

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.

Details
Condition Advanced / Metastic Solid Tumors, Glioblastoma, Chronic Leukemia Lymphocytic
Treatment Blood and tumor samples
Clinical Study IdentifierNCT05099068
SponsorCentre Leon Berard
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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 MSI-High, any tumor types : treatment by Immunotherapy
For Metastatic Urothelial carcinoma : treatment by 1st line chemotherapy with avelumab
For HPV-related cancers, any tumor types : treatment by Immunotherapy
as maintenance treatment (patients will be enrolled following 4 to 6 cycles of CT
Metastatic GIST : treatment by Imatinib
only patient initiating avelumab maintenance are eligible (i.e. patients with SD or PR
after CT)
BRAF- V600E tumors (lung and thyroid cancer) : treatment by Dabrafenib + trametinib
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
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
I3. All solid tumor cohorts: Disease evaluable as per RECIST V1.1
Chronic Lymphocytic Leukemia (CLL) in the relapsed setting : treatment by Bruton
Kinase Inhibitors
I5. Performance status (PS) ECOG 0 or 1
I2. All solid tumor cohorts: Availability of an archival representative formalin-fixed
I6. Patient should understand, sign, and date the written ICF prior to any
paraffin-embedded (FFPE) tumor sample [...]
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
I7. Patient must be covered by a medical insurance
[...]
protocol-specific procedures performed. Patient should be able and willing to comply with
study visits and procedures including sequential tumor biopsies as per protocol

Exclusion Criteria

NI1. All solid tumor cohorts - Patient with non-acceptable tumor sample at screening
NI4. Pregnant or breast-feeding woman
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
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