Official Title
A Prospective Longitudinal Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies
Brief Title
Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET)
Protocol ID
NCT05099068
Lead Sponsor
Centre Leon Berard
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.
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 Period
-
Enrollment Count
500 participants
Eligibility 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.
Filters
Advanced / Metastic Solid Tumors
Glioblastoma
Chronic Leukemia Lymphocytic
NA
UNKNOWN
ADULT
OLDER_ADULT