Back to resultsProfiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET) (PLANET)
Primary Purpose
Advanced / Metastic Solid Tumors, Glioblastoma, Chronic Leukemia Lymphocytic
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood and tumor samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Advanced / Metastic Solid Tumors focused on measuring Molecular Screening, Genomic profiles, Transcriptomic profiles
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.
Sites / Locations
- HOPITAL Pierre WERTHEIMER - HCL
- Centre Léon BérardRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
IMMUNOTHERAPY COHORTS
TARGETED THERAPIES COHORTS
CHEMOTHERAPY COHORTS
Arm Description
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
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.
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
Outcomes
Primary Outcome Measures
Number of patients with meaningful molecular genetic alterations on tumor sample
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
Number of patients with meaningful molecular genetic alterations on circulating tumour DNA (ctDNA)
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
Number of patients with meaningful immunological features
Identification and characterisation of the tumor microenvironment and the host's immunological profile, at diagnosis and during patient treatment
Objective Response Rate (ORR) as per RECIST V1.1 and according to central review
For solid tumors excluding glioblastoma only
Progression-Free Survival (PFS)
For glioblastoma only
Objective Response Rate (ORR) according to iwCLL criteria
For chronic lymphocytic leukemia
Secondary Outcome Measures
Correlation between disease evolution and molecular and/or immunological biomarkers
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
Evaluation of circulating-tumor DNA (ctDNA; liquid biopsy) yields similar genomic profile as the tumor sample.
To identify potential prognostic and predictive biomarkers based on changes on circulating tumour DNA (ctDNA), detected by molecular biology techniques
Number of patients with recommended therapy according to biological data (liquid versus tumor biopsy)
Tumor characteristics using a radiomic approach and detailed analyses of imaging.
FACT-G questionnaire
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
HADS questionnaire
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
PRO questionnaire
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
Correlation between patient's understanding and experiences of precision medicine clinical trial
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.
Correlation between socio-spatial inequalities in access to the PLANET program and the impact on the quality of life of patients
Questionnaire
TKI pharmacokinetics
Plasma concentrations of TKI
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05099068
Brief Title
Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET)
Acronym
PLANET
Official Title
A Prospective Longitudinal Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
September 15, 2025 (Anticipated)
Study Completion Date
September 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced / Metastic Solid Tumors, Glioblastoma, Chronic Leukemia Lymphocytic
Keywords
Molecular Screening, Genomic profiles, Transcriptomic profiles
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IMMUNOTHERAPY COHORTS
Arm Type
Experimental
Arm Description
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
Arm Title
TARGETED THERAPIES COHORTS
Arm Type
Experimental
Arm Description
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.
Arm Title
CHEMOTHERAPY COHORTS
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Blood and tumor samples
Intervention Description
Longitudinal molecular profiling of tumor and liquid biopsies.
Primary Outcome Measure Information:
Title
Number of patients with meaningful molecular genetic alterations on tumor sample
Description
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
Time Frame
At the end of study (4 years)
Title
Number of patients with meaningful molecular genetic alterations on circulating tumour DNA (ctDNA)
Description
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
Time Frame
At the end of study (4 years)
Title
Number of patients with meaningful immunological features
Description
Identification and characterisation of the tumor microenvironment and the host's immunological profile, at diagnosis and during patient treatment
Time Frame
At the end of study (4 years)
Title
Objective Response Rate (ORR) as per RECIST V1.1 and according to central review
Description
For solid tumors excluding glioblastoma only
Time Frame
3 months
Title
Progression-Free Survival (PFS)
Description
For glioblastoma only
Time Frame
6 months
Title
Objective Response Rate (ORR) according to iwCLL criteria
Description
For chronic lymphocytic leukemia
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Correlation between disease evolution and molecular and/or immunological biomarkers
Description
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
Time Frame
Time Frame: up to 4 years
Title
Evaluation of circulating-tumor DNA (ctDNA; liquid biopsy) yields similar genomic profile as the tumor sample.
Description
To identify potential prognostic and predictive biomarkers based on changes on circulating tumour DNA (ctDNA), detected by molecular biology techniques
Time Frame
48 months
Title
Number of patients with recommended therapy according to biological data (liquid versus tumor biopsy)
Time Frame
48 months
Title
Tumor characteristics using a radiomic approach and detailed analyses of imaging.
Time Frame
48 months
Title
FACT-G questionnaire
Description
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
Time Frame
48 months
Title
HADS questionnaire
Description
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
Time Frame
48 months
Title
PRO questionnaire
Description
To evaluate the quality of life and emotional distress anxiety/depression over time of patients
Time Frame
48 months
Title
Correlation between patient's understanding and experiences of precision medicine clinical trial
Description
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.
Time Frame
48 months
Title
Correlation between socio-spatial inequalities in access to the PLANET program and the impact on the quality of life of patients
Description
Questionnaire
Time Frame
48 months
Title
TKI pharmacokinetics
Description
Plasma concentrations of TKI
Time Frame
48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre SAINTIGNY, MD, PhD
Phone
04 69 85 60 05
Email
Pierre.saintigny@lyon.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre SAINTIGNY, MD, PhD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOPITAL Pierre WERTHEIMER - HCL
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François DUCRAY, MD
Phone
04 72 68 13 21
Email
francois.ducray@chu-lyon.fr
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre SAINTIGNY, MD,PhD
Phone
04 69 85 60 05
Email
pierre.saintigny@lyon.unicancer.fr
12. IPD Sharing Statement
Learn more about this trial
Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET)
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