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

Launched by CENTRE LEON BERARD · Oct 18, 2021

Keywords

ClinConnect Summary

The PLANET trial is a research study designed to better understand advanced cancer types, such as metastatic solid tumors, glioblastoma, and chronic lymphocytic leukemia. Researchers will collect samples from both tumor tissue and blood (called liquid biopsies) over time to analyze the cancer's characteristics and how it responds to treatment. This information aims to help doctors predict how well different treatments might work for patients and potentially offer personalized treatment options if a patient’s cancer worsens.

To participate in this study, you must be an adult with a confirmed diagnosis of advanced cancer that requires standard treatment. This includes specific types of cancer that are treated with chemotherapy, immunotherapy, or targeted therapies. Participants will need to provide tumor samples and agree to undergo follow-up procedures, including additional biopsies. The study is currently recruiting patients, and all participants will be closely monitored throughout the process to gather important data that could improve future cancer care.

Gender

ALL

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.