Cabozantinib for Clear cell renal cell carcinoma | Renal cell carcinoma

Inclusion criteria

• {"criterion_text":"- Patients ≥ 70 years-old"}
• {"criterion_text":"- Confirmed advanced or clear-cell metastatic renal-cell carcinoma"}
• {"criterion_text":"- Patients not previously treated in metastatic setting"}
• {"criterion_text":"- Performance Status 0 to 2"}
• {"criterion_text":"- Sexually active male patients must agree to use condom during the study and for at least 5 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception"}
• {"criterion_text":"- Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol."}
• {"criterion_text":"- Patients must be affiliated to a social security system or beneficiary of the same"}

Exclusion criteria

• {"criterion_text":"- Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (Patients may be included in CABOLD if they are included in the arm B of CARE1 study EUCT N° 2023-503317-29-00)"}
• {"criterion_text":"- Performance Status > 2"}
• {"criterion_text":"- Any condition that represent a contraindication to Cabozantinib and/or Nivolumab as described in summaries of products characteristics, including symptomatic untreated brain metastasis or active auto-immune disease requiring systemic immunosuppressant/modulator (thyroid or adrenal disorder are not an exclusion criteria)"}
• {"criterion_text":"- Any severe cardiovascular or thrombo-embolic event in the last three months"}
• {"criterion_text":"- Any situation for which exclusive palliative care intervention is recommended"}
• {"criterion_text":"- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent"}
• {"criterion_text":"- Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (except: patients Version 1.0 02/10/24 Confidential Page 6 of 68 included in CARE1 may be included in CABOLD if they are included in the arm B of CARE1 study (EUCT N° 2023-503317-29-00))"}

Primary endpoints

• {"endpoint_text":"- Treatment patterns, including starting dose of Cabozantinib, dose interruption, dose modification related to all grade toxicity at 24 weeks.","definition_or_measurement_approach":"Assessment at 24 weeks of treatment patterns: starting dose of cabozantinib, occurrence of dose interruptions and dose modifications related to all-grade toxicity."}

Secondary endpoints

• {"endpoint_text":"- Overall response rate based on radiological evaluation","definition_or_measurement_approach":"Radiological assessments to determine overall response rate (per imaging-based tumour response criteria)."}
• {"endpoint_text":"- Overall-survival","definition_or_measurement_approach":"Time from study entry to death from any cause (overall survival)."}
• {"endpoint_text":"- Progression free survival","definition_or_measurement_approach":"Time from study entry to radiological or clinical progression or death (progression-free survival)."}
• {"endpoint_text":"- Duration of response","definition_or_measurement_approach":"Time from first documented response to progression or death (duration of response)."}
• {"endpoint_text":"- Tolerance based on physicians and patients reports","definition_or_measurement_approach":"Physician- and patient-reported assessments of tolerability (toxicity reports, adverse events reporting)."}
• {"endpoint_text":"- Unplanned hospitalizations, emergency departments visits and falls","definition_or_measurement_approach":"Collection of healthcare utilisation events: unplanned hospitalisations, ED visits, and recorded falls."}
• {"endpoint_text":"- Patients reported quality of life (FACT-G and FACIT-TS-G),","definition_or_measurement_approach":"Patient-reported outcome instruments FACT-G and FACIT-TS-G to assess quality of life."}
• {"endpoint_text":"- Exploratory analyses to assess potential associations between G-CODE parameters and pharmacological monitoring of Cabozantinib with safety, efficacy, and QoL criteria","definition_or_measurement_approach":"Exploratory statistical analyses correlating G-CODE parameters and pharmacologic monitoring data of cabozantinib with safety, efficacy and QoL outcomes."}

Other endpoints

• {"endpoint_text":"- Exploratory analyses to assess potential associations between G-CODE parameters and pharmacological monitoring of Cabozantinib with safety, efficacy, and QoL criteria","definition_or_measurement_approach":"Exploratory correlation analyses between G-CODE parameters, cabozantinib pharmacological monitoring and safety/efficacy/QoL endpoints."}

France

Earliest CTIS Part Ii Submission Date

23-01-2025

Latest Decision Or Authorization Date

12-11-2025

Processing Time Days

293

Number Of Sites

11

Number Of Participants

50

Primary sponsor

Full Name

Institut Gustave Roussy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France