GOZETOTIDE for Metastatic clear cell renal cell carcinoma

Inclusion criteria

• {"criterion_text":"-Adult patients (>18 years), male or female\n-Histologically proven clear cell Renal Carcinoma Cell (ccRCC). Sarcomatoid component is allowed\n-Patient eligible for ICI + ICI combination or ICI + TKI combination\n-Patient with expected survival of at least 6 months\n-Patients with PSMA positive lesions on PSMA-PET/CT (which is expected to be found in 90% of patients)\n-Patients able to consent\n-Metastatic ccRCC"}

Exclusion criteria

• {"criterion_text":"-Non-ccRCC\n-Previous anticancer systemic treatment for metastatic ccRCC\n-Concurrent malignancy or previous malignancy in the last 3 years prior to start the study (with the exception of a history of adequately treated cervical carcinoma in situ or non-melanoma skin cancer)\n-Patient with active uncontrolled or symptomatic central nervous system (CNS metastases). Patients treated previously with radiotherapy and/or surgery resulting in controlled/asymptomatic CNS disease are allowed. Controlled/asymptomatic CNS disease is defined as radiological stable without evidence of progression for at least 4 weeks by repeat imaging performed prior to first dose of 68Ga-gozetotide and clinically stable without requirement of steroid treatment for at least 2 weeks prior to first dose of study treatment.\n-Patients treated with other concomitant anticancer therapy.\n-Pregnancy must be excluded and a pregnancy test must be done within 72 hours before each administration of 68Ga-gozetotide for women of childbearing potential.\n-Breastfeeding women are excluded from the trial\n-Patients with a hypersensitivity to the active substance of 68Ga-PSMA-11 or to one of its excipients as described in the SmPC of Locametz.\n-Patients who received prior radiotherapy within 2 weeks of the first 68Ga-gozetotide dose. Radiation-related toxicities must have resolved."}

Primary endpoints

• {"endpoint_text":"-Correlation between the change in expression of PSMA expression between baseline and 6-week timepoint and the 6-month Disease Control Rate on anticancer treatment (ICI + TKI or ICI + ICI). The DCR is defined as the number of patients with o\tComplete response (CR), o\tPartial response (PR) o\tStable disease (SD)) o\tPatients deceased or lost-of follow-up will be considered as progressive disease (PD). o\tPatients with a non evaluable assessment will also be categorized as non-responders.","definition_or_measurement_approach":"Correlation of change in PSMA expression (baseline vs 6 weeks on PSMA-PET/CT) with 6-month Disease Control Rate (DCR) on anticancer treatment (ICI+TKI or ICI+ICI). DCR is defined as number of patients with Complete Response (CR), Partial Response (PR) or Stable Disease (SD). Patients deceased or lost to follow-up will be considered progressive disease (PD). Patients with non-evaluable assessment will be categorized as non-responders."}

Secondary endpoints

• {"endpoint_text":"-o\tCorrelation between the change in expression of PSMA on PSMA-PET/CT performed 6-weeks after anticancer treatment initiation and Objective Response Rate (ORR, defined as number of patients with CR and PR)","definition_or_measurement_approach":"Correlation of 6-week change in PSMA expression on PSMA-PET/CT with Objective Response Rate (ORR). ORR defined as number of patients with Complete Response (CR) and Partial Response (PR)."}
• {"endpoint_text":"-o\tCorrelation between baseline 68Ga-PSMA-PET expression and DCR","definition_or_measurement_approach":"Correlation between baseline 68Ga-PSMA-PET expression and 6-month Disease Control Rate (DCR)."}
• {"endpoint_text":"-o\tCorrelation between the change in expression of PSMA on PSMA PET/CT performed 6-weeks after anticancer treatment initiation and Progression-free survival (PFS) calculated as the time from the treatment start to disease progression, death, or last follow-up.","definition_or_measurement_approach":"Correlation of 6-week change in PSMA expression with Progression-Free Survival (PFS). PFS calculated as time from treatment start to disease progression, death, or last follow-up."}

Belgium

Earliest CTIS Part Ii Submission Date

26-02-2025

Latest Decision Or Authorization Date

22-08-2025

Processing Time Days

177

Number Of Sites

3

Number Of Participants

75

Primary sponsor

Full Name

Cliniques Universitaires Saint-Luc

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium