lutetium (177Lu) vipivotide tetraxetan for Clear cell renal cell carcinoma

Inclusion criteria

• {"criterion_text":"- Histologically proven ccRCC. Sarcomatoid component is allowed.\n- Written pre-screening informed consent according to ICH/GCP and local regulations.\n- Adult patients ≥18 years old.\n- Has progressed on or after ≥1-line prior systemic therapy approved in the metastatic setting. Prior treatment must include an antiprogrammed death-1 (receptor) [PD-1]/programmed death-ligand 1 (PD-L1) therapy +/- ipilimumab and a VEGFR-TKI.\n- Patients with at least one PSMA-positive metastatic lesion, and no exclusionary PSMA-negative lesions, with positive lesions defined as those with maximum standardized uptake values (SUVmax) greater than mean standardized uptake values (SUVmean) of liver background.\n- Measurable disease by RECIST 1.1 criteria\n- Patients with adequate blood tests (Absolute neutrophil count > 1.5 x 109/L, Hemoglobin > 9.0 g/dL, Platelet count > 100,000/μL, estimated glomerular filtration rate (GFR) ≥ 40 ml/min by CKDEPI formula, total bilirubin ≤ 1.5 x ULN. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases).\n- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n- Before patient 's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations."}

Exclusion criteria

• {"criterion_text":"- Patient with RCC in a single kidney.\n- Patients with PSMA-negative lesions (defined as PSMA uptake equal to or lower than that of liver parenchyma) in any lymph node with a short axis of at least 15 mm, in any metastatic solid-organ lesions with a short axis of at least 1.0 cm, or in any metastatic bone lesion with a soft-tissue component of at least 1.0 cm in the short axis. Patients with any PSMA-negative metastatic lesion meeting these criteria were ineligible.\n- Other malignancy that is expected to interfere with the treatment or results of this study, such as prostate cancer.\n- Patient with active uncontrolled or symptomatic central nervous system (CNS metastases).\n- Patients treated previously with radiotherapy and/or surgery resulting in controlled/asymptomatic CNS disease are allowed."}

Primary endpoints

• {"endpoint_text":"- Objective Response, defined as Complete Response (CR) or Partial Response (PR) based on RECIST 1.1 criteria, on conventional imaging.","definition_or_measurement_approach":"Objective Response defined as CR or PR according to RECIST 1.1 on conventional imaging."}

Secondary endpoints

• {"endpoint_text":"- Safety in all treated patients using Common Terminology Criteria for Adverse Events (CTCAE) V5.0","definition_or_measurement_approach":"Safety assessed using CTCAE v5.0 in all treated patients."}
• {"endpoint_text":"- DCR at 6 months","definition_or_measurement_approach":"Disease control rate measured at 6 months (DCR at 6 months)."}
• {"endpoint_text":"- PFS","definition_or_measurement_approach":"Progression-free survival (PFS) as a time-to-event endpoint (definition per protocol; RECIST 1.1 used for response assessment)."}
• {"endpoint_text":"- Time to start of next systemic treatment","definition_or_measurement_approach":"Time from treatment (or defined index date) to initiation of next systemic anti-cancer therapy."}
• {"endpoint_text":"- OS","definition_or_measurement_approach":"Overall survival (OS) as time from treatment (or defined index date) to death from any cause."}

France

Earliest CTIS Part Ii Submission Date

29-07-2025

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

213

Number Of Sites

3

Number Of Participants

15

Belgium

Earliest CTIS Part Ii Submission Date

07-08-2025

Latest Decision Or Authorization Date

19-03-2026

Processing Time Days

224

Number Of Sites

5

Number Of Participants

27

Spain

Earliest CTIS Part Ii Submission Date

05-08-2025

Latest Decision Or Authorization Date

04-03-2026

Processing Time Days

211

Number Of Sites

3

Number Of Participants

16

Primary sponsor

Full Name

Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi

Organisation Type

Patient organisation/association

Country Of Registered Address

Belgium

Contract research organisations

Name

TrialPEX

Responsibilities

Reimbursement of patients travel costs in France; contact and management support as listed in third-party entry

Third parties

• {"country":"France","full_name":"TrialPEX","duties_or_roles":"Reimbursement of patients travel costs in France","organisation_type":"Industry"}
• {"country":"","full_name":"Advanced Accelerator Applications International S.A (ADACAP), a Novartis Company","duties_or_roles":"Monetary support","organisation_type":""}