Radiopharmaceutical treatment of advanced kidney cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

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

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

25 Feb 2026 → ongoing

Decision date (initial)

2025-08-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Advanced Accelerator Applications International S.A (ADACAP), a Novartis Company

External identifiers

EU CT number

2024-517899-38-00

ClinicalTrials.gov

NCT06783348

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Efficacy, Therapy, Safety

The primary objective is to evaluate the activity of 177Lu-PSMA-617 through Objective Response in metastatic ccRCC patients progressing on or after treatment with one ICI, and one VEGFR-TKI, either in combination or in sequence.

Secondary objectives 3

1. To assess the safety profile of 177Lu -PSMA-617 in patients with metastatic ccRCC
2. To estimate disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) of participants with metastatic ccRCC treated with 177Lu-PSMA-617
3. To estimate the time to start subsequent systemic treatment for patients with metastatic ccRCC treated with 177Lu-PSMA-617.

Conditions and MedDRA coding

Clear Cell Renal Cell Carcinoma (ccRCC)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Histologically proven ccRCC. Sarcomatoid component is allowed.
2. Written pre-screening informed consent according to ICH/GCP and local regulations.
3. Adult patients ≥18 years old.
4. 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.
5. 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.
6. Measurable disease by RECIST 1.1 criteria
7. 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).
8. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
9. Before patient 's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion criteria 5

1. Patient with RCC in a single kidney.
2. 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.
3. Other malignancy that is expected to interfere with the treatment or results of this study, such as prostate cancer.
4. Patient with active uncontrolled or symptomatic central nervous system (CNS metastases).
5. Patients treated previously with radiotherapy and/or surgery resulting in controlled/asymptomatic CNS disease are allowed.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective Response, defined as Complete Response (CR) or Partial Response (PR) based on RECIST 1.1 criteria, on conventional imaging.

Secondary endpoints 5

1. Safety in all treated patients using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
2. DCR at 6 months
3. PFS
4. Time to start of next systemic treatment
5. OS

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

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

Sponsor organisation

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

Address

Emmanuel Mounierlaan 83 Bus 11

City

Sint-Lambrechts-Woluwe

Postcode

1200

Country

Belgium

Scientific contact point

Organisation

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

Contact name

Stéphanie Kromar

Public contact point

Organisation

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

Contact name

Vassilis Golfinopoulos

Third parties 1

Locations

3 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 34 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications