Multicentric study evaluating the usefulness of early PSMA PET scan in metastatic renal cancer requiring standard immunotherapy treatment.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cliniques Universitaires Saint-Luc

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Decision date (initial)

2025-03-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To evaluate the value of early change in the PSMA expression (highlighted by 68Ga) in the PET/CT in the prediction of anticancer treatment efficacy response in metastatic renal cancer patients, as defined by the Disease Control Rate (DCR) assessed at 6-month.

Secondary objectives 1

1. To evaluate the correlation between change from baseline PSMA expression and anticancer treatment efficacy as defined by the Overall Response Rate (ORR).

Conditions and MedDRA coding

metastatic clear cell Renal Carcinoma Cell

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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

Exclusion criteria 9

1. Non-ccRCC
2. Previous anticancer systemic treatment for metastatic ccRCC
3. 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)
4. 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.
5. Patients treated with other concomitant anticancer therapy.
6. 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.
7. Breastfeeding women are excluded from the trial
8. 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.
9. Patients who received prior radiotherapy within 2 weeks of the first 68Ga-gozetotide dose. Radiation-related toxicities must have resolved.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 Complete response (CR), o Partial response (PR) o Stable disease (SD)) o Patients deceased or lost-of follow-up will be considered as progressive disease (PD). o Patients with a non evaluable assessment will also be categorized as non-responders.

Secondary endpoints 3

1. o Correlation 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)
2. o Correlation between baseline 68Ga-PSMA-PET expression and DCR
3. o Correlation 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.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cliniques Universitaires Saint-Luc

Sponsor organisation

Cliniques Universitaires Saint-Luc

Address

Hippokrateslaan 10, Batiment 54 Batiment 54

City

Sint-Lambrechts-Woluwe

Postcode

1200

Country

Belgium

Scientific contact point

Organisation

Cliniques Universitaires Saint-Luc

Contact name

Dr Emmanuel Seront

Public contact point

Organisation

Cliniques Universitaires Saint-Luc

Contact name

Dr Emmanuel Seront

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

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

Documents 9 files

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

Application history

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