PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJinling Hospital, China
About this trial
This phase 2 trial aims to test the feasibility and efficiency of PET/CT-directed treatment interruption strategy in metastatic renal cell carcinoma patients with IMDC favorable/intermediate risk who achieve complete (CMR) or partial metabolic response (PMR) after ≥12 months of first-line PD-1/PD-L1 Immune checkpoint inhibitor (ICI)+ VEGFR-tyrosine kinase inhibitor (TKI) therapy. It helps figure out whether PET/CT can safely direct treatment pause as well as explores a new individualized treatment option based on metabolic imaging for RCC patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects aged ≥ 18 years at time of signing informed consent
Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer [AJCC] Stage IV)
Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
Eastern Cooperative Oncology Group performance status 0 or 1
Disqualifiers
Highly malignant pathology
Prior systemic therapy for advanced RCC
Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
ECOG performance status >1
Trial design
Design model
Single group
Treatments tested in this trial
Intermittent PD-1/PD-L1 ICI + VEGFR-TKI
DrugAny PD-1/PD-L1 inhibitor or VEGFR-TKI that is commercially marketed, regulatory-approved and reimbursed under public health plans.Dose as recommended by the manufacturer.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Treatment pauseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS) rate
Proportion of participants alive and without disease progression at 24 months will be assessed according to PERCIST 1.0 criteria.
Time frame
24 months from treatment initiationSecondary outcomes
1
Duration of response (DoR)
Time from first documented complete metabolic response (CMR) or partial metabolic response (PMR) to disease progression or death.
Time frame
From treatment interruption until disease progression or death, assessed up to 24 months2
Overall survival (OS)
Time from date of enrollment to date of death due to any cause.
Time frame
From treatment initiation until death from any cause, assessed up to 5 years3
Progression free survival (PFS)
Time from first study drug administration to first documented objective disease progression (PD) or death, whichever occurs first.
Time frame
From treatment initiation until disease progression or death from any cause, assessed up to 5 years4
Overall safety profile
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 criteria.
Time frame
From the date of the first study drugs administration up to 90 days after the last dose of study drugs administrationOther outcomes
1
Metabolic response assessed by serial PET/CT
Metabolic response and changes of FDG-uptake values on serial PET/CT during this trial will be assessed and documented.
Time frame
Baseline to 24 months from treatment initiation2
Biobanking for future research
Collection of serial peripheral blood samples and other biologic specimens during the trial for subsequent exploratory biomarker studies.
Time frame
Baseline to 24 months from treatment initiationSponsors and contacts
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Source ClinicalTrials.gov