Using multiomics to improve treatment for metastatic clear cell renal carcinoma
Multiomics Approach for Patients Stratification and Novel Target Identification in Metastatic Clear Renal Cell Carcnoma
This study is trying to find out how to better choose treatments for patients with advanced clear cell kidney cancer by looking at their blood and imaging results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | radiation, nivolumab, ipilimumab, pembrolizumab, atezolizumab, bevacizumab, avelumab, axitinib, lenvatinib, cabozantinib, sunitinib, immunotherapy |
| Locations | 1 site (Milan, Mi) |
| Trial ID | NCT05782400 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify predictive factors for treatment allocation in treatment-naive patients with metastatic clear cell renal carcinoma (mccRCC). By utilizing non-invasive liquid biopsy methods to analyze circulating cell-free DNA, extracellular vesicle-associated RNAs, and circulating tumor cells, the study seeks to develop tailored treatment strategies. Additionally, it incorporates radiomics to correlate imaging features with tumor characteristics and clinical outcomes. The goal is to integrate genomic and radiomic data through computational approaches, potentially leading to better patient stratification for systemic therapies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed advanced or metastatic clear cell renal carcinoma who have not received prior systemic therapy.
Not a fit: Patients with non-clear cell renal carcinoma or those who have previously undergone systemic therapy for RCC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with metastatic clear cell renal carcinoma.
How similar studies have performed: Other studies utilizing multiomics and radiomics approaches have shown promise in improving treatment outcomes, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA: * Signed Written Informed Consent * Male or female subjects aged ≥18 years old * Histologically confirmed advanced/metastatic RCC with predominantly clear-cell subtype * Previous nephrectomy is permitted * Availability of tumor tissue sample for biomarker analysis * Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC, candidate to receive first-line systemic treatment with monotherapy TKI or IO+TKI or IO+IO * No prior systemic therapy for RCC with the following exception: prior adjuvant therapy for completely resectable RCC (concluded at least 6 months before study entry) * All IMDC risk (good, intermediate, poor) * TC scan performed with and without contrast medium, at baseline (according to protocol guidelines as reported below in Table 1) * At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Eastern Cooperative Oncology Group performance status 0 or 1 * Capable of understanding and complying with the protocol requirements. EXCLUSION CRITERIA: * Any prior systemic treatment for RCC in the advanced/metastatic settings * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways * Previous exposure to tyrosine kinase inhibitors in the advanced/metastatic settings * Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis * Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of the start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low-grade prostate cancer (≤pT2, N0; Gleason 6) with no plans for treatment intervention * Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the start of treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Where this trial is running
Milan, Mi
- Istituto Tumori — Milan, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppe Procopio, MD — Fondazione IRCCS istituto Nazionale dei Tumori di Milano
- Study coordinator: Giuseppe Procopio, MD
- Email: giuseppe.procopio@istitutotumori.mi.it
- Phone: 00390223903813
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.