NCT06730672

An Exploratory Study on the Failure of Immunotherapy With Voronib Combined With Everolimus

Efficacy and Safety of Voronib Combined With Everolimus After Immunotherapy Failure in Advanced Renal Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single-arm exploratory study included patients with renal clear cell carcinoma who had previously received one type of immunotherapy and failed. The specific regimen was Voronib 200mg PO.QD combined with everolimus 5mg QD. 80 patients were planned to continue treatment until PD, toxicity became intolerable, patient withdrawal was informed, or medication had to be discontinued. Collect patient medication information and disease efficacy evaluation, adverse reactions. In this study, blood samples were collected 0-4 weeks before treatment, 2 months, 4 months, 6 months, 8 months of drug treatment, and at the time of PD progression for ctDNA detection.

Detailed description

The participant must have received no more than two kinds of tyrosine kinase inhibitors (TKIs) medications (excluding mTOR inhibitors) and one type of immune checkpoint inhibitor treatment, with treatment failure in systemic antitumor therapy. Additionally, the participant must have completed the last systemic antitumor treatment ( chemotherapy,radiotherapy, targeted therapy, biological therapy, or endocrine therapy) at least 3 weeks prior, or at least 5 half-lives since the last systemic antitumor treatment. Furthermore, any treatment-related toxicities must have resolved to meet the laboratory test requirements for this trial.

Conditions

• Renal Cell Carcinoma Stage I

Interventions

Type	Name	Description
DRUG	Volonib combined with Everolimus Formation	Volonib 200mg once daily and Everolimus 5mg once daily

Timeline

• Start date: 2024-12-30
• Primary completion: 2027-12-27
• Completion: 2028-12-27
• First posted: 2024-12-12
• Last updated: 2024-12-18

Locations

2 sites across 1 country: China