NCT07460206

Pembrolizumab Plus Lenvatinib in REcurrent ccRCC Patients Failing permbroLizUmab aDjuvant trEatment

Pembrolizumab Plus Lenvatinib in REcurrent ccRCC Patients Failing permbroLizUmab aDjuvant trEatment - PRELUDE Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being performed as a single-arm open-label study in order to provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with advanced ccRCC who have progressed on Pembrolizumab as their prior therapy in the adjuvant RCC setting.

Detailed description

There is currently no well-recognized treatment paradigm for patients with advanced RCC who have progressed during or after Pembrolizumab in adjuvant setting. In addition, it is critical to understand whether immunotherapy can be used again after progression. The data from this study will provide additional information on the potential efficacy and safety of the combination treatment in participants specifically after receiving Pembrolizumab in adjuvant setting. A single-arm design was chosen, as there is no globally accepted standard-of-care regimen for participants with mRCC previously treated with adjuvant Pembrolizumab and relapsing within 12 months from last dose.

Conditions

• ccRCC

Interventions

Type	Name	Description
DRUG	Pembrolizumab 200 mg Q3W	The planned dose of pembrolizumab for this study is 200 mg IV every 3 weeks (Q3W). Pembrolizumab will be given for a maximum of 2 years i.e. a total of 35 cycles. Participants who complete study intervention after 2 years of pembrolizumab are eligible for up to 1 year of additional pembrolizumab (second course) upon experiencing disease progression
DRUG	Lenvatinib 20mg QD	The planned dose of Lenvatinib for this study is 20 mg once daily (QD). Lenvatinib will be taken orally until confirmed disease progression or intolerable adverse event(s).

Timeline

• Start date: 2026-08-01
• Primary completion: 2031-08-01
• Completion: 2031-12-01
• First posted: 2026-03-10
• Last updated: 2026-03-10