NCT05485896

Neoadjuvant Therapy of Pembrolizumab Plus Lenvatinib in Advanced RCC

A Prospective Single-arm Clinical Study of Pembrolizumab Combined With Lenvatinib Neoadjuvant Therapy in Patients With Advanced Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer. Further evaluate whether the treatment plan is beneficial to the patient's surgery.

Detailed description

This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment is beneficial to operation. Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation. Additional 17 cycles of Pembrolizumab were needed for patients with high risk of recurrence (tumor stage 2 with nuclear grade IV or sarcomatoid differentiation, tumor stage 3 or higher, regional lymph-node metastasis, or stage M1 with no evidence of disease residual).

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab plus Lenvatinib	Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation. Additional 17 cycles of Pembrolizumab were needed for patients with high risk of recurrence (tumor stage 2 with nuclear grade IV or sarcomatoid differentiation, tumor stage 3 or higher, regional lymph-node metastasis, or stage M1 with no evidence of disease residual).

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-12-31
• Completion: 2024-09-02
• First posted: 2022-08-03
• Last updated: 2024-09-19

Locations

1 site across 1 country: China