CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Pembrolizumab plus Lenvatinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05485896
NCT05485896Phase 2Completed
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A Prospective Single-arm Clinical Study of Pembrolizumab Combined With Lenvatinib Neoadjuvant Therapy in Patients With Advanced Renal Cell Carcinoma

Tianjin Medical University Second Hospital·interventional·Posted Aug 3, 2022·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab plus Lenvatinib for Renal Cell Carcinoma. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedAug 3, 2022
Enrollment StartJul 1, 2022
Primary CompletionDec 31, 2023
Study CompletionSep 2, 2024
TodayJul 1, 2026
Enrollment to primary: 1.5 yearsPosted 3.9 years ago

Interventions

Pembrolizumab plus Lenvatinibdrug

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).