Trial reportEuropean urology2024
Characterization of Responses to Lenvatinib plus Pembrolizumab in Patients with Advanced Renal Cell Carcinoma at the Final Prespecified Survival Analysis of the Phase 3 CLEAR Study.
Trial report in European urology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02811861 (A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects With Advanced Renal Cell Carcinoma), which is not on this map. Cited by 12 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects With Advanced Renal Cell Carcinoma (CLEAR)
Who cites it
12 citing papers in PubMed, 11 citations in OpenAlex.
- Pembrolizumab plus high-dose IL-2 in advanced clear cell renal cell carcinoma: six-year survival outcomes and molecular signatures from a phase 2 trial.Nature communications · 2026Trial
- Real-World Comparison of Dual Checkpoint Blockade and Immunotherapy Plus TKIs in Metastatic RCC.Cancer medicine · 2026Observational
- Prognostic significance of early tumor shrinkage in metastatic renal cell carcinoma treated with first-line immune checkpoint inhibitor-based combination therapy.International journal of clinical oncology · 2026Article
- Prognostic Impact of DPP4 Inhibitors on Systemic Drug Therapy for Advanced Kidney Cancer Patients.Cancer science · 2026Article
- Hong Kong Urological Association-Hong Kong Society of Uro-Oncology 2025 consensus on the management of locally advanced or metastatic renal cell carcinoma.Frontiers in oncology · 2026Review
- Real-world efficacy and safety of pembrolizumab plus lenvatinib in patients with metastatic renal cell carcinoma: a multi-institutional retrospective study.Scientific reports · 2025Article
- Efficacy and safety of combination immunotherapy for treating advanced non-clear cell renal cell carcinoma: A multicenter retrospective study in Japan.Scientific reports · 2025Observational
- Harnessing the power of combination therapy: reflecting on the final survival data from the CLEAR study with lenvatinib plus pembrolizumab.Translational andrology and urology · 2025Article
- Metastatic renal cell carcinoma disease response in the era of immune checkpoint inhibitor-based combinations.Translational andrology and urology · 2025Article
- Pembrolizumab plus Lenvatinib in patients with metastatic Renal Cell Carcinoma: real-world evidences from the international ARON- 1 study.Cancer immunology, immunotherapy : CII · 2025Article
- Efficacy and safety of lenvatinib and pembrolizumab as first-line treatment for advanced renal cell carcinoma patients: real-world experience in Japan.International journal of clinical oncology · 2024Article
- IdentifyingTranslational andrology and urology · 2024Article
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Authors and funding
18 authors at 17 institutions in 8 countries.
Funding
Abstract
In the phase 3 CLEAR trial, lenvatinib plus pembrolizumab (L + P) showed superior efficacy versus sunitinib in treatment-naïve patients with advanced renal cell carcinoma (aRCC). The combination treatment was associated with a robust objective response rate of 71%. Here we report tumor responses for patients in the L + P arm in CLEAR, with median follow-up of ∼4 yr at the final prespecified overall survival (OS) analysis. Tumor responses were assessed by independent review using Response Evaluation Criteria in Solid Tumors v1.1. Patients with a complete response (CR; n = 65), partial response (PR) with maximum tumor shrinkage ≥75% (near-CR; n = 59), or PR with maximum tumor shrinkage <75% (other PR; n = 129), were characterized in terms of their baseline characteristics. The median duration of response was 43.7 mo (95% confidence interval [CI] 39.2-not estimable) for the CR group, 30.5 mo (95% CI 22.4-not estimable) for the near-CR group, and 17.2 mo (95% CI 12.5-21.4) for the other PR group. The 36-mo OS rates were consistently high in the CR (97%), near-CR (86%), and other PR (62%) groups. Robust objective response rates were observed across International Metastatic RCC Database Consortium favorable-risk (69%, 95% CI 60-78%), intermediate-risk (73%, 95% CI 67-79%), and poor-risk (70%, 95% CI 54-85%) subgroups. The robust response to L + P supports this combination as a standard-of-care first-line treatment for patients with aRCC. PATIENT SUMMARY: The CLEAR trial enrolled patients with advanced kidney cancer who had not previously received any treatment for their cancer. Here we report results for tumor shrinkage observed in the group that received lenvatinib plus pembrolizumab combination treatment during the trial. Shrinkage of target tumors with this combination was long-lasting and was observed in patients irrespective of their disease severity. This trial is registered on ClinicalTrials.gov as NCT02811861.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.