✓ Translated by DotMD AI Clinical Council Source: European urology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #37778952 ↗

Phase III Randomized Trial: Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011) (N = 245)

Original Paper Title: “Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011): A Phase 3, Randomized, Double-Blind Trial”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
N = 245
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • The benefit-to-risk ratio for first-line lenvatinib plus pembrolizumab was not considered favorable versus pembrolizumab plus placebo as first-line therapy in patients with advanced UC.
  • Study Design & Sample: Phase III Randomized Trial published in European urology (N = 245 human participants).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in European urology (2024), this phase iii randomized trial evaluating 245 human participants investigated: Pembrolizumab plus lenvatinib has shown antitumor activity and acceptable safety in patients with platinum-refractory urothelial carcinoma (UC). Key clinical takeaway: The benefit-to-risk ratio for first-line lenvatinib plus pembrolizumab was not considered favorable versus pembrolizumab plus placebo as first-line therapy in patients with advanced UC.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (European urology, 2024-03-15; N = 245; Rigor 88/100): The benefit-to-risk ratio for first-line lenvatinib plus pembrolizumab was not considered favorable versus pembrolizumab plus placebo as first-line therapy in patients with advanced UC.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about PMID 37778952: Phase III Randomized Trial: Pembrolizumab with or Without Lenvatinib as First-line Therapy for Patients with Advanced Urothelial Carcinoma (LEAP-011) (N = 245)

3 of 3 Free Questions Remaining