Trial reportCancer research communications2026
Lenvatinib plus Pembrolizumab for Patients with Previously Treated Advanced Gastric, Biliary Tract, or Pancreatic Cancer: Results from the Phase II LEAP-005 Study.
Trial report in Cancer research communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03797326 (A Multicenter, Open-label Phase 2 Study of Lenvatinib), which is not on this map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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 Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)
Who cites it
5 citing papers in PubMed.
- Review
- The Evolving Landscape of Immune Regulation and Immunotherapy in Cholangiocarcinoma and Biliary Tract Cancer.Cancers · 2026Review
- [Immunotherapy and Targeted Therapy for Advanced Biliary Tract Cancer].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2026Review
- Transarterial infusion chemotherapy combined with lenvatinib and tislelizumab versus intravenous chemotherapy for unresectable pancreatic ductal adenocarcinoma: a retrospective propensity score matching analysis.Frontiers in oncology · 2026Article
- Metachronous hepatocellular carcinoma after partial response of advanced intrahepatic cholangiocarcinoma treated with radiotherapy combined with apatinib and camrelizumab: a case report.Frontiers in oncology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
Abstract
purposePatients with gastric cancer, biliary tract cancer (BTC), and pancreatic ductal adenocarcinoma (PDAC) have poor survival outcomes and limited second- or later-line treatment options. Certain drugs targeting vascular endothelial growth factor (VEGF) or programmed cell death protein 1 (PD-1) signaling pathways are currently used in these cancers in specific circumstances; however, there remains a need for novel treatment combinations. LEAP-005 is a multicohort, open-label, phase II study that evaluated lenvatinib (multitargeted inhibitor of tyrosine kinases, including VEGF) plus pembrolizumab (anti-PD-1 monoclonal antibody) in select previously treated solid tumors. PATIENTS AND
methodsParticipants with previously treated, advanced gastric cancer, BTC, and PDAC were enrolled in cohorts C, F, and G of LEAP-005, respectively, and received lenvatinib 20 mg/day orally plus pembrolizumab 200 mg i.v. every 3 weeks. Primary endpoints were objective response rate (ORR) and safety.
resultsOf 99, 102, and 103 total participants enrolled in cohorts C, F, and G, respectively, median times from first dose of study treatment to data cutoff (February 6, 2023) were 23.7, 24.2, and 19.5 months. ORRs (95% confidence interval) by blinded independent central review were 15.2% (8.7%-23.8%) in cohort C, 17.6% (10.8%-26.4%) in cohort F, and 7.8% (3.4%-14.7%) in cohort G. Grade 3 to 5 treatment-related adverse events occurred in 54.5% of participants in cohort C, and grade 3 to 4 (no grade 5) occurred in 60.8% and 59.2% of participants in cohorts F and G, respectively.
conclusionsLenvatinib plus pembrolizumab demonstrated modest antitumor activity and a manageable safety profile in previously treated, advanced gastric cancer, BTC, and PDAC. SIGNIFICANCE: In the phase II LEAP-005 study, lenvatinib plus pembrolizumab showed modest antitumor activity and a manageable safety profile in participants with previously treated gastrointestinal-related cancers. Exploratory analyses in participants with BTC indicated higher ORRs in participants with targetable alterations versus those without.
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