{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T13:08:40Z","timestamp":1790428120225,"version":"4.1.0"},"reference-count":32,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"11","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2020,4,10]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Modulation of vascular endothelial growth factor\u2013mediated immune suppression via angiogenesis inhibition may augment the activity of immune checkpoint inhibitors. We report results from the dose-finding and initial phase II expansion of a phase Ib\/II study of lenvatinib plus pembrolizumab in patients with selected advanced solid tumors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>\n                      Eligible patients had metastatic renal cell carcinoma (RCC), endometrial cancer, squamous cell carcinoma of the head and neck (SCCHN), melanoma, non\u2013small-cell lung cancer (NSCLC), or urothelial cancer. The primary objective of phase Ib was to determine the maximum tolerated dose (MTD) for lenvatinib plus pembrolizumab (200 mg intravenously every 3 weeks). In the preplanned phase II cohort expansion, the primary objective was objective response rate at week 24 (ORR\n                      <jats:sub>week 24<\/jats:sub>\n                      ) at the recommended phase II dose.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Overall, 137 patients were enrolled during phase Ib (n = 13) and the initial phase II expansion (n = 124). Two dose-limiting toxicities (DLTs; grade 3 arthralgia and grade 3 fatigue) were reported in the initial dose level (lenvatinib 24 mg\/d plus pembrolizumab). No DLTs were observed in the subsequent dose\u2013de-escalation cohort, establishing the MTD and recommended phase II dose at lenvatinib 20 mg\/d plus pembrolizumab. ORR\n                      <jats:sub>week24<\/jats:sub>\n                      was as follows: RCC, 63% (19\/30; 95% CI, 43.9% to 80.1%); endometrial cancer, 52% (12\/23; 95% CI, 30.6% to 73.2%); melanoma, 48% (10\/21; 95% CI, 25.7% to 70.2%); SCCHN, 36% (8\/22; 95% CI, 17.2% to 59.3%); NSCLC, 33% (7\/21; 95% CI, 14.6% to 57.0%); and urothelial cancer 25% (5\/20; 95% CI, 8.7% to 49.1%). The most common treatment-related adverse events were fatigue (58%), diarrhea (52%), hypertension (47%), and hypothyroidism (42%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Lenvatinib plus pembrolizumab demonstrated a manageable safety profile and promising antitumor activity in patients with selected solid tumor types.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.19.01598","type":"journal-article","created":{"date-parts":[[2020,1,21]],"date-time":"2020-01-21T15:59:24Z","timestamp":1579622364000},"page":"1154-1163","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":374,"title":["Phase IB\/II Trial of Lenvatinib Plus Pembrolizumab in Patients With Advanced Renal Cell Carcinoma, Endometrial Cancer, and Other Selected Advanced Solid 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