Evidence map›Paper›PMID 31961766›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Phase IB/II Trial of Lenvatinib Plus Pembrolizumab in Patients With Advanced Renal Cell Carcinoma, Endometrial Cancer, and Other Selected Advanced Solid Tumors.

Matthew H Taylor, Chung-Han Lee, Vicky Makker, Drew Rasco, Corina E Dutcus, Jane Wu, Daniel E Stepan, Robert C Shumaker, Robert J Motzer

Erratum issued Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04445532 (Acquisition of Blood and Tumor Tissue Samples From Patients With Hepatobiliary Tumors), which is not on this map. Cited by 270 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
270citing papers in PubMed, 8 pooled it
27.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT04445532 unknown statusnot on this map

Acquisition of Blood and Tumor Tissue Samples From Patients With Hepatobiliary Tumors

TypeobservationalSponsorPeking Union Medical College HospitalRan2020 to 2025Enrolled450ConditionsHepatocellular Carcinoma, Cholangiocarcinoma, Gallbladder Cancer, Biliary Tract CancerArmsGene expression analysis, Genomic analysis, Protein expression analysis, Proteomic profiling, Polymerase chain reaction
3 · Its place in the literature

Who cites it

270 citing papers in PubMed, 8 syntheses or guidelines pooled it, 450 citations in OpenAlex.

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210 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Matthew H TaylorKnight Cancer Institute, Oregon Health and Science University, Portland, OR.
Chung-Han LeeMemorial Sloan Kettering Cancer Center, New York, NY.
Vicky MakkerMemorial Sloan Kettering Cancer Center, New York, NY.
Drew RascoSTART, San Antonio, TX.
Corina E DutcusEisai Inc, Woodcliff Lake, NJ.
Jane WuEisai Inc, Woodcliff Lake, NJ.
Daniel E StepanFormerly of Eisai Inc, Woodcliff Lake, NJ.
Robert C ShumakerEisai Inc, Woodcliff Lake, NJ.
Robert J MotzerMemorial Sloan Kettering Cancer Center, New York, NY.
Eisai (United States) · USMemorial Sloan Kettering Cancer Center · USOregon Health & Science University · USSouth Texas Accelerated Research Therapeutics · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeModulation of vascular endothelial growth factor-mediated 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.

methodsEligible patients had metastatic renal cell carcinoma (RCC), endometrial cancer, squamous cell carcinoma of the head and neck (SCCHN), melanoma, non-small-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

resultsOverall, 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-de-escalation cohort, establishing the MTD and recommended phase II dose at lenvatinib 20 mg/d plus pembrolizumab. ORR

conclusionLenvatinib plus pembrolizumab demonstrated a manageable safety profile and promising antitumor activity in patients with selected solid tumor types.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Renal CellCohort StudiesEndometrial NeoplasmsFemaleHumansKidney NeoplasmsMaleMaximum Tolerated DoseMelanomaMiddle AgedNeoplasmsAntibodies, Monoclonal, HumanizedlenvatinibpembrolizumabPhenylurea CompoundsQuinolines

Identifiers

PMID31961766
PMCPMC7145588
OpenAlexW3001232216

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.