Evidence map›Paper›PMID 42140948›Full record

Trial reportNature communications2026

A phase II peri-operative study of pembrolizumab plus lenvatinib for mucosal melanoma.

Lili Mao, Yumei Lai, Hong Zheng, Ming Cui, Lifeng Li, Ziyi Liu, Hongyu Zhou, Linzi Sun, Caili Li, Xiaoting Wei and 16 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Nature 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 NCT04622566 (A Phase II Study of Neoadjuvant Lenvatinib and Pembrolizumab in Resectable Mucosal Melanoma), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT04622566 phase2not yet recruitingnot on this map

A Phase II Study of Neoadjuvant Lenvatinib and Pembrolizumab in Resectable Mucosal Melanoma

TypeinterventionalSponsorPeking University Cancer Hospital & InstituteRan2020 to 2023Enrolled26ConditionsMucosal Melanoma, Neoadjuvant TreatmentArmsLenvatinib, Pembrolizumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Lili Mao *Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Yumei Lai *Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Pathology, Peking University Cancer Hospital and Institute, Beijing, China.
Hong Zheng *Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gynaecology, Peking University Cancer Hospital and Institute, Beijing, China.
Ming Cui *Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Surgery IV, Peking University Cancer Hospital and Institute, Beijing, China.
Lifeng LiGeneplus-Beijing, Beijing, China.ORCID http://orcid.org/0000-0002-9813-5688
Ziyi LiuKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Hongyu ZhouKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Linzi SunKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Caili LiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Xiaoting WeiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Junjie GuKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
Xue BaiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Yan KongKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.ORCID http://orcid.org/0000-0002-2266-7872
Chuanliang CuiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Zhihong ChiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Xinan ShengKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital and Institute, Beijing, China.ORCID http://orcid.org/0000-0001-9359-0975
Bin LianKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Siming LiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Xieqiao YanKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
Bixia TangKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
Juan LiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
Li ZhouKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.ORCID http://orcid.org/0000-0002-9331-0600
Xuan WangKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Jun GuoKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China.
Jie DaiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China. jiedai@pku.edu.cn.
Lu SiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Sarcoma, Peking University Cancer Hospital and Institute, Beijing, China. silu15_silu@126.com.ORCID http://orcid.org/0000-0002-2123-9761

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Mucosal melanoma is an aggressive malignancy with limited neoadjuvant options. We conducted a single arm, phase II study of neoadjuvant pembrolizumab plus lenvatinib followed by surgery and adjuvant pembrolizumab in resectable mucosal melanoma (NCT04622566) along with exploratory biomarker analysis. Primary objective was pathological complete response (pCR) rate; secondary endpoints included relapse-free survival (RFS), overall survival (OS), clinical response, surgical outcomes, and safety. Among 21 surgical patients, the pCR rate was 9.5%, major pathologic response (MPR) rate was 19.0%, and the pathologic response rate was 38.1%. Median RFS was 14.8 months (1-year rate: 61.9%); median OS was not reached. No grade 4-5 treatment-related toxicities or additional perioperative complications occcurred. Spatial profiling revealed a more immune-inflamed baseline microenvironment in responders, with activated CD4⁺/CD8⁺ T cell signatures associated with favorable outcomes. Treatment induced vascular normalization and increased T cell infiltration in non-responders, partially narrowing the immune gap. Responders exhibited higher prevalence of persistent TCR clonotypes and tighter spatial proximity between activated CD4⁺ and CD8⁺ T cells. Although the pre-specified primary endpoint was not met, our findings identify activated CD4

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsMelanomaPhenylurea CompoundsQuinolinesAdultAgedFemaleHumansMaleMiddle AgedMucous MembraneNeoadjuvant TherapyPathologic Complete ResponseTreatment OutcomeTumor MicroenvironmentAntibodies, Monoclonal, HumanizedlenvatinibpembrolizumabPhenylurea CompoundsQuinolines

Identifiers

PMID42140948
PMCPMC13376369

What OpenQuestion holds

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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.