Evidence map›Paper›PMID 36229663›Full record

Trial reportNature medicine2022

Clinical and molecular response to tebentafusp in previously treated patients with metastatic uveal melanoma: a phase 2 trial.

Richard D Carvajal, Marcus O Butler, Alexander N Shoushtari, Jessica C Hassel, Alexandra Ikeguchi, Leonel Hernandez-Aya, Paul Nathan, Omid Hamid, Josep M Piulats, Matthew Rioth and 11 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Nature medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02570308 (A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Using the Intra-patient Escalation Dosing Regimen in Patients With Advanced Uveal Melanoma), which is not on this map. Cited by 107 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
107citing papers in PubMed, 6 pooled it
28.2field-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.

NCT02570308 phase1 / phase2completednot on this map

A Phase I/II Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Using the Intra-patient Escalation Dosing Regimen in Patients With Advanced Uveal Melanoma

TypeinterventionalSponsorImmunocore LtdRan2016 to 2022Enrolled146ConditionsUveal MelanomaArmsIMCgp100
3 · Its place in the literature

Who cites it

107 citing papers in PubMed, 6 syntheses or guidelines pooled it, 144 citations in OpenAlex.

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  20. Dermatologic Adverse Events Associated with T-Cell Engager Therapy.American journal of clinical dermatology · 2026
    Review

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

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

21 authors at 18 institutions in 5 countries.

Richard D CarvajalHerbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY, USA.ORCID http://orcid.org/0000-0002-3796-1118
Marcus O ButlerPrincess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.ORCID http://orcid.org/0000-0002-9840-7057
Alexander N ShoushtariMemorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID http://orcid.org/0000-0002-8065-4412
Jessica C HasselUniversity Hospital Heidelberg, Heidelberg, Germany.
Alexandra IkeguchiStephenson Cancer Center, University of Oklahoma, Oklahoma City, OK, USA.ORCID http://orcid.org/0000-0002-4448-9755
Leonel Hernandez-AyaWashington University School of Medicine, Saint Louis, MO, USA.
Paul NathanMount Vernon Cancer Centre - East and North Herts NHS Trust, Northwood, Middlesex, UK.
Omid HamidThe Angeles Clinic and Research Institute, a Cedars-Sinai Affiliate, Los Angeles, CA, USA.
Josep M PiulatsInstitut Català d'Oncologia l'Hospitalet (Hospital Duran i Reynals), Hospitalet de Llobregat, Barcelona, Spain.
Matthew RiothUC Cancer Center, University of Colorado, Aurora, CO, USA.
Douglas B JohnsonVanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA.ORCID http://orcid.org/0000-0002-6390-773X
Jason J LukeUPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA.
Enrique EspinosaHospital Universitario La Paz - CIBERONC, Madrid, Spain.
Serge LeyvrazCharité Comprehensive Cancer Center, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Laura CollinsImmunocore, Abingdon-on-Thames, UK.
Howard M GoodallImmunocore, Abingdon-on-Thames, UK.
Koustubh RanadeImmunocore, Rockville, MD, USA.
Chris HollandImmunocore, Rockville, MD, USA.
Shaad E AbdullahImmunocore, Rockville, MD, USA.ORCID http://orcid.org/0000-0003-0776-7477
Joseph J SaccoClatterbridge Cancer Center - NHS Foundation Trust, Wirral, UK.ORCID http://orcid.org/0000-0003-2591-9796
Takami SatoSidney Kimmel Cancer Center, Jefferson University, Philadelphia, PA, USA. takami.sato@jefferson.edu.ORCID http://orcid.org/0000-0003-2221-0415
Immunocore (United States) · USImmunocore (United Kingdom) · GBAngeles Clinic and Research Institute · USCharité - Universitätsmedizin Berlin · DEColumbia University Irving Medical Center · USHeidelberg University · DEHospital Universitario La Paz · ESInstitut Català d'Oncologia · ESMemorial Sloan Kettering Cancer Center · USMount Vernon Cancer Centre · GBOklahoma State University Oklahoma City · USSidney Kimmel Cancer Center · USUniversity of Colorado Cancer Center · USUniversity of Liverpool · GBUniversity of Toronto · CAUPMC Hillman Cancer Center · USVanderbilt University Medical Center · USWashington University in St. Louis · US

Funding

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

Abstract

In patients with previously treated metastatic uveal melanoma, the historical 1 year overall survival rate is 37% with a median overall survival of 7.8 months. We conducted a multicenter, single-arm, open-label phase 2 study of tebentafusp, a soluble T cell receptor bispecific (gp100×CD3), in 127 patients with treatment-refractory metastatic uveal melanoma (NCT02570308). The primary endpoint was the estimation of objective response rate based on RECIST (Response Evaluation Criteria in Solid Tumours) v1.1. Secondary objectives included safety, overall survival, progression-free survival and disease control rate. All patients had at least one treatment-related adverse event, with rash (87%), pyrexia (80%) and pruritus (67%) being the most common. Toxicity was mostly mild to moderate in severity but was greatly reduced in incidence and intensity after the initial three doses. Despite a low overall response rate of 5% (95% CI: 2-10%), the 1 year overall survival rate was 62% (95% CI: 53-70%) with a median overall survival of 16.8 months (95% CI: 12.9-21.3), suggesting benefit beyond traditional radiographic-based response criteria. In an exploratory analysis, early on-treatment reduction in circulating tumour DNA was strongly associated with overall survival, even in patients with radiographic progression. Our findings indicate that tebentafusp has promising clinical activity with an acceptable safety profile in patients with previously treated metastatic uveal melanoma, and data suggesting ctDNA as an early indicator of clinical benefit from tebentafusp need confirmation in a randomized trial.

Indexed as

MelanomaUveal NeoplasmsHumansProgression-Free SurvivalRecombinant Fusion ProteinsUveal MelanomaRecombinant Fusion Proteinstebentafusp

Identifiers

PMID36229663
PMCPMC9671803
OpenAlexW4305015938

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.