Evidence map›Paper›PMID 35998300›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Randomized, Double-Blind, Placebo-Controlled, Global Phase III Trial of Talimogene Laherparepvec Combined With Pembrolizumab for Advanced Melanoma.

Jason A Chesney, Antoni Ribas, Georgina V Long, John M Kirkwood, Reinhard Dummer, Igor Puzanov, Christoph Hoeller, Thomas F Gajewski, Ralf Gutzmer, Piotr Rutkowski and 19 more

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 226 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
226citing papers in PubMed, 4 pooled it
23.6field-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.

NCT02263508 phase3terminatednot on this map

A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)

TypeinterventionalSponsorAmgenRan2014 to 2021Enrolled713ConditionsMelanomaArmsTalimogene Laherparepvec, Pembrolizumab, Placebo
NCT06080984 phase1unknown statusnot on this map

The Application of Novel Oncolytic Virus in Late Stage Solid Tumors

TypeinterventionalSponsorWest China HospitalRan2023 to 2025Enrolled24ConditionsMalignant TumorArmsOncolytic Virus SDJ001, Oncolytic Virus YD06-1
3 · Its place in the literature

Who cites it

226 citing papers in PubMed, 4 syntheses or guidelines pooled it, 249 citations in OpenAlex.

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  15. Oncolytic adenovirus in treating malignant ascites: A phase II trial and longitudinal single-cell study.Molecular therapy : the journal of the American Society of Gene Therapy · 2024
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  16. Bempegaldesleukin Plus Nivolumab in Untreated Advanced Melanoma: The Open-Label, Phase III PIVOT IO 001 Trial Results.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
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166 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

29 authors at 20 institutions in 14 countries.

Jason A ChesneyUofL Health-Brown Cancer Center, University of Louisville, Louisville, KY.ORCID 0000-0003-0217-8278
Antoni RibasJonsson Comprehensive Cancer Center at the University of California Los Angeles, Los Angeles, CA.ORCID 0000-0003-3669-8458
Georgina V LongMelanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia.ORCID 0000-0001-8894-3545
John M KirkwoodUPMC Hillman Cancer Center, Pittsburgh, PA.ORCID 0000-0002-3570-4476
Reinhard DummerUniversity Hospital of Zurich, Zurich, Switzerland.ORCID 0000-0002-2279-6906
Igor PuzanovRoswell Park Comprehensive Cancer Center, Buffalo, NY.ORCID 0000-0002-9803-3497
Christoph HoellerDepartment of Dermatology, Medical University of Vienna, Vienna, Austria.
Thomas F GajewskiUniversity of Chicago Medical Center, Chicago, IL.
Ralf GutzmerMedizinische Hochschule Hannover, Hannover, Germany.ORCID 0000-0001-7921-2820
Piotr RutkowskiMaria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.ORCID 0000-0002-8920-5429
Lev DemidovN.N. Blokhin Russian Cancer Research Center, Moscow, Russia.
Petr ArenbergerUniversity Hospital Královské Vinohrady, Prague, Czech Republic.
Sang Joon ShinDivision of Oncology, Yonsei University College of Medicine, Seoul, Korea.
Pier Francesco FerrucciBiotherapy of Tumors Unit, Department of Experimental Oncology, European Institute of Oncology, IRCCS, Milan, Italy.ORCID 0000-0001-6255-5851
Andrew HaydonDepartment of Medical Oncology, Alfred Hospital, Melbourne, Australia.ORCID 0000-0002-4631-5855
John HyngstromHuntsman Cancer Institute, University of Utah Health, Salt Lake City, UT.ORCID 0000-0002-4833-3838
Johannes V van ThienenNetherlands Cancer Institute, Amsterdam, the Netherlands.
Sebastian HaferkampDepartment of Dermatology, University Hospital Regensburg, Regensburg, Germany.ORCID 0000-0002-3894-8345
Josep Malvehy GuileraDepartment of Dermatology, Barcelona University, Barcelona, IDIBAPS, CIBER de Enfermedades Raras ISCIII, Madrid, Spain.ORCID 0000-0002-6998-914X
Bernardo Leon RapoportThe Medical Oncology Centre of Rosebank, Johannesburg, South Africa.ORCID 0000-0001-7610-3653
Ari VanderWaldeDepartment of Hematology/Oncology, West Cancer Center & Research Institute, Memphis, TN.ORCID 0000-0002-6842-2563
Scott J DiedeMerck & Co, Inc, Kenilworth, NJ.ORCID 0000-0001-5422-549X
James R AndersonMerck & Co, Inc, Kenilworth, NJ.
Sheryl TreichelAmgen Inc, South San Francisco, CA.
Edward L ChanAmgen Inc, Thousand Oaks, CA.
Sumita BhattaAmgen Inc, Thousand Oaks, CA.
Jennifer GansertAmgen Inc, Thousand Oaks, CA.
Frank Stephen HodiDana-Farber Cancer Institute, Boston, MA.
Helen GogasNational and Kapodistrian University of Athens, Athens, Greece.ORCID 0000-0002-0451-2885
Amgen (United States) · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USDana-Farber Cancer Institute · USEuropean Institute of Oncology · ITInstituto de Salud Carlos III · ESMedical University of Vienna · ATMedizinische Hochschule Hannover · DENational and Kapodistrian University of Athens · GRRoswell Park Comprehensive Cancer Center · USRussian Cancer Research Center NN Blokhin · RUThe Alfred Hospital · AUThe Maria Sklodowska-Curie National Research Institute of Oncology · PLThe Medical Oncology Centre of Rosebank · ZAThe Netherlands Cancer Institute · NLThe University of Sydney · AUUniversity Hospital Kralovske Vinohrady · CZUniversity Hospital of Zurich · CHUniversity Hospital Regensburg · DEUniversity of California, Los Angeles · USUniversity of Louisville · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe combination of talimogene laherparepvec (T-VEC) and pembrolizumab previously demonstrated an acceptable safety profile and an encouraging complete response rate (CRR) in patients with advanced melanoma in a phase Ib study. We report the efficacy and safety from a phase III, randomized, double-blind, multicenter, international study of T-VEC plus pembrolizumab (T-VEC-pembrolizumab) versus placebo plus pembrolizumab (placebo-pembrolizumab) in patients with advanced melanoma.

methodsPatients with stage IIIB-IVM1c unresectable melanoma, naïve to antiprogrammed cell death protein-1, were randomly assigned 1:1 to T-VEC-pembrolizumab or placebo-pembrolizumab. T-VEC was administered at ≤ 4 × 10

resultsOverall, 692 patients were randomly assigned (346 T-VEC-pembrolizumab and 346 placebo-pembrolizumab). T-VEC-pembrolizumab did not significantly improve PFS (hazard ratio, 0.86; 95% CI, 0.71 to 1.04;

conclusionT-VEC-pembrolizumab did not significantly improve PFS or OS compared with placebo-pembrolizumab. Safety results of the T-VEC-pembrolizumab combination were consistent with the safety profiles of each agent alone.

Indexed as

Herpesvirus 1, HumanMelanomaOncolytic VirotherapyAntibodies, Monoclonal, HumanizedBiological ProductsDouble-Blind MethodHumansAntibodies, Monoclonal, HumanizedBiological Productspembrolizumabtalimogene laherparepvec

Identifiers

PMID35998300
PMCPMC9870217
OpenAlexW4292851027

What OpenQuestion holds

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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.