Evidence map›Paper›PMID 27298410›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2016

Talimogene Laherparepvec in Combination With Ipilimumab in Previously Untreated, Unresectable Stage IIIB-IV Melanoma.

Igor Puzanov, Mohammed M Milhem, David Minor, Omid Hamid, Ai Li, Lisa Chen, Michael Chastain, Kevin S Gorski, Abraham Anderson, Jeffrey Chou and 2 more

2 registry-linked trialsAbstract readClinical Trial, Phase IVMulticenter Study
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, 2016. 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 345 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
345citing papers in PubMed, 6 pooled it
–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.

NCT01740297 phase1 / phase2completednot on this map

Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Unresected, Stage IIIB-IV Melanoma

TypeinterventionalSponsorAmgenRan2013 to 2021Enrolled217ConditionsMelanomaArmsTalimogene laherparepvec, Ipilimumab
NCT03792724 phase1 / phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Phase I-II Study of Intratumoral Urelumab Combined With Nivolumab in Patients With Solid Tumors

TypeinterventionalSponsorClinica Universidad de Navarra, Universidad de NavarraRan2019 to 2023Enrolled32ConditionsNeoplasmsArmsUrelumab + Nivolumab
3 · Its place in the literature

Who cites it

345 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
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  6. Clinical Application of Oncolytic Viruses: A Systematic Review.International journal of molecular sciences · 2020
    Pooled it
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  13. Tuning epigenetics to enhance cancer virotherapy.Acta pharmaceutica Sinica. B · 2026
    Review
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285 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

12 authors.

Igor PuzanovIgor Puzanov, Vanderbilt University, Nashville, TN; Mohammed M. Milhem, University of Iowa, Iowa City, IA; David Minor, California Pacific Melanoma Center, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles; and Ai Li, Lisa Chen, Michael Chastain, Kevin S. Gorski, Abraham Anderson, and Jeffrey Chou, Amgen, Thousand Oaks, CA; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; and Robert H.I. Andtbacka, University of Utah, Salt Lake City, UT. igor.puzanov@vanderbilt.edu.
Mohammed M MilhemIgor Puzanov, Vanderbilt University, Nashville, TN; Mohammed M. Milhem, University of Iowa, Iowa City, IA; David Minor, California Pacific Melanoma Center, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles; and Ai Li, Lisa Chen, Michael Chastain, Kevin S. Gorski, Abraham Anderson, and Jeffrey Chou, Amgen, Thousand Oaks, CA; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; and Robert H.I. Andtbacka, University of Utah, Salt Lake City, UT.
David MinorIgor Puzanov, Vanderbilt University, Nashville, TN; Mohammed M. Milhem, University of Iowa, Iowa City, IA; David Minor, California Pacific Melanoma Center, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles; and Ai Li, Lisa Chen, Michael Chastain, Kevin S. Gorski, Abraham Anderson, and Jeffrey Chou, Amgen, Thousand Oaks, CA; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; and Robert H.I. Andtbacka, University of Utah, Salt Lake City, UT.
Omid HamidIgor Puzanov, Vanderbilt University, Nashville, TN; Mohammed M. Milhem, University of Iowa, Iowa City, IA; David Minor, California Pacific Melanoma Center, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles; and Ai Li, Lisa Chen, Michael Chastain, Kevin S. Gorski, Abraham Anderson, and Jeffrey Chou, Amgen, Thousand Oaks, CA; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; and Robert H.I. Andtbacka, University of Utah, Salt Lake City, UT.
Ai LiIgor Puzanov, Vanderbilt University, Nashville, TN; Mohammed M. Milhem, University of Iowa, Iowa City, IA; David Minor, California Pacific Melanoma Center, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles; and Ai Li, Lisa Chen, Michael Chastain, Kevin S. Gorski, Abraham Anderson, and Jeffrey Chou, Amgen, Thousand Oaks, CA; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; and Robert H.I. Andtbacka, University of Utah, Salt Lake City, UT.
Lisa ChenIgor Puzanov, Vanderbilt University, Nashville, TN; Mohammed M. Milhem, University of Iowa, Iowa City, IA; David Minor, California Pacific Melanoma Center, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles; and Ai Li, Lisa Chen, Michael Chastain, Kevin S. Gorski, Abraham Anderson, and Jeffrey Chou, Amgen, Thousand Oaks, CA; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; and Robert H.I. Andtbacka, University of Utah, Salt Lake City, UT.
Michael ChastainIgor Puzanov, Vanderbilt University, Nashville, TN; Mohammed M. Milhem, University of Iowa, Iowa City, IA; David Minor, California Pacific Melanoma Center, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles; and Ai Li, Lisa Chen, Michael Chastain, Kevin S. Gorski, Abraham Anderson, and Jeffrey Chou, Amgen, Thousand Oaks, CA; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; and Robert H.I. Andtbacka, University of Utah, Salt Lake City, UT.
Kevin S GorskiIgor Puzanov, Vanderbilt University, Nashville, TN; Mohammed M. Milhem, University of Iowa, Iowa City, IA; David Minor, California Pacific Melanoma Center, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles; and Ai Li, Lisa Chen, Michael Chastain, Kevin S. Gorski, Abraham Anderson, and Jeffrey Chou, Amgen, Thousand Oaks, CA; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; and Robert H.I. Andtbacka, University of Utah, Salt Lake City, UT.
Abraham AndersonIgor Puzanov, Vanderbilt University, Nashville, TN; Mohammed M. Milhem, University of Iowa, Iowa City, IA; David Minor, California Pacific Melanoma Center, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles; and Ai Li, Lisa Chen, Michael Chastain, Kevin S. Gorski, Abraham Anderson, and Jeffrey Chou, Amgen, Thousand Oaks, CA; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; and Robert H.I. Andtbacka, University of Utah, Salt Lake City, UT.
Jeffrey ChouIgor Puzanov, Vanderbilt University, Nashville, TN; Mohammed M. Milhem, University of Iowa, Iowa City, IA; David Minor, California Pacific Melanoma Center, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles; and Ai Li, Lisa Chen, Michael Chastain, Kevin S. Gorski, Abraham Anderson, and Jeffrey Chou, Amgen, Thousand Oaks, CA; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; and Robert H.I. Andtbacka, University of Utah, Salt Lake City, UT.
Howard L KaufmanIgor Puzanov, Vanderbilt University, Nashville, TN; Mohammed M. Milhem, University of Iowa, Iowa City, IA; David Minor, California Pacific Melanoma Center, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles; and Ai Li, Lisa Chen, Michael Chastain, Kevin S. Gorski, Abraham Anderson, and Jeffrey Chou, Amgen, Thousand Oaks, CA; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; and Robert H.I. Andtbacka, University of Utah, Salt Lake City, UT.
Robert H I AndtbackaIgor Puzanov, Vanderbilt University, Nashville, TN; Mohammed M. Milhem, University of Iowa, Iowa City, IA; David Minor, California Pacific Melanoma Center, San Francisco; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles; and Ai Li, Lisa Chen, Michael Chastain, Kevin S. Gorski, Abraham Anderson, and Jeffrey Chou, Amgen, Thousand Oaks, CA; Howard L. Kaufman, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; and Robert H.I. Andtbacka, University of Utah, Salt Lake City, UT.

Funding

Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Christopher K Laubenthal · 2000 to 2026
$70.0M
6 · The paper itself

Abstract

purposeCombining immunotherapeutic agents with different mechanisms of action may enhance efficacy. We describe the safety and efficacy of talimogene laherparepvec (T-VEC; an oncolytic virus) in combination with ipilimumab (a cytotoxic T-lymphocyte-associated antigen 4 checkpoint inhibitor) in patients with advanced melanoma.

methodsIn this open-label, multicenter, phase Ib trial of T-VEC in combination with ipilimumab, T-VEC was administered intratumorally in week 1 (10(6) plaque-forming units/mL), then in week 4 and every 2 weeks thereafter (10(8) plaque-forming units/mL). Ipilimumab (3 mg/kg) was administered intravenously every 3 weeks for four infusions, beginning in week 6. The primary end point was incidence of dose-limiting toxicities. Secondary end points were objective response rate by immune-related response criteria and safety.

resultsMedian duration of treatment with T-VEC was 13.3 weeks (range, 2.0 to 95.4 weeks). Median follow-up time for survival analysis was 20.0 months (1.0 to 25.4 months). Nineteen patients were included in the safety analysis. No dose-limiting toxicities occurred, and no new safety signals were detected. Grade 3/4 treatment-related adverse events (AEs) were seen in 26.3% of patients; 15.8% had AEs attributed to T-VEC, and 21.1% had AEs attributed to ipilimumab. The objective response rate was 50%, and 44% of patients had a durable response lasting ≥ 6 months. Eighteen-month progression-free survival was 50%; 18-month overall survival was 67%.

conclusionT-VEC with ipilimumab had a tolerable safety profile, and the combination appeared to have greater efficacy than either T-VEC or ipilimumab monotherapy.

Indexed as

Oncolytic VirusesAdultAgedAged, 80 and overAntibodies, MonoclonalFemaleHumansIpilimumabMaleMelanomaMiddle AgedOncolytic VirotherapySkin NeoplasmsT-Lymphocyte SubsetsTumor BurdenAntibodies, MonoclonalIpilimumab

Identifiers

PMID27298410
PMCPMC7189507

What OpenQuestion holds

Textmetadata
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.