Evidence map›Paper›PMID 31353364›Full record

Trial reportBritish journal of cancer2019

Patterns of response with talimogene laherparepvec in combination with ipilimumab or ipilimumab alone in metastatic unresectable melanoma.

Jason Chesney, Igor Puzanov, Frances Collichio, Mohammed M Milhem, Axel Hauschild, Lisa Chen, Anjali Sharma, Claus Garbe, Parminder Singh, Janice M Mehnert

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01740297 (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), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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.

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
3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
  7. Oncolytic intralesional therapy for metastatic melanoma.Clinical & experimental metastasis · 2024
    Review
  8. Clinical applications of gene therapy for rare diseases: A review.International journal of experimental pathology · 2023
    Review
  9. Review
  10. Article
  11. Review
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Oncolytic viruses for cancer immunotherapy.Journal of hematology & oncology · 2020
    Review
  18. Review
  19. Review
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

10 authors.

Jason ChesneyJames Graham Brown Cancer Center, University of Louisville, Louisville, KY, USA. jason.chesney@louisville.edu.
Igor PuzanovRoswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Frances CollichioThe University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Mohammed M MilhemUniversity of Iowa Hospitals and Clinics, Iowa City, IA, USA.
Axel HauschildUniversity of Kiel, Kiel, Germany.
Lisa ChenAmgen Inc., Thousand Oaks, CA, USA.
Anjali SharmaAmgen Inc., Thousand Oaks, CA, USA.
Claus GarbeUniversity Hospital Tübingen, Tübingen, Germany.
Parminder SinghMayo Clinic, Phoenix, AZ, USA.
Janice M MehnertRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.

Funding

Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Douglas Robert Spitz · 2000 to 2026
$70.0M
6 · The paper itself

Abstract

Talimogene laherparepvec (T-VEC) has demonstrated efficacy for unresectable melanoma. We explored response patterns from a phase 2 study evaluating patients with unresectable stage IIIB-IVM1c malignant melanoma who received T-VEC plus ipilimumab or ipilimumab alone. Patients with objective response per modified irRC were evaluated for pseudo-progression (single ≥25% increase in tumour burden before response). Patients without pseudo-progression were classified by whether they responded within or after 6 months of treatment start; those with pseudo-progression were classified by whether pseudo-progression was due to increase in existing lesions or development of new lesions. Overall, 39% (n = 38/98) in the combination arm and 18% (n = 18/100) in the ipilimumab arm had an objective response. Eight responders (combination, n = 7 [18.4%]; ipilimumab, n = 1 [5.6%]) had pseudo-progression; most occurred by week 12 and were caused by an increase in existing lesions. These data reinforce use of T-VEC through initial progression when combined with checkpoint inhibitors.Trial Registration NCT01740297 (ClinicalTrials.gov; date of registration, December 4, 2012); 2012-000307-32 (ClinicalTrialsRegister.eu; date of registration, May 13, 2014).

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiological ProductsFemaleHerpesvirus 1, HumanHumansInjections, IntralesionalIpilimumabMaleMelanomaMiddle AgedSkin NeoplasmsTreatment OutcomeBiological ProductsIpilimumabtalimogene laherparepvec

Identifiers

PMID31353364
PMCPMC6738060

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.