Evidence map›Paper›PMID 36651961›Full record

ArticleJournal of cancer research and clinical oncology2023

Phase 1b study of intravenous coxsackievirus A21 (V937) and ipilimumab for patients with metastatic uveal melanoma.

Jose Lutzky, Ryan J Sullivan, Justine V Cohen, Yixin Ren, Anlong Li, Rizwan Haq

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

Article in Journal of cancer research and 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 trial NCT03408587 (An Open-Label Phase 1b Clinical Study of Intravenous CAVATAK®), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
5.9field-weighted citation impact, top 3% 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.

NCT03408587 phase1completednot on this map

An Open-Label Phase 1b Clinical Study of Intravenous CAVATAK® (Coxsackievirus A21, CVA21), in Combination With Ipilimumab in Subjects With Uveal Melanoma Metastatic to Liver (VLA-024 CLEVER)

TypeinterventionalSponsorViralyticsRan2018 to 2019Enrolled11ConditionsUveal Melanoma, Liver MetastasesArmsCVA21, Ipilimumab
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
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  12. Virus nanotechnology for intratumoural immunotherapy.Nature reviews bioengineering · 2024
    Article
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  15. Uveal melanoma: Recent advances in immunotherapy.World journal of clinical oncology · 2024
    Review
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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

6 authors at 4 institutions in 1 country.

Jose LutzkySylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, 1475 NW 12th Ave, Miami, FL, 33136, USA. jose.lutzky@med.miami.edu.ORCID http://orcid.org/0000-0002-9503-2130
Ryan J SullivanMassachusetts General Hospital, Boston, MA, USA.
Justine V CohenMassachusetts General Hospital, Boston, MA, USA.
Yixin RenMerck & Co., Inc., Rahway, NJ, USA.
Anlong LiMerck & Co., Inc., Rahway, NJ, USA.
Rizwan HaqDepartment of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Massachusetts General Hospital · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USHarvard University · USUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeNo standard of care therapy exists for patients with metastatic uveal melanoma who are not HLA-A2:01 positive. The phase 1b, open-label CLEVER study (NCT03408587) evaluated V937 in combination with ipilimumab in patients with uveal melanoma.

methodsAdults with advanced uveal melanoma and liver metastases received up to 8 cycles of intravenous V937 (1 × 10

resultsEleven patients were enrolled (median age, 65.0 years) and received a median of 6 injections of V937 and 3.5 infusions of ipilimumab. The best overall response was stable disease in 3 patients and progressive disease in 8 patients. All patients exhibited progression per irRECIST, with a 9% irPFS rate at week 26. Ten patients had treatment-related AEs, the most frequent of which were diarrhea (55%), fatigue (45%), and myalgia (36%). Two grade 3 AEs (diarrhea, n = 2) were considered related to ipilimumab; neither was related to V937.

conclusionAlthough the combination of V937 with ipilimumab had a manageable safety profile, meaningful clinical benefit was not observed in patients with uveal melanoma and liver metastases.

trial registrationClinicalTrials.gov, NCT03408587 (January 24, 2018).

Indexed as

MelanomaUveal NeoplasmsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsDiarrheaHumansIpilimumabUveal MelanomaIpilimumabImmunotherapyMelanomaOncolytic virotherapyOncolytic viruses

Identifiers

PMID36651961
PMCPMC10356892
OpenAlexW4317207980

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.