Evidence map›Paper›PMID 35152908›Full record

ArticleTrials2022

Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced uveal melanoma (CHOPIN): study protocol for a phase Ib/randomized phase II trial.

T M L Tong, M K van der Kooij, F M Speetjens, A R van Erkel, R W van der Meer, J Lutjeboer, E L van Persijn van Meerten, C H Martini, R W M Zoethout, F G J Tijl and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04283890 (Phase1b/2 Study Combining Hepatic Percutaneous Perfusion With Ipilimumab Plus Nivolumab in Advanced Uveal Melanoma), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% 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.

NCT04283890 phase1 / phase2active not recruitingnot on this map

Phase1b/2 Study Combining Hepatic Percutaneous Perfusion With Ipilimumab Plus Nivolumab in Advanced Uveal Melanoma

TypeinterventionalSponsorLeiden University Medical CenterRan2019 to 2029Enrolled83ConditionsUveal Melanoma, MetastaticArmsIpilimumab and nivolumab, Melphalan chemosaturation via percutaneous hepatic perfusion
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. The Current State of Systemic Therapy of Metastatic Uveal Melanoma.American journal of clinical dermatology · 2024
    Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. 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

13 authors at 1 institution in 1 country.

T M L TongDepartment of Medical Oncology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands. T.M.L.Tong@lumc.nl.ORCID http://orcid.org/0000-0002-7381-6858
M K van der KooijDepartment of Medical Oncology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands.
F M SpeetjensDepartment of Medical Oncology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands.
A R van ErkelDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands.
R W van der MeerDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands.
J LutjeboerDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands.
E L van Persijn van MeertenDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands.
C H MartiniDepartment of Anesthesiology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands.
R W M ZoethoutDepartment of Anesthesiology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands.
F G J TijlDepartment of Extra Corporal Circulation, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands.
C U BlankDepartment of Medical Oncology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands.
M C BurgmansDepartment of Radiology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands.
E KapiteijnDepartment of Medical Oncology, Leiden University Medical Center, PO Box 9600, 2300, RC, Leiden, The Netherlands.
Leiden University Medical Center · NL

Funding

Bristol-Myers Squibb Not applicableDelcath Systems Inc. Not applicable
6 · The paper itself

Abstract

backgroundWhile immune checkpoint inhibition (ICI) has revolutionized the treatment of metastatic cutaneous melanoma, no standard treatments are available for patients with metastatic uveal melanoma (UM). Several locoregional therapies are effective in the treatment of liver metastases, such as percutaneous hepatic perfusion with melphalan (M-PHP). The available literature suggests that treatment with ICI following locoregional treatment of liver UM metastases can result in clinical response. We hypothesize that combining M-PHP with ICI will lead to enhanced antigen presentation and increased immunomodulatory effect, improving control of both hepatic and extrahepatic disease.

methodsOpen-label, single-center, phase Ib/randomized phase II trial, evaluating the safety and efficacy of the combination of M-PHP with ipilimumab (anti-CTLA-4 antibody) and nivolumab (anti-PD-1 antibody) in patients with unresectable hepatic metastases of UM in first-line treatment, with or without the limited extrahepatic disease. The primary objective is to determine the safety, toxicity, and efficacy of the combination regimen, defined by maximum tolerated dose (MTD) and progression-free survival (PFS) at 1 year. Secondary objectives include overall survival (OS) and overall response rate (ORR). A maximum of 88 patients will be treated in phase I and phase II combined. Baseline characteristics will be described with descriptive statistics (t-test, chi-square test). To study the association between risk factors and toxicity, a logistic regression model will be applied. PFS and OS will be summarized using Kaplan-Meier curves. DISCUSSION: This is the first trial to evaluate this treatment combination by establishing the maximum tolerated dose and evaluating the efficacy of the combination treatment. M-PHP has shown to be a safe and effective treatment for UM patients with liver metastases and became the standard treatment option in our center. The combination of ICI with M-PHP is investigated in the currently described trial which might lead to a better treatment response both in and outside the liver.

trial registrationThis trial was registered in the US National Library of Medicine with identifier NCT04283890 . Registered as per February 2020 - Retrospectively registered. EudraCT registration number: 2018-004248-49. Local MREC registration number: NL60508.058.19.

Indexed as

Chemotherapy, Cancer, Regional PerfusionMelanomaUveal NeoplasmsClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicHumansIpilimumabLiverNivolumabRandomized Controlled Trials as TopicUveal MelanomaIpilimumabNivolumabAdvanced uveal melanomaImmunotherapyLiver metastasesPercutaneous hepatic perfusion

Identifiers

PMID35152908
PMCPMC8842930
OpenAlexW4226128950

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.