Evidence map›Paper›PMID 33417511›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Nivolumab Plus Ipilimumab for Treatment-Naïve Metastatic Uveal Melanoma: An Open-Label, Multicenter, Phase II Trial by the Spanish Multidisciplinary Melanoma Group (GEM-1402).

José María Piulats, Enrique Espinosa, Luis de la Cruz Merino, Mar Varela, Lorenzo Alonso Carrión, Salvador Martín-Algarra, Rafael López Castro, Teresa Curiel, Delvys Rodríguez-Abreu, Miriam Redrado and 4 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05047276 (Phase I/II Study of AloCelyvir in Patients With Metastatic Uveal Melanoma), which is not on this map. Cited by 151 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
151citing papers in PubMed, 11 pooled it
31.8field-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.

NCT05047276 phase1 / phase2unknown statusnot on this map

Phase I/II Study of AloCelyvir in Patients With Metastatic Uveal Melanoma

TypeinterventionalSponsorJosé María Piulats RodríguezRan2021 to 2024Enrolled16ConditionsUveal Melanoma, MetastaticArmsAloCelyvir
3 · Its place in the literature

Who cites it

151 citing papers in PubMed, 11 syntheses or guidelines pooled it, 231 citations in OpenAlex.

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91 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 11 institutions in 1 country.

José María PiulatsMedical Oncology Department, Catalan Institute of Cancer (ICO), IDIBELL-OncoBell, L'Hospitalet de Llobregat, Barcelona, Spain.ORCID 0000-0002-3606-1724
Enrique EspinosaCentro de Investigación Biomédica en Red de Cáncer (CIBERONC), Madrid, Spain.
Luis de la Cruz MerinoMedical Oncology, Hospital Universitario Virgen Macarena, Department of Medicine, Universidad de Sevilla, Sevilla, Spain.ORCID 0000-0002-5333-0535
Mar VarelaPathology Department, Hospital Universitari de Bellvitge (HUB), L'Hospitalet de Llobregat, Barcelona, Spain.ORCID 0000-0002-2129-6336
Lorenzo Alonso CarriónMedical Oncology, Hospital Universitario Virgen de la Victoria, Málaga, Spain.
Salvador Martín-AlgarraMedical Oncology, Clínica Universidad de Navarra, Pamplona, Spain.
Rafael López CastroMedical Oncology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.ORCID 0000-0003-4770-4710
Teresa CurielMedical Oncology, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.ORCID 0000-0003-2791-9554
Delvys Rodríguez-AbreuMedical Oncology, Complejo Hospitalario Universitario Insular Materno Infantil, Las Palmas de Gran Canaria, Spain.ORCID 0000-0003-0506-1366
Miriam RedradoCentro de Investigación Biomédica en Red de Cáncer (CIBERONC), Madrid, Spain.
Montserrat GomàPathology Department, Hospital Universitari de Bellvitge (HUB), L'Hospitalet de Llobregat, Barcelona, Spain.
Antonio José RullánMedical Oncology Department, Catalan Institute of Cancer (ICO), IDIBELL-OncoBell, L'Hospitalet de Llobregat, Barcelona, Spain.ORCID 0000-0002-7365-9629
Alfonso Calvo GonzálezCentro de Investigación Biomédica en Red de Cáncer (CIBERONC), Madrid, Spain.
Alfonso Berrocal-JaimeMedical Oncology, Complejo Hospitalario General Universitario de Valencia, Valencia, Spain.
Bellvitge University Hospital · ESCentro de Investigación Biomédica en Red de Cáncer · ESClinica Universidad de Navarra · ESComplejo Hospitalario Universitario de Santiago · ESHospital Clínico Universitario de Valladolid · ESHospital Clínico Universitario Virgen de la Victoria · ESHospital General Universitario De Valencia · ESHospital Universitario Insular de Gran Canaria · ESHospital Universitario La Paz · ESHospital Universitario Virgen Macarena · ESInstitut d'Investigació Biomédica de Bellvitge · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study aimed to assess the efficacy of the combination of nivolumab (nivo) plus ipilimumab (ipi) as a first-line therapy with respect to the 12-month overall survival (OS) in patients with metastatic uveal melanoma (MUM) who are not eligible for liver resection.

methodsThis was a single-arm, phase II trial led by the Spanish Multidisciplinary Melanoma Group (GEM) on nivo plus ipi for systemic treatment-naïve patients of age > 18 years, with histologically confirmed MUM, Eastern Cooperative Oncology Group-PS 0/1, and confirmed progressive metastatic disease (M1). Nivo (1 mg/kg once every 3 weeks) and ipi (3 mg/kg once every 3 weeks) were administered during four inductions, followed by nivo (3 mg/kg once every 2 weeks) until progressive disease, toxicity, or withdrawal. The primary end point was 12-month OS. OS, progression-free survival (PFS), and overall response rate were evaluated every 6 weeks using RECIST (v1.1). Safety was also evaluated. Logistic regression and Cox proportional hazard models comprising relevant clinical factors were used to evaluate the potential association with response to treatment and survival. Cytokines were quantified in serum samples for their putative role in immune modulation/angiogenesis and/or earlier evidence of involvement in immunotherapy.

resultsA total of 52 patients with a median age of 59 years (range, 26-84 years) were enrolled. Overall, 78.8%, 56%, and 32% of patients had liver M1, extra-liver M1, and elevated lactate dehydrogenase. Stable disease was the most common outcome (51.9%). The primary end point was 12-month OS, which was 51.9% (95% CI, 38.3 to 65.5). The median OS and PFS were 12.7 months and 3.0 months, respectively. PFS was influenced by higher LDH values.

conclusionsNivo plus ipi in the first-line setting for MUM showed a modest improvement in OS over historical benchmarks of chemotherapy, with a manageable toxicity profile.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansIpilimumabMaleMelanomaMiddle AgedNivolumabSurvival AnalysisUveal MelanomaUveal NeoplasmsIpilimumabNivolumab

Identifiers

PMID33417511
OpenAlexW3120989185

What OpenQuestion holds

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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.