Evidence map›Paper›PMID 33125309›Full record

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

Nivolumab and Ipilimumab in Metastatic Uveal Melanoma: Results From a Single-Arm Phase II Study.

Meredith S Pelster, Stephen K Gruschkus, Roland Bassett, Dan S Gombos, Michael Shephard, Liberty Posada, Maura S Glover, Rinata Simien, Adi Diab, Patrick Hwu and 2 more

Open access · bronzeAbstract readClinical Trial, Phase II
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, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 196 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
196citing papers in PubMed, 9 pooled it
27.3field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

196 citing papers in PubMed, 9 syntheses or guidelines pooled it, 291 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 1 institution in 1 country.

Meredith S PelsterDivision of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0003-2790-4475
Stephen K GruschkusDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
Roland BassettDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
Dan S GombosDepartment of Head and Neck Surgery, Section of Ophthalmology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Michael ShephardDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Liberty PosadaDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Maura S GloverDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Rinata SimienDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Adi DiabDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Patrick HwuDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Brett W CarterDivision of Diagnostic Imaging, The University of Texas MD Anderson Cancer Center, Houston, TX.
Sapna P PatelDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0003-1339-1517
The University of Texas MD Anderson Cancer Center · US

Funding

The University of Texas MD Anderson Cancer Center SPORE in MelanomaP50CA221703 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DAVIES, MICHAEL · 2019 to 2023
$10.3M
NCI NIH HHS P50 CA221703
6 · The paper itself

Abstract

purposeMetastatic uveal melanoma has poor overall survival (OS) and no approved systemic therapy options. Studies of single-agent immunotherapy regimens have shown minimal benefit. There is the potential for improved responses with the use of combination immunotherapy. PATIENTS AND

methodsWe conducted a phase II study of nivolumab with ipilimumab in patients with metastatic uveal melanoma. Any number of prior treatments was permitted. Patients received nivolumab 1 mg/kg and ipilimumab 3 mg/kg for four cycles, followed by nivolumab maintenance therapy for up to 2 years. The primary outcome of the study was overall response rate (ORR) as determined by RECIST 1.1 criteria. Progression-free survival (PFS), OS, and adverse events were also assessed.

resultsThirty-five patients were enrolled, and 33 patients were evaluable for efficacy. The ORR was 18%, including one confirmed complete response and five confirmed partial responses. The median PFS was 5.5 months (95% CI, 3.4 to 9.5 months), and the median OS was 19.1 months (95% CI, 9.6 months to NR). Forty percent of patients experienced a grade 3-4 treatment-related adverse event.

conclusionThe combination regimen of nivolumab plus ipilimumab demonstrates activity in metastatic uveal melanoma, with deep and sustained confirmed responses.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansIpilimumabMaleMelanomaMiddle AgedNivolumabUveal MelanomaUveal NeoplasmsIpilimumabNivolumab

Identifiers

PMID33125309
PMCPMC8257877
OpenAlexW3096267580

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.