Evidence map›Paper›PMID 37931206›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Standard Versus Modified Ipilimumab, in Combination With Nivolumab, in Advanced Renal Cell Carcinoma: A Randomized Phase II Trial (PRISM).

Naveen S Vasudev, Gemma Ainsworth, Sarah Brown, Lisa Pickering, Tom Waddell, Kate Fife, Richard Griffiths, Anand Sharma, Eszter Katona, Helen Howard and 17 more

Open access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.4field-weighted citation impact, top 7% 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

9 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
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  4. Emerging new immune checkpoint inhibitors in solid tumor immunotherapy.Naunyn-Schmiedeberg's archives of pharmacology · 2025
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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

27 authors at 16 institutions in 1 country.

Naveen S VasudevLeeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.ORCID 0000-0001-8470-7481
Gemma AinsworthClinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.ORCID 0000-0002-9952-8440
Sarah BrownClinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.ORCID 0000-0002-7975-7537
Lisa PickeringRoyal Marsden Hospital, London, United Kingdom.ORCID 0000-0002-7579-340X
Tom WaddellDepartment of Medical Oncology, Christie Hospital, Manchester, United Kingdom.
Kate FifeAddenbrooke's Hospital, Cambridge, United Kingdom.
Richard GriffithsThe Clatterbridge Cancer Centre, Liverpool, United Kingdom.ORCID 0000-0003-1538-4935
Anand SharmaMount Vernon Cancer Centre, Middlesex, United Kingdom.ORCID 0000-0003-4161-9398
Eszter KatonaClinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.
Helen HowardClinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.
Galina VelikovaLeeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.ORCID 0000-0003-1899-5942
Anthony MaraveyasCastle Hill Hospital, Hull, United Kingdom.ORCID 0000-0003-4176-5176
Janet BrownDepartment of Oncology and Metabolism, University of Sheffield, Sheffield, United Kingdom.
Carmel PezaroSheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom.
Mark TuthillDepartment of Oncology, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.
Ekaterini BoletiRoyal Free London NHS Foundation Trust, London, United Kingdom.
Amit BahlBristol Haematology and Oncology Centre, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom.
Bernadett SzabadosBarts Cancer Institute, Queen Mary University of London, London, United Kingdom.ORCID 0000-0002-8786-0032
Rosamonde E BanksLeeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.ORCID 0000-0002-0042-8715
Joanne BrownLeeds Institute of Medical Research at St James's, University of Leeds, St James's University Hospital, Leeds, United Kingdom.
Balaji VenugopalInstitute of Cancer Sciences, University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.ORCID 0000-0002-0459-7102
Poulam PatelDivision of Cancer & Stem Cells, School of Medicine, University of Nottingham, Nottingham, United Kingdom.ORCID 0000-0002-1978-4066
Ankit JainThe Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom.
Stefan N SymeonidesEdinburgh Cancer Centre, Western General Hospital, NHS Lothian, Edinburgh, United Kingdom.
Paul NathanMount Vernon Cancer Centre, Middlesex, United Kingdom.ORCID 0000-0002-2327-3250
Fiona J CollinsonClinical Trials Research Unit, University of Leeds, Leeds, United Kingdom.ORCID 0000-0001-6964-6406
Thomas PowlesBarts Cancer Institute, Queen Mary University of London, London, United Kingdom.ORCID 0000-0001-7760-4724
University of Leeds · GBMount Vernon Cancer Centre · GBQueen Mary University of London · GBAddenbrooke's Hospital · GBBeatson West of Scotland Cancer Centre · GBCastle Hill Hospital · GBClatterbridge Cancer Centre NHS Foundation Trust · GBNHS Lothian · GBOxford University Hospitals NHS Trust · GBRoyal Free London NHS Foundation Trust · GBRoyal Marsden Hospital · GBSheffield Teaching Hospitals NHS Foundation Trust · GBThe Christie Hospital · GBThe Royal Wolverhampton NHS Trust · GBUniversity Hospitals Bristol NHS Foundation Trust · GBUniversity of Nottingham · GB

Funding

Cancer Research UK 25447
6 · The paper itself

Abstract

purposeIpilimumab (IPI), in combination with nivolumab (NIVO), is an approved frontline treatment option for patients with intermediate- or poor-risk advanced renal cell carcinoma (aRCC). We conducted a randomized phase II trial to evaluate whether administering IPI once every 12 weeks (modified), instead of once every 3 weeks (standard), in combination with NIVO, is associated with a favorable toxicity profile.

methodsTreatment-naïve patients with clear-cell aRCC were randomly assigned 2:1 to receive four doses of modified or standard IPI, 1 mg/kg, in combination with NIVO (3 mg/kg). The primary end point was the proportion of patients with a grade 3-5 treatment-related adverse event (trAE) among those who received at least one dose of therapy. The key secondary end point was 12-month progression-free survival (PFS) in the modified arm compared with historical sunitinib control. The study was not designed to formally compare arms for efficacy.

resultsBetween March 2018 and January 2020, 192 patients (69.8% intermediate/poor-risk) were randomly assigned and received at least one dose of study drug. The incidence of grade 3-5 trAEs was significantly lower among participants receiving modified versus standard IPI (32.8%

conclusionRates of grade 3-5 trAEs were significantly lower in patients receiving modified versus standard IPI. Although 12-month PFS did not meet the prespecified efficacy threshold compared with historical control, informal comparison of treatment groups did not suggest any reduction in efficacy with the modified schedule.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsHumansIpilimumabNivolumabIpilimumabNivolumab

Identifiers

PMID37931206
PMCPMC10824383
OpenAlexW4388466343

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.