Evidence map›Paper›PMID 40990036›Full record

Trial reportCPT: pharmacometrics & systems pharmacology2025

Model-Informed Drug Development of Subcutaneous Nivolumab: Comparison of Pharmacokinetic Analysis Methodologies Using Clinical Trial Simulation.

Yue Zhao, Heather Vezina, Zheyi Hu, Anna Kondic, Li Zhu, Amit Roy

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in CPT: pharmacometrics & systems pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04810078 (A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT04810078 phase3active not recruitingnot on this map

A Phase 3, Open-label, Randomized, Noninferiority Trial of Subcutaneous Formulation of Nivolumab Versus Intravenous Nivolumab in Participants With Advanced or Metastatic Clear Cell Renal Cell Carcinoma Who Have Received Prior Systemic Therapy

TypeinterventionalSponsorBristol-Myers SquibbRan2021 to 2027Enrolled681ConditionsClear Cell Renal Cell CarcinomaArmsNivolumab and rHuPH20, Nivolumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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.

Yue ZhaoBristol Myers Squibb, Princeton, New Jersey, USA.ORCID 0000-0002-0814-0134
Heather VezinaBristol Myers Squibb, Princeton, New Jersey, USA.
Zheyi HuBristol Myers Squibb, Princeton, New Jersey, USA.
Anna KondicBristol Myers Squibb, Princeton, New Jersey, USA.ORCID 0009-0005-5642-2960
Li ZhuBristol Myers Squibb, Princeton, New Jersey, USA.
Amit RoyBristol Myers Squibb, Princeton, New Jersey, USA.ORCID 0000-0003-2140-1455

Funding

Bristol Myers Squibb
6 · The paper itself

Abstract

A subcutaneous formulation of nivolumab was evaluated in the phase III study CheckMate 67T (NCT04810078). The co-primary pharmacokinetic exposure endpoints, time-averaged serum concentration over the first 28 days (C

Indexed as

Antineoplastic Agents, ImmunologicalCarcinoma, Renal CellDrug DevelopmentKidney NeoplasmsModels, BiologicalNivolumabAdministration, IntravenousClinical Trials, Phase III as TopicComputer SimulationHumansInjections, SubcutaneousAntineoplastic Agents, ImmunologicalNivolumabmodel‐based drug developmentoncologypharmacokinetics

Identifiers

PMID40990036
PMCPMC12706396

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.