Evidence map›Paper›PMID 34642329›Full record

Trial reportNature communications2021

Phase II study of ipilimumab and nivolumab in leptomeningeal carcinomatosis.

Priscilla K Brastianos, Matthew R Strickland, Eudocia Quant Lee, Nancy Wang, Justine V Cohen, Ugonma Chukwueke, Deborah Anne Forst, April Eichler, Beth Overmoyer, Nancy U Lin and 20 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02939300 (Phase II Trial of Ipilimumab and Nivolumab in Leptomeningeal Metastases), which is not on this map. Cited by 63 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 2 pooled it
9.7field-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.

NCT02939300 phase2completednot on this map

Phase II Trial of Ipilimumab and Nivolumab in Leptomeningeal Metastases

TypeinterventionalSponsorMassachusetts General HospitalRan2018 to 2021Enrolled18ConditionsLeptomeningeal CarcinomatosisArmsNivolumab, Ipilimumab
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 2 syntheses or guidelines pooled it, 90 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. The evolving landscape of leptomeningeal metastases from NSCLC: an international, contemporary, multicenter cohort study.Annals of oncology : official journal of the European Society for Medical Oncology · 2026
    Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article

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

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

30 authors at 2 institutions in 1 country.

Priscilla K Brastianos *Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA. pbrastianos@mgh.harvard.edu.
Matthew R Strickland *Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Eudocia Quant LeeDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.
Nancy WangMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Justine V CohenMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Ugonma ChukwuekeDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.
Deborah Anne ForstMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
April EichlerMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Beth OvermoyerDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.
Nancy U LinDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.
Wendy Y ChenDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.
Aditya BardiaMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.ORCID 0000-0003-4885-1157
Dejan JuricMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.ORCID 0000-0003-2983-7704
Ibiayi Dagogo-JackMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Michael D WhiteMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.ORCID 0000-0002-3855-9243
Jorg DietrichMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Naema NayyarMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.ORCID 0000-0003-3436-8404
Albert E KimMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.ORCID 0000-0003-2359-6209
Christopher Alvarez-BreckenridgeMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Maura MaharMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Joana L MoraMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.ORCID 0000-0002-5913-1107
Brian V NahedMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Pamela S JonesMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Helen A ShihMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Elizabeth R GerstnerMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Anita Giobbie-HurderDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.
Scott L CarterDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.ORCID 0000-0002-8480-1475
Kevin OhMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Daniel P CahillMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.
Ryan J SullivanMassachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.ORCID 0000-0001-5344-6645
Massachusetts General Hospital · USDana-Farber Cancer Institute · US

Funding

Identification of genomic drivers of brain metastases in lung adenocarcinomaR01CA227156 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI BRASTIANOS, PRISCILLA KALIOPI, CARTER, SCOTT · 2018 to 2022
$3.5M
Using MRI and circulating tumor DNA to improve the interpretation of response to immunotherapy and targeted therapy in CNS metastasesR01CA244975 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI BRASTIANOS, PRISCILLA KALIOPI, GERSTNER, ELIZABETH · 2020 to 2024
$3.4M
Identification of genomic drivers of brain metastases in renal cell carcinomaR21CA220253 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI BRASTIANOS, PRISCILLA KALIOPI, CARTER, SCOTT · 2018 to 2019
$421k
NCI NIH HHS R01 CA227156NCI NIH HHS R01 CA244975NCI NIH HHS R21 CA220253
6 · The paper itself

Abstract

Leptomeningeal disease (LMD) is a common complication from solid tumor malignancies with a poor prognosis and limited treatment options. We present a single arm Phase II study of 18 patients with LMD receiving combined ipilimumab and nivolumab until progression or unacceptable toxicity (NCT02939300). The primary end point is overall survival at 3 months (OS3). Secondary end points include toxicity, cumulative time-to-progression at 3 months, and progression-free survival. A Simon two-stage design is used to compare a null hypothesis OS3 of 18% against an alternative of 44%. Median follow up based on patients still alive is 8.0 months (range: 0.5 to 15.9 months). The study has met its primary endpoint as 8 of 18 (OS3 0.44; 90% CI: 0.24 to 0.66) patients are alive at three months. One third of patients have experienced one (or more) grade-3 or higher adverse events. Two patients have discontinued protocol treatment due to unacceptable toxicity (hepatitis and colitis, respectively). The most frequent adverse events include fatigue (N = 7), nausea (N = 6), fever (N = 6), anorexia (N = 6) and rash (N = 6). Combined ipilimumab and nivolumab has an acceptable safety profile and demonstrates promising activity in LMD patients. Larger, multicenter clinical trials are needed to validate these results.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsAdultAgedAnorexiaAntineoplastic Agents, ImmunologicalBrain NeoplasmsColitisExanthemaFatigueFemaleFeverHepatitisHumansIpilimumabMaleMeningeal CarcinomatosisAntineoplastic Agents, ImmunologicalIpilimumabNivolumab

Identifiers

PMID34642329
PMCPMC8511104
OpenAlexW3206464970

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.