Evidence map›Paper›PMID 36997799›Full record

ArticleNature medicine2023

Concurrent intrathecal and intravenous nivolumab in leptomeningeal disease: phase 1 trial interim results.

Isabella C Glitza Oliva, Sherise D Ferguson, Roland Bassett, Alexandra P Foster, Ida John, Tarin D Hennegan, Michelle Rohlfs, Jessie Richard, Masood Iqbal, Tina Dett and 27 more

Erratum issued 3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 53 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 3 pooled it
18.6field-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.

NCT03025256 phase1active not recruitingnot on this map

Phase I/Ib Study of Concurrent Intravenous and Intrathecal Nivolumab for Melanoma and Lung Cancer Patients With Leptomeningeal Disease (LMD)

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2018 to 2027Enrolled75ConditionsAcral Lentiginous Melanoma, Central Nervous System Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Leptomeningeal NeoplasmArmsBiospecimen Collection, Computed Tomography, Lumbar Puncture, Magnetic Resonance Imaging, Nivolumab
NCT06462222 phase1 / phase2active not recruitingnot on this mapstarted 2024, after this paper: background citation

Immune Checkpoint Inhibitor Combined With Pemetrexed Intrathecal Injection for Leptomeningeal Metastasis From Solid Tumors: a Phase I/II Study

TypeinterventionalSponsorGuangzhou Medical UniversityRan2024 to 2026Enrolled45ConditionsLeptomeningeal MetastasisArmsToripalimab, pemetrexed
NCT06762080 phase1 / phase2active not recruitingnot on this mapstarted 2025, after this paper: background citation

Intrathecal Administration of PD-1/CTLA-4 Bispecific Antibody Plus Pemetrexed in Patients With Leptomeningeal Metastasis From Solid Tumors: A Phase I/II Study

TypeinterventionalSponsorGuangzhou Medical UniversityRan2025 to 2026Enrolled36ConditionsLeptomeningeal MetastasisArmsCadonilimab (AK104), Pemetrexed (Alimta)
3 · Its place in the literature

Who cites it

53 citing papers in PubMed, 3 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
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  11. Risk factors and clinical outcomes associated with leptomeningeal carcinomatosis in gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
    Article
  12. Article
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  14. Review
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  18. 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
  19. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

37 authors at 2 institutions in 1 country.

Isabella C Glitza Oliva *Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. icglitza@mdanderson.org.ORCID http://orcid.org/0000-0002-4530-7765
Sherise D Ferguson *Department of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Roland BassettDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-4534-2042
Alexandra P FosterDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ida JohnDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Tarin D HenneganDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Michelle RohlfsDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jessie RichardDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Masood IqbalDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Tina DettDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Carol LaceyDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Natalie JacksonDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Theresa RodgersDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Suzanne PhillipsDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sheila DuncanDepartment of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Lauren HayduDepartment of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ruitao LinDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Rodabe N AmariaDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0001-6876-278X
Michael K WongDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Adi DiabDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Cassian YeeDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-4429-7307
Sapna P PatelDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0003-1339-1517
Jennifer L McQuadeDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-2393-2172
Grant M FischerDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Ian E McCutcheonDepartment of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-1638-3400
Barbara J O'BrienDepartment of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Sudhakar TummalaDepartment of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Matthew DebnamDepartment of Neuroradiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Nandita Guha-ThakurtaDepartment of Neuroradiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jennifer A WargoDepartment of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0003-3438-7576
Fernando C L CarapetoDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Courtney W HudgensDepartment of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jason T HuseDepartment of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Michael T TetzlaffDepartment of Pathology, The University of California San Francisco, San Francisco, CA, USA.
Elizabeth M BurtonDepartment of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Hussein A TawbiDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0003-1942-851X
Michael A DaviesDepartment of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID http://orcid.org/0000-0002-0977-0912
The University of Texas MD Anderson Cancer Center · USUniversity of California, San Francisco · 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

There is a critical need for effective treatments for leptomeningeal disease (LMD). Here, we report the interim analysis results of an ongoing single-arm, first-in-human phase 1/1b study of concurrent intrathecal (IT) and intravenous (IV) nivolumab in patients with melanoma and LMD. The primary endpoints are determination of safety and the recommended IT nivolumab dose. The secondary endpoint is overall survival (OS). Patients are treated with IT nivolumab alone in cycle 1 and IV nivolumab is included in subsequent cycles. We treated 25 patients with metastatic melanoma using 5, 10, 20 and 50 mg of IT nivolumab. There were no dose-limiting toxicities at any dose level. The recommended IT dose of nivolumab is 50 mg (with IV nivolumab 240 mg) every 2 weeks. Median OS was 4.9 months, with 44% and 26% OS rates at 26 and 52 weeks, respectively. These initial results suggest that concurrent IT and IV nivolumab is safe and feasible with potential efficacy in patients with melanoma LMD, including in patients who had previously received anti-PD1 therapy. Accrual to the study continues, including in patients with lung cancer. ClinicalTrials.gov registration: NCT03025256 .

Indexed as

Lung NeoplasmsMelanomaAntineoplastic Combined Chemotherapy ProtocolsHumansIpilimumabNivolumabTreatment OutcomeIpilimumabNivolumab

Identifiers

PMID36997799
PMCPMC10115650
OpenAlexW4362458636

What OpenQuestion holds

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LicenceCC BY
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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.