Evidence map›Paper›PMID 38458639›Full record

ArticleJournal for immunotherapy of cancer2024

Final results of urelumab, an anti-CD137 agonist monoclonal antibody, in combination with cetuximab or nivolumab in patients with advanced solid tumors.

Nikhil I Khushalani, Patrick A Ott, Robert L Ferris, Tina Cascone, Dirk Schadendorf, Dung T Le, Manish R Sharma, Fabrice Barlesi, William Sharfman, Jason J Luke and 9 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
7.1field-weighted citation impact, top 2% 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.

NCT02110082 phase1completednot on this map

A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Cetuximab in Subjects With Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck

TypeinterventionalSponsorBristol-Myers SquibbRan2014 to 2016Enrolled66ConditionsColorectal Cancer, Head and Neck CancerArmsUrelumab, Cetuximab
NCT02253992 phase1 / phase2terminatednot on this map

A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Advanced/Metastatic Solid Tumors and B-cell Non-Hodgkins Lymphoma

TypeinterventionalSponsorBristol-Myers SquibbRan2014 to 2019Enrolled232ConditionsAdvanced Solid Tumors, Advanced B-cell NHLArmsUrelumab, Nivolumab
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
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  5. Overcoming resistance to anti-PD-1/PD-L1 therapy in cancer.Cancer drug resistance (Alhambra, Calif.) · 2026
    Review
  6. Review
  7. Article
  8. Article
  9. EGFR: New Insights on Its Activation and Mutation in Tumor and Tumor Immunotherapy.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
    Review
  10. The next generation of immunotherapies for lung cancers.Nature reviews. Clinical oncology · 2025
    Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Review
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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

19 authors at 10 institutions in 3 countries.

Nikhil I KhushalaniDepartment of Cutaneous Oncology, Moffitt Cancer Center, Tampa, Florida, USA.ORCID 0000-0002-3636-4143
Patrick A OttDana-Farber Cancer Institute, Boston, Massachusetts, USA.ORCID 0000-0002-4253-943X
Robert L FerrisHillman Cancer Center, University of Pittsburgh Medical Center Health System, Pittsburgh, Pennsylvania, USA.ORCID 0000-0001-6605-2071
Tina CasconeUniversity of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Dirk SchadendorfKlinik und Poliklinik für Dermatologie, Venerologie und Allergologie, University Hospital Essen, Essen, Germany.ORCID 0000-0003-3524-7858
Dung T LeJohns Hopkins University, Baltimore, Maryland, USA.
Manish R SharmaUniversity of Chicago, Chicago, Illinois, USA.
Fabrice BarlesiAix-Marseille University, Marseille, France.
William SharfmanJohns Hopkins University, Baltimore, Maryland, USA.
Jason J LukeDepartment of Otolaryngology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.ORCID 0000-0002-1182-4908
Ignacio MeleroCIBERONC, and Clinica Universidad de Navarra, Pamplona, Spain.ORCID 0000-0002-1360-348X
Deanne LathersBristol Meyers Squibb Lawrenceville, Lawrenceville, New Jersey, USA.
Jaclyn NeelyBristol Meyers Squibb Lawrenceville, Lawrenceville, New Jersey, USA.
Satyendra SuryawanshiBristol Meyers Squibb Lawrenceville, Lawrenceville, New Jersey, USA.
Abanti SanyalBoston Scientific, Marlborough, Massachusetts, USA.
James L HollowayBristol Meyers Squibb Lawrenceville, Lawrenceville, New Jersey, USA.
Rasika SuryawanshiBristol Meyers Squibb Lawrenceville, Lawrenceville, New Jersey, USA.
Scott ElyBristol Meyers Squibb Lawrenceville, Lawrenceville, New Jersey, USA.
Neil H SegalMemorial Sloan Kettering Cancer Center, New York, New York, USA segaln@mskcc.org.
Johns Hopkins University · USUniversity of Pittsburgh · USAix-Marseille Université · FRBoston Scientific (United States) · USClinica Universidad de Navarra · ESDana-Farber Cancer Institute · USMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USThe University of Texas MD Anderson Cancer Center · USUniversity of Chicago · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
WILD TYPE P53-BASED ADJUVANT IMMUNOTHERAPY FOR SCCHNP50CA097190 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Greg M. Delgoffe · 2004 to 2026
$49.6M
NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA097190
6 · The paper itself

Abstract

backgroundResistance to immune checkpoint inhibitors and targeted treatments for cancer is common; thus, novel immunotherapy agents are needed. Urelumab is a monoclonal antibody agonist that binds to CD137 receptors expressed on T cells. Here, we report two studies that evaluated urelumab in combination with cetuximab or nivolumab in patients with select, advanced solid tumors.

methodsCA186-018: Patients with metastatic colorectal cancer or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated in a dose-evaluation phase with urelumab 0.1 mg/kg (urelumab-0.1) every 3 weeks (Q3W)+cetuximab 250 mg/m

resultsCA186-018: 66 patients received study treatment. The most frequent treatment-related adverse events (TRAEs) were fatigue (75%; n=3) with urelumab-0.1+cetuximab-250 and dermatitis (45%; n=28) with urelumab-8+cetuximab-250. Three patients (5%) discontinued due to TRAE(s) (with urelumab-8+cetuximab-250). One patient with SCCHN had a partial response (objective response rate (ORR) 5%, with urelumab-8+cetuximab-250).CA186-107: 134 patients received study treatment. Fatigue was the most common TRAE (32%; n=2 with urelumab-3+nivolumab-3; n=1 with urelumab-8+nivolumab-3; n=40 with urelumab-8+nivolumab-240). Nine patients (7%) discontinued due to TRAE(s) (n=1 with urelumab-3+nivolumab-3; n=8 with urelumab-8+nivolumab-240). Patients with melanoma naive to anti-PD-1 therapy exhibited the highest ORR (49%; n=21 with urelumab-8+nivolumab-240). Intratumoral gene expression in immune-related pathways (CD3, CD8, CXCL9, GZMB) increased on treatment with urelumab+nivolumab.

conclusionsAlthough the addition of urelumab at these doses was tolerable, preliminary response rates did not indicate an evident additive benefit. Nevertheless, the positive pharmacodynamics effects observed with urelumab and the high response rate in treatment-naive patients with melanoma warrant further investigation of other anti-CD137 agonist agents for treatment of cancer. TRIAL REGISTRATION NUMBERS: NCT02110082; NCT02253992.

Indexed as

Carcinoma, Non-Small-Cell LungHead and Neck NeoplasmsLung NeoplasmsMelanomaAntibodies, MonoclonalCetuximabHumansNivolumabSquamous Cell Carcinoma of Head and NeckAntibodies, MonoclonalCetuximabNivolumaburelumabClinical Trials as TopicNivolumab

Identifiers

PMID38458639
PMCPMC10921538
OpenAlexW4392594375

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.