Evidence map›Paper›PMID 31142501›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2019

A Phase I/II Trial of Cetuximab in Combination with Interleukin-12 Administered to Patients with Unresectable Primary or Recurrent Head and Neck Squamous Cell Carcinoma.

Elizabeth L McMichael, Brooke Benner, Lakhvir S Atwal, Nicholas B Courtney, Xiaokui Mo, Melanie E Davis, Amanda R Campbell, Megan C Duggan, Kallan Williams, Kyle Martin and 14 more

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% 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

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Review
  18. Interleukin-12 as an in situ cancer vaccine component: a review.Cancer immunology, immunotherapy : CII · 2022
    Review
  19. Review
  20. Review
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

24 authors at 3 institutions in 1 country.

Elizabeth L McMichaelBiomedical Sciences Graduate Program, College of Medicine, The Ohio State University, Columbus, Ohio.
Brooke BennerBiomedical Sciences Graduate Program, College of Medicine, The Ohio State University, Columbus, Ohio.
Lakhvir S AtwalComprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
Nicholas B CourtneyComprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
Xiaokui MoCenter for Biostatistics, The Ohio State University, Columbus, Ohio.
Melanie E DavisComprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
Amanda R CampbellBiomedical Sciences Graduate Program, College of Medicine, The Ohio State University, Columbus, Ohio.
Megan C DugganBiomedical Sciences Graduate Program, College of Medicine, The Ohio State University, Columbus, Ohio.
Kallan WilliamsComprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
Kyle MartinComprehensive Cancer Center, The Ohio State University, Columbus, Ohio.ORCID 0000-0001-7402-9306
Kala LevineComprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
Gonzalo N Olaverria SalavaggioneComprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
Tiffany NoelComprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
Akaansha GanjuComprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
Sarvani UppatiComprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
Bonnie PaulComprehensive Cancer Center, The Ohio State University, Columbus, Ohio.
Thomas OlenckiDivision of Medical Oncology, Department of Internal Medicine, The Ohio State University, Columbus, Ohio.
Theodoros N TeknosDepartment of Otolaryngology, The Ohio State University, Columbus, Ohio.
Panos SavvidesDepartment of Medicine, Division of Hematology/Oncology, The Ohio State University, Columbus, Ohio.
Susheela TridandapaniDepartment of Internal Medicine, The Ohio State University, Columbus, Ohio.
John C ByrdDepartment of Internal Medicine, Division of Hematology, The Ohio State University, Columbus, Ohio.
Michael A CaligiuriDepartment of Internal Medicine, Division of Hematology, The Ohio State University, Columbus, Ohio.
Stephen V LiuDepartment of Medicine, Lombardi Comprehensive Cancer Center, MedStar Georgetown University Hospital, Washington, D.C.
William E CarsonDivision of Surgical Oncology, Department of Surgery, The Ohio State University, Columbus, Ohio. william.carson@osumc.edu.
The Ohio State University · USGeorgetown University · USOhio State University Hospital · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Jennifer A. Woyach · 1985 to 2026
$132.3M
TWO SIGNAL REQUIREMENT FOR NATURAL KILLER IMMUNITYP01CA095426 · NCI · OHIO STATE UNIVERSITY · PI MUTHUSAMY, NATARAJAN · 2002 to 2016
$29.6M
UM1 Supplement for Early Therapeutic Trials with Phase 2 IntentUM1CA186712 · NCI · OHIO STATE UNIVERSITY · PI SUSANNE M ARNOLD, WILLIAM E. CARSON · 2014 to 2026
$19.3M
Tumor ImmunologyT32CA090223 · NCI · OHIO STATE UNIVERSITY · PI CARSON, WILLIAM E. · 2002 to 2023
$4.1M
NCI NIH HHS P01 CA095426NCI NIH HHS P30 CA016058NCI NIH HHS T32 CA090223NCI NIH HHS UM1 CA186712
6 · The paper itself

Abstract

purposemAbs including cetuximab can induce antibody-dependent cellular cytotoxicity (ADCC) and cytokine production mediated via innate immune cells with the ability to recognize mAb-coated tumors. Preclinical modeling has shown that costimulation of natural killer (NK) cells via the Fc receptor and the IL12 receptor promotes NK-cell-mediated ADCC and production of cytokines. PATIENTS AND

methodsThis phase I/II trial evaluated the combination of cetuximab with IL12 for the treatment of EGFR-expressing head and neck cancer. Treatment consisted of cetuximab 500 mg/m

resultsThe combination of cetuximab and IL12 was well tolerated. No clinical responses were observed, however, 48% of patients exhibited prolonged progression-free survival (PFS; average of 6.5 months). Compared with patients that did not exhibit clinical benefit, patients with PFS >100 days exhibited increased ADCC as therapy continued compared with baseline, greater production of IFNγ, IP-10, and TNFα at the beginning of cycle 8 compared with baseline values and had a predominance of monocytic MDSCs versus granulocytic MDSCs prior to therapy.

conclusionsFurther investigation of IL12 as an immunomodulatory agent in combination with cetuximab in head and neck squamous cell carcinoma is warranted.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCetuximabCytokinesDrug Administration ScheduleFemaleHumansInterleukin-12MaleMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisNeoplasm StagingBiomarkers, TumorCetuximabCytokinesInterleukin-12

Identifiers

PMID31142501
PMCPMC6697573
OpenAlexW2947405510

What OpenQuestion holds

Textmetadata
LicenceTDM
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.