Evidence map›Paper›PMID 33312760›Full record

ArticleOncoimmunology2020

A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1.

Neeta Somaiah, Sant P Chawla, Matthew S Block, John C Morris, Khanh Do, Joseph W Kim, Mihaela Druta, Kamalesh K Sankhala, Patrick Hwu, Robin L Jones and 11 more

Open access · goldAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Oncoimmunology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 13% 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Antigen-specific active immunotherapy for ovarian cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. NY-ESO-1 antigen: A promising frontier in cancer immunotherapy.Clinical and translational medicine · 2024
    Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Targeting cancer testis antigens in synovial sarcoma.Journal for immunotherapy of cancer · 2021
    Review
  18. Article
  19. Article
  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

21 authors at 14 institutions in 3 countries.

Neeta SomaiahDepartment of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Sant P ChawlaSarcoma Oncology Center, Santa Monica, CA, United States.
Matthew S BlockDepartment of Medical Oncology, Mayo Clinic, Rochester, MN, United States.
John C MorrisDepartment of Medicine, University of Cincinnati College of Medicine, Cincinnati, OH, United States.
Khanh DoMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.
Joseph W KimDepartment of Medical Oncology, Yale School of Medicine, New Haven, CT, United States.
Mihaela DrutaMedical Oncology, Moffitt Cancer Center, Tampa, FL, United States.
Kamalesh K SankhalaHematology/Oncology, Cedars-Sinai Medical Center, Beverly Hills, CA, United States.
Patrick HwuDivision of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Robin L JonesSeattle Cancer Care Alliance, Seattle, WA.
Sacha GnjaticHuman Immune Monitoring Center, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Seunghee Kim-SchulzeHuman Immune Monitoring Center, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Kevin TuballesHuman Immune Monitoring Center, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Mahlet YishakHuman Immune Monitoring Center, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Hailing LuImmune Design Corp., South San Francisco, CA, United States.
Adam YakovichImmune Design Corp., South San Francisco, CA, United States.
Jan Ter MeulenImmune Design Corp., South San Francisco, CA, United States.
Michael ChenImmune Design Corp., South San Francisco, CA, United States.
Richard T KenneyImmune Design Corp., South San Francisco, CA, United States.
Chet BohacImmune Design Corp., South San Francisco, CA, United States.
Seth M PollackClinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.
Icahn School of Medicine at Mount Sinai · USMetis Design Corporation (United States) · USThe University of Texas MD Anderson Cancer Center · USCedars-Sinai Medical Center · USDana-Farber Cancer Institute · USFred Hutch Cancer Center · USMacroGenics (United States) · USMayo Clinic in Arizona · USMoffitt Cancer Center · USRoyal Marsden Hospital · GBSarcoma Oncology Center · USSeagen (United States) · USUniversity of Cincinnati Medical Center · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
High-Dimensional Immune Monitoring of NCI-Supported Immunotherapy TrialsU24CA224319 · NCI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI Sacha Gnjatic, Seunghee Kim-Schulze · 2017 to 2026
$21.5M
NCATS NIH HHS UL1 TR001863NCI NIH HHS U24 CA224319
6 · The paper itself

Abstract

Preclinical data suggest that a "prime-boost" vaccine regimen using a target-expressing lentiviral vector for priming, followed by a recombinant protein boost, may be effective against cancer; however, this strategy has not been evaluated in a clinical setting. CMB305 is a prime-boost vaccine designed to induce a broad anti-NY-ESO-1 immune response. It is composed of LV305, which is an NY-ESO-1 expressing lentiviral vector, and G305, a recombinant adjuvanted NY-ESO-1 protein. This multicenter phase 1b, first-in-human trial evaluated CMB305 in patients with NY-ESO-1 expressing solid tumors. Safety was examined in a 3 + 3 dose-escalation design, followed by an expansion with CMB305 alone or in a combination with either oral metronomic cyclophosphamide or intratumoral injections of a toll-like receptor agonist (glucopyranosyl lipid A). Of the 79 patients who enrolled, 81.0% had sarcomas, 86.1% had metastatic disease, and 57.0% had progressive disease at study entry. The most common adverse events were fatigue (34.2%), nausea (26.6%), and injection-site pain (24.1%). In patients with soft tissue sarcomas, a disease control rate of 61.9% and an overall survival of 26.2 months (95% CI, 22.1-NA) were observed. CMB305 induced anti-NY-ESO-1 antibody and T-cell responses in 62.9% and 47.4% of patients, respectively. This is the first trial to test a prime-boost vaccine regimen in patients with advanced cancer. This approach is feasible, can be delivered safely, and with evidence of immune response as well as suggestion of clinical benefit.

Indexed as

Cancer VaccinesSarcomaAdjuvants, ImmunologicAntigens, NeoplasmHumansMembrane ProteinsAdjuvants, ImmunologicAntigens, NeoplasmCancer VaccinesMembrane ProteinsG305immunotherapylentivirusLV305myxoid liposarcomaNY-ESO-1prime-boostsynovial sarcomavaccine

Identifiers

PMID33312760
PMCPMC7714520
OpenAlexW3107964318

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.