Evidence map›Paper›PMID 36054490›Full record

ArticleInternational journal of cancer2023

Phase 1 trial of CV301 in combination with anti-PD-1 therapy in nonsquamous non-small cell lung cancer.

Arun Rajan, Jhanelle E Gray, Siddhartha Devarakonda, Ruemu Birhiray, Borys Korchin, Erika Menius, Renee N Donahue, Jeffrey Schlom, James L Gulley

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in International journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02840994 (A Phase 1 Trial of CV301 in Combination With Anti- PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.9field-weighted citation impact, top 23% 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.

NCT02840994 phase1completednot on this map

A Phase 1 Trial of CV301 in Combination With Anti- PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer

TypeinterventionalSponsorBavarian NordicRan2016 to 2020Enrolled24ConditionsNon-small Cell Lung Cancer (NSCLC)ArmsCV301, Pembrolizumab, Nivolumab
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Review
  3. Research progress of MUC1 in genitourinary cancers.Cellular & molecular biology letters · 2024
    Review
  4. Review
  5. Review
  6. [Research Progress of Lung Cancer Vaccines].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2023
    Review
  7. 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

9 authors at 5 institutions in 1 country.

Arun RajanThoracic and Gastrointestinal Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0003-2776-3385
Jhanelle E GrayThoracic Oncology, Moffitt Cancer Center, Tampa, Florida, USA.
Siddhartha DevarakondaMedical Oncology, Washington University School of Medicine, St. Louis, Missouri, USA.
Ruemu BirhirayMedical Oncology, Investigative Clinical Research of Indiana, Indianapolis, Indiana, USA.
Borys KorchinBavarian Nordic, Morrisville, North Carolina, USA.
Erika MeniusBavarian Nordic, Morrisville, North Carolina, USA.
Renee N DonahueLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Jeffrey SchlomLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
James L GulleyLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0002-6569-2912
National Institutes of Health · USBavarian Nordic (United States) · USMoffitt Cancer Center · USUrology of Indiana · USWashington University in St. Louis · US

Funding

Strategies for Cancer Vaccine Development: Preclinical StudiesZIABC010944 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2009 to 2025
$26.6M
Human T Cell Responses to Tumor Antigens for Cancer Vaccine DevelopmentZIABC010598 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2009 to 2025
$19.3M
Anti-PD-L1-TGFb antibody (M7824) in advanced Non-Small Cell Lung CancerZIABC011905 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI RAJAN, ARUN · 2019 to 2025
$817k
CV301 and Anti-PD-1 Therapy in Non-Small Cell Lung CancerZIABC011906 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI RAJAN, ARUN · 2019 to 2025
$176k
Intramural NIH HHS ZIA BC011905
6 · The paper itself

Abstract

CV301, a poxviral-based vaccine, has been evaluated in a phase 1 clinical trial (NCT02840994) and shown to be safe and immunologically active (phase 1a). Preclinical data support a combination of CV301 with programmed death-1 inhibitors, which has been evaluated in the phase 1b part of this trial and is reported here. Patients with advanced nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations received two priming doses of modified vaccinia Ankara-BN-CV301 (MVA) 4 weeks apart, followed by boosting doses of fowlpox-CV301 (FPV) at increasing time intervals for a maximum of 17 doses in combination with nivolumab for cohort 1 (C1) and 15 doses in combination with pembrolizumab for cohort 2 (C2). The primary objective was evaluation of safety and tolerability. Between October 2017 and September 14, 2018, patients were enrolled (C1: 4; median age: 64 years). Mean treatment duration was 332 days in C1 and 289 days in C2. CTCAE ≥grade 3 adverse events (AEs) were observed in four (100%) patients in C1 and three (37.5%) patients in C2. There was one death on trial. Immune-related AEs (irAEs) fulfilling criteria for a dose-limiting toxicity included 1 case of pneumonitis. Among 11 evaluable patients, 1 (9%) had a complete response, 1 (9%) had a partial response and 9 (82%) had stable disease. We conclude that CV301 administered with PD-1 inhibitors is safe and clinically active in patients with advanced NSCLC. The frequency or severity of AEs is not increased, including irAEs for each component of the combination.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsDrug Therapy, CombinationHumansMiddle AgedNivolumabNivolumabimmunotherapynon-small cell lung cancerprogrammed cell death 1 receptorvaccine

Identifiers

PMID36054490
PMCPMC10690498
OpenAlexW4293324884

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.