Evidence map›Paper›PMID 32641240›Full record

Trial reportGynecologic oncology2020

Phase II study of axalimogene filolisbac (ADXS-HPV) for platinum-refractory cervical carcinoma: An NRG oncology/gynecologic oncology group study.

Warner K Huh, William E Brady, Paula M Fracasso, Don S Dizon, Matthew A Powell, Bradley J Monk, Charles A Leath, Lisa M Landrum, Edward J Tanner, Erin K Crane and 3 more

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

Trial report in Gynecologic oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01266460 (A Phase II Evaluation of ADXS11-001), which is not on this map. Cited by 42 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 3% 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.

NCT01266460 phase2completednot on this map

A Phase II Evaluation of ADXS11-001 (NSC 752718) in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix

TypeinterventionalSponsorGynecologic Oncology GroupRan2011 to 2018Enrolled54ConditionsCervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Recurrent Cervical CarcinomaArmsAttenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001, Laboratory Biomarker Analysis
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 1 synthesis or guideline pooled it, 74 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. 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

13 authors at 12 institutions in 1 country.

Warner K HuhUniversity of Alabama at Birmingham, Division of Gynecologic Oncology, Birmingham, AL 35249, United States of America. Electronic address: whuh@uabmc.edu.
William E BradyNRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park, Buffalo, NY 14263, United States of America.
Paula M FracassoDepartment of Medicine, University of Virginia, UVA Cancer Center, Charlottesville, VA 22908, United States of America. Electronic address: fracasso@virginia.edu.
Don S DizonDivision of Hematology-Oncology, Lifespan Cancer Institute, Rhode Island Hospital, Department of Medicine, Alpert Medical School of Brown University, Providence, RI 02903, United States of America.
Matthew A PowellWashington University School of Medicine, Saint Louis, MO 63110, United States of America. Electronic address: mpowell@wustl.edu.
Bradley J MonkArizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine at St. Joseph Hospital, Phoenix, AZ 85016, United States of America. Electronic address: Monk@usoncology.com.
Charles A LeathUniversity of Alabama at Birmingham, Division of Gynecologic Oncology, Birmingham, AL 35249, United States of America. Electronic address: cleath@uabmc.edu.
Lisa M LandrumOklahoma University Health Science Center, OB/GYN, Oklahoma City, OK 73104, United States of America. Electronic address: lisa-landrum@ouhsc.edu.
Edward J TannerJohns Hopkins Medical Institutions, Baltimore, MD 21287, United States of America. Electronic address: etanner4@jhmi.edu.
Erin K CraneDepartment of Gynecologic Oncology, Carolinas Medical Center, Levine Cancer Institute, Charlotte, NC 28203, United States of America. Electronic address: erin.crane@atriumhealth.org.
Stefanie UedaUniversity of California, San Francisco, OB/GYN & Reproductive Sciences, Division of Gyn Onc., San Francisco, CA 94115, United States of America. Electronic address: UedaS2@obgyn.ucsf.edu.
Michael T McHaleMoores UCSD Cancer Center, La Jolla, CA 92093, United States of America. Electronic address: mtmchale@ucsd.edu.
Carol AghajanianMemorial Sloan-Kettering Cancer Center, Dept. of Medical Oncology, New York, NY 10021, United States of America. Electronic address: aghajanc@mskcc.org.
University of Alabama at Birmingham · USCarolinas Medical Center · USJohns Hopkins University · USLifespan · USMemorial Sloan Kettering Cancer Center · USMoores Cancer CenterNRG Oncology · USSt. Joseph Hospital · USUniversity of California, San Francisco · USUniversity of Oklahoma Health Sciences Center · USUniversity of Virginia · USWashington University in St. Louis · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
A Lead Academic Participating Site in Oklahoma for the Design and Conduct of NCTN Clinical TrialsUG1CA233193 · NCI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI Muhammad Furqan · 2019 to 2026
$13.7M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
NCTN Deep South Research ConsortiumUG1CA233330 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Charles A. Leath, Andrew M McDonald · 2019 to 2026
$3.7M
Network Lead Academic Participating Site Grant from the Roswell Park Cancer InstituteUG1CA233191 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI LELE, SHASHIKANT, LEVINE, ELLIS G · 2019 to 2025
$3.1M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA233191NCI NIH HHS UG1 CA233193NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233330NCI NIH HHS UG1 CA233339
6 · The paper itself

Abstract

objectiveWomen with persistent, recurrent, and/or metastatic cervical cancer have a poor prognosis. Even with the availability of cisplatin plus paclitaxel and bevacizumab, median overall survival (OS) is only 17.0 months, with median post-progression survival of approximately seven months. We studied the therapeutic vaccine, Axalimogene filolisbac (ADXS-HPV), in women who had progressed following at least one prior line of therapy (Gynecologic Oncology Group protocol 265/NCT01266460).

methodsVolunteers ≥18 years with advanced cervical cancer and GOG performance status score of 0 or 1 were eligible for participation in this 2-stage, phase II trial. In stage 1, women received up to three doses of ADXS-HPV (1 × 10

resultsAmong 50 evaluable volunteers, the 12-month OS was 38% (n = 19). Median OS was 6.1 months (95% CI: 4.3-12.1) and median PFS was 2.8 months (95% CI: 2.6-3.0). The most common treatment-related AEs were fatigue, chills, fever, nausea, and anemia. The majority of AEs were grade 1 or 2 and resolved spontaneously or with appropriate treatment.

conclusionAt the dose and schedule studied, ADXS-HPV immunotherapy was tolerable and met the protocol-specified benchmark for activity required to warrant further investigation in volunteers with cervical carcinoma.

Indexed as

AdultAgedCancer VaccinesDrug Resistance, NeoplasmFemaleHumansListeria monocytogenesMiddle AgedOrganoplatinum CompoundsPapillomavirus E7 ProteinsUterine Cervical NeoplasmsCancer Vaccinesoncogene protein E7, Human papillomavirus type 16Organoplatinum CompoundsPapillomavirus E7 ProteinsHPVImmunotherapyListeriaMetastaticRecurrent cervical cancer

Identifiers

PMID32641240
PMCPMC7487015
OpenAlexW3039580871

What OpenQuestion holds

Textmetadata
LicenceTDM
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.