Rechercher
image du produit
Lancet Oncology, The

S'abonner

Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial - 01/12/20

Doi : 10.1016/S1470-2045(20)30533-7 
Rodney P Rocconi, ProfMD a, Elizabeth A Grosen, MD b, Sharad A Ghamande, ProfMD c, John K Chan, MD d, Minal A Barve, MD e, f, Jonathan Oh, MD f, Devansu Tewari, MD g, Peter C Morris, MD h, Erin E Stevens, MD i, Justin N Bottsford-Miller, MD i, Min Tang, PhD j, Phylicia Aaron, PhD k, Laura Stanbery, PhD k, Staci Horvath, CCRA n, Gladice Wallraven, CCRA q, Ernest Bognar, BS l, o, r, Luisa Manning, MD k, John Nemunaitis, MD k, ⁎ , David Shanahan, BS m, p, s, Brian M Slomovitz, ProfMD t, u, Thomas J Herzog, ProfMD v, Bradley J Monk, ProfMD w, Robert L Coleman, ProfMD x
a Division of Gynecologic Oncology, University of South Alabama—Mitchell Cancer Institute, Mobile, AL, USA 
b Department of Obstetrics and Gynecology, Cancer Care Northwest, Spokane, WA, USA 
c Section of Gynecologic Oncology, Augusta University, Augusta, GA, USA 
d Division of Gynecologic Oncology, California Pacific/Palo Alto Medical Foundation, Sutter Center Research Institute, San Francisco, CA, USA 
e Department of Oncology, Mary Crowley Cancer Research Centers, Dallas, TX, USA 
f Department of Oncology, Texas Oncology, Dallas, TX, USA 
g Department of Obstetrics and Gynecology, Kaiser Permanente, Irvine, CA, USA 
h Division of Gynecologic Oncology, Nebraska Methodist Hospital, Omaha, NE, USA 
i Department of Gynecologic Oncology, Billings Clinic, Billings, MT, USA 
j Stats Department, StatBeyond Consulting, Irvine, CA, USA 
k Department of Medical Affairs, Gradalis, Carollton, TX, USA 
l Department of CMC Operations, Gradalis, Carollton, TX, USA 
m Management Department, Gradalis, Carollton, TX, USA 
n Department of Site Research, Gradalis, Carollton, TX, USA 
o Department of CMC Operations, Gradalis, Carollton, TX, USA 
p Management Department, Gradalis, Carollton, TX, USA 
q Department of Clinical and Regulatory Operations, Gradalis, Carollton, TX, USA 
r Department of CMC Operations, Gradalis, Carollton, TX, USA 
s Management Department, Gradalis, Carollton, TX, USA 
t Department of Obstetrics and Gynecology, Broward Health, Fort Lauderdale, FL, USA 
u Department of Obstetrics and Gynecology, Florida International University, Miami, FL, USA 
v Department of Obstetrics and Gynecology, University of Cincinnati Cancer Center, Cincinnati, OH, USA 
w Department of Obstetrics and Gynecology, Arizona Oncology, Phoenix, AZ, USA 
x US Oncology Research, The Woodlands, TX, USA 

* Correspondence to: Dr John Nemunaitis, Department of Medical Affairs, Gradalis, Carollton, TX 75006, USA Department of Medical Affairs Gradalis Carollton TX 75006 USA

Summary

Background

Gemogenovatucel-T is an autologous tumour cell vaccine manufactured from harvested tumour tissue, which specifically reduces expression of furin and downstream TGF-β1 and TGF-β2. The aim of this study was to determine the safety and efficacy of gemogenovatucel-T in front-line ovarian cancer maintenance.

Methods

This randomised, double-blind, placebo-controlled, phase 2b trial involved 25 hospitals in the USA. Women aged 18 years and older with stage III/IV high-grade serous, endometrioid, or clear cell ovarian cancer in clinical complete response after a combination of surgery and five to eight cycles of chemotherapy involving carboplatin and paclitaxel, and an Eastern Cooperative Oncology Group status of 0 or 1 were eligible for inclusion in the study. Patients were randomly assigned (1:1) to gemogenovatucel-T or placebo by an independent third party interactive response system after successful screening using randomly permuted block sizes of two and four and stratified by extent of surgical cytoreduction and neoadjuvant versus adjuvant chemotherapy. Gemogenovatucel-T (1 × 107 cells per injection) or placebo was administered intradermally (one per month) for a minimum of four and up to 12 doses. Patients, investigators, and clinical staff were masked to patient allocation until after statistical analysis. The primary endpoint was recurrence-free survival, analysed in the per-protocol population. All patients who received at least one dose of gemogenovatucel-T were included in the safety analysis. The study is registered with ClinicalTrials.gov, NCT02346747.

Findings

Between Feb 11, 2015, and March 2, 2017, 310 patients consented to the study at 22 sites. 217 were excluded. 91 patients received gemogenovatucel-T (n=47) or placebo (n=44) and were analysed for safety and efficacy. The median follow-up from first dose of gemogenovatucel-T was 40·0 months (IQR 35·0–44·8) and from first dose of placebo was 39·8 months (35·5–44·6). Recurrence-free survival was 11·5 months (95% CI 7·5–not reached) for patients assigned to gemogenovatucel-T versus 8·4 months (7·9–15·5) for patients assigned to placebo (HR 0·69, 90% CI 0·44–1·07; one-sided p=0·078). Gemogenovatucel-T resulted in no grade 3 or 4 toxic effects. Two patients in the placebo group had five grade 3 toxic events, including arthralgia, bone pain, generalised muscle weakness, syncope, and dyspnea. Seven patients (four in the placebo group and three in the gemogenovatucel-T group) had 11 serious adverse events. No treatment-related deaths were reported in either of the groups.

Interpretation

Front-line use of gemogenovatucel-T immunotherapy as maintenance was well tolerated but the primary endpoint was not met. Further investigation of gemogenovatucel-T in patients stratified by BRCA mutation status is warranted.

Funding

Gradalis.

Le texte complet de cet article est disponible en PDF.

Plan


© 2020  Elsevier Ltd. Tous droits réservés.
Ajouter à ma bibliothèque Retirer de ma bibliothèque Imprimer
Export

    Export citations

  • Fichier

    •

  • Contenu

    •

Vol 21 - N° 12

P. 1661-1672 - décembre 2020 Retour au numéro
Article précédent Article précédent
  • Pembrolizumab plus GX-188E therapeutic DNA vaccine in patients with HPV-16-positive or HPV-18-positive advanced cervical cancer: interim results of a single-arm, phase 2 trial
  • Jin Won Youn, Soo-Young Hur, Jung Won Woo, Yong-Man Kim, Myong Cheol Lim, Sang Yoon Park, Sang Soo Seo, Jae Hong No, Byoung-Gie Kim, Jae-Kwan Lee, So Jin Shin, Kyungun Kim, Marya F Chaney, Yoon-Jeong Choi, You Suk Suh, Jong Sup Park, Young Chul Sung
| Article suivant Article suivant
  • Essential oncology nursing care along the cancer continuum
  • Annie M Young, Andreas Charalambous, Ray I Owen, Bernard Njodzeka, Wendy H Oldenmenger, Mohammad R Alqudimat, Winnie K W So

Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.

Déjà abonné à cette revue ?

Elsevier s'engage à rendre ses eBooks accessibles et à se conformer aux lois applicables. Compte tenu de notre vaste bibliothèque de titres, il existe des cas où rendre un livre électronique entièrement accessible présente des défis uniques et l'inclusion de fonctionnalités complètes pourrait transformer sa nature au point de ne plus servir son objectif principal ou d'entraîner un fardeau disproportionné pour l'éditeur. Par conséquent, l'accessibilité de cet eBook peut être limitée. Voir plus

Accès rapides

Mon compte

Aide & support

Plateformes Elsevier Masson

Déclaration CNIL

EM-CONSULTE.COM est déclaré à la CNIL, déclaration n° 1286925.

En application de la loi nº78-17 du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés, vous disposez des droits d'opposition (art.26 de la loi), d'accès (art.34 à 38 de la loi), et de rectification (art.36 de la loi) des données vous concernant. Ainsi, vous pouvez exiger que soient rectifiées, complétées, clarifiées, mises à jour ou effacées les informations vous concernant qui sont inexactes, incomplètes, équivoques, périmées ou dont la collecte ou l'utilisation ou la conservation est interdite.
Les informations personnelles concernant les visiteurs de notre site, y compris leur identité, sont confidentielles.
Le responsable du site s'engage sur l'honneur à respecter les conditions légales de confidentialité applicables en France et à ne pas divulguer ces informations à des tiers.

Tout le contenu de ce site: Copyright © 2026 Elsevier, ses concédants de licence et ses contributeurs. Tout les droits sont réservés, y compris ceux relatifs à l'exploration de textes et de données, a la formation en IA et aux technologies similaires. Pour tout contenu en libre accès, les conditions de licence Creative Commons s'appliquent.