Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Mini Oral - Melanoma and other skin tumours

1078MO - MIND-DC: A randomized phase III trial to assess the efficacy of adjuvant dendritic cell vaccination in comparison to placebo in stage IIIB and IIIC melanoma patients

Date

18 Sep 2020

Session

Mini Oral - Melanoma and other skin tumours

Presenters

Kalijn Bol

Citation

Annals of Oncology (2020) 31 (suppl_4): S672-S710. 10.1016/annonc/annonc280

Authors

K. Bol1, M. Bloemendal1, W. van Willigen2, G. Schreibelt1, S. Hins-de Bree1, A. de Goede3, A.A.M. Van der Veldt4, C. Figdor1, J.W.B. de Groot5, J. de Wilt6, J. Textor7, W.R. Gerritsen8, J. De Vries9

Author affiliations

  • 1 Department Of Tumor Immunology, Radboud University Medical Centre Nijmegen, 6500 HB - Nijmegen/NL
  • 2 Department Of Medical Oncology, Radboud University Medical Centre Nijmegen, 6525 GA - Nijmegen/NL
  • 3 Department Of Pharmacy, Radboud University Medical Centre Nijmegen, 6500 HB - Nijmegen/NL
  • 4 Department Of Medical Oncology, Erasmus University Medical Center, 3015 CE - Rotterdam/NL
  • 5 Department Of Medical Oncology, Isala, Zwolle/NL
  • 6 Department Of Surgical Oncology, Radboud University Medical Centre Nijmegen, Nijmegen/NL
  • 7 Department Of Tumor Immunology, Radboud University Medical Centre Nijmegen, Nijmegen/NL
  • 8 Department Of Medical Oncology, Radboud University Medical Centre Nijmegen, 6691HM - Nijmegen/NL
  • 9 Department Of Tumor Immunology, Radboud University Medical Centre Nijmegen, 6525 GA - Nijmegen/NL
More

Resources

Login to access the resources on OncologyPRO.

Abstract 1078MO

Background

Dendritic cells (DCs) are highly specialized antigen-presenting cells which are essential for the activation of immune responses. Autologous DCs, directly isolated from peripheral blood, loaded with tumor antigens and matured in vitro, can induce tumor-specific immune responses and clinical responses in cancer patients.

Methods

In this phase III clinical trial, patients with resected stage IIIB or IIIC cutaneous melanoma (AJCC 7th edition) were randomized in a 2:1 ratio to adjuvant treatment with DC vaccination or placebo. The active treatment arm consisted of intranodal injections with autologous CD1c+ myeloid DCs and plasmacytoid DCs loaded with tumor antigens (gp100, tyrosinase, MAGE-C2, MAGE-A3 and NY-ESO-1). When adjuvant treatment with anti-PD1 antibodies became available in the Netherlands in November 2018, accrual was stopped prematurely after inclusion of 151 patients. The primary endpoint is the 2-year recurrence-free survival (RFS) rate. Secondary endpoints include overall survival, immunological response and safety.

Results

In January 2020, we performed a preplanned interim analysis. At that time, 102 patients reached mature data for primary endpoint analysis (recurrence of disease within 2 years of randomisation or at least 2-year follow-up). Thirty-eight percent of patients were female and the median age at start was 55.7 years (range 27-78). At inclusion, 51% of patients had stage IIIB disease and 49% stage IIIC disease. Two-year RFS rate was 21.4% in the treatment arm and 25% in the control arm (HR 1.05; 95% CI: 0.47-3.23), providing no statistically significant evidence of a treatment effect (p=0.67).

Conclusions

Our phase III clinical trial with adjuvant DC vaccination in stage IIIB and IIIC melanoma patients showed no benefit over placebo in terms of 2-year RFS. Correlative analysis of skin-test infiltrating lymphocytes for markers of immunological and clinical response are ongoing.

Clinical trial identification

NCT02993315.

Editorial acknowledgement

Legal entity responsible for the study

Radboud University Medical Centre Nijmegen.

Funding

ZonMw, Ministry of Health, Welfare and Sport (VWS), Miltenyi Biotec (in-kind).

Disclosure

A.A.M. Van der Veldt: Advisory/Consultancy: MSD; Advisory/Consultancy: BMS; Advisory/Consultancy: Roche; Advisory/Consultancy: Novartis; Advisory/Consultancy: Eisai; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Sanofi. J.W.B. de Groot: Advisory/Consultancy: BMS; Advisory/Consultancy: MSD; Advisory/Consultancy: Novartis; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Servier. W.R. Gerritsen: Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy: BMS; Advisory/Consultancy: IMS Health; Advisory/Consultancy: IQVIA; Advisory/Consultancy, Research grant/Funding (institution): Janssen-Cilag; Advisory/Consultancy, Research grant/Funding (institution): Sanofi; Research grant/Funding (institution): Astellas; Research grant/Funding (institution): Bayer. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.