NCT00086866

Randomized, Open Phase II Study of Immunization With the Recombinant MAGE-3 Protein Combined With Adjuvant AS02B or AS15 in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

Status unknown Phase 2 Last updated 9 February 2015

What this trial tests

Phase 2 trial testing D1/3-MAGE-3-His fusion protein in Melanoma (Skin) in 165 participants. Status unknown.

Timeline

1 May 2004

Primary endpoint
1 January 2007

Quick facts

Lead sponsor	European Organisation for Research and Treatment of Cancer - EORTC
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Masking	none
Primary purpose	treatment
Enrollment	165
Start date	1 May 2004
Primary completion	1 January 2007
Sites	21 locations across Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom

Drugs / interventions tested

• D1/3-MAGE-3-His fusion protein — full drug profile →
• SB-AS02B adjuvant — full drug profile →
• SB-AS15 adjuvant — full drug profile →

Conditions studied

• Melanoma (Skin) — all drugs for Melanoma (Skin) →

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC — full company profile →

Who can join

18 and older, any sex, with Melanoma (Skin). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Response rate (complete response and partial response) as assessed by RECIST criteria
• Vaccine-related toxicity as assessed by CTCAE v3

Sponsor's own description

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy and comparing them to see how well they work in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dendritic-cell-based therapeutic cancer vaccines.
   Palucka K, Banchereau J. · · 2013 · cited 634× · PMID 23890062 · DOI 10.1016/j.immuni.2013.07.004
2. Immature, Semi-Mature, and Fully Mature Dendritic Cells: Toward a DC-Cancer Cells Interface That Augments Anticancer Immunity.
   Dudek AM, Martin S, Garg AD, Agostinis P. · · 2013 · cited 275× · PMID 24376443 · DOI 10.3389/fimmu.2013.00438
3. The Melanoma-Associated Antigen Family A (MAGE-A): A Promising Target for Cancer Immunotherapy?
   Alsalloum A, Shevchenko JA, Sennikov S. · · 2023 · cited 39× · PMID 36980665 · DOI 10.3390/cancers15061779
4. Targeted Cancer Immunotherapy: Nanoformulation Engineering and Clinical Translation.
   Yu M, Yang W, Yue W, Chen Y. · · 2022 · cited 35× · PMID 36257824 · DOI 10.1002/advs.202204335
5. Future perspectives in melanoma research. Meeting report from the "Melanoma Research: a bridge Naples-USA. Naples, December 6th-7th 2010".
   Ascierto PA, De Maio E, Bertuzzi S, Palmieri G, et al · · 2011 · cited 10× · PMID 21439082 · DOI 10.1186/1479-5876-9-32
6. Advancements in nanomedicines for cancer therapy: targeting molecular signaling pathways, activating immune cells, and using photothermal immunomodulation.
   Deb VK, Mukherjee A, Pathak S, Paul S, et al · · 2026 · PMID 42040777 · DOI 10.3389/fbioe.2026.1775442
7. mRNA and Peptide Vaccines in Melanoma-Current Landscape and Future Direction.
   Qin JJ, Wang Y, Sandhu S. · · 2026 · PMID 41744786 · DOI 10.3390/cells15040344
8. Seventh annual meeting of the Italian Network for Tumor Biotherapy (NIBIT), Siena, 1-3 October 2009.
   Maio M, Nicolay HJ, Ascierto PA, Belardelli F, et al · · 2010 · PMID 20204388 · DOI 10.1007/s00262-010-0832-2