NCT01331915: THERAVAC

Phase I/II Study of Therapeutic Vaccination With Escalating Doses of Theravac®, a Proteinic Vector Targeting Dendritic Cells Coupled to a Melanoma Antigen, in Patients With Advanced Metastatic Melanoma.

Status unknown Phase 1/Phase 2 Last updated 8 October 2012

What this trial tests

Phase 1/Phase 2 trial testing Theravac in Melanoma in 23 participants. Status unknown.

Timeline

1 September 2010

Primary endpoint
1 October 2013

Quick facts

Lead sponsor	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	1 September 2010
Primary completion	1 October 2013
Sites	1 location across Belgium

Drugs / interventions tested

• Theravac — full drug profile →

Conditions studied

• Melanoma — all drugs for Melanoma →

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain — full company profile →

Who can join

18 and older, any sex, with Melanoma. 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.

• To analyze the safety and toxicity of increasing doses of Theravac® in patients with advanced metastatic melanoma
  Time frame: the first 3 months of treatment
  The toxicity will be assess after the treatment (3 months) for the first three patients of each group.
• To determine whether these immunizations result in a detectable immune response
  Time frame: Up to 24 weeks
  PBMC will be obtained from the buffy-coat of 500 ml of venous blood or from 100 ml of venous blood collected before and after immunization.

Sponsor's own description

In this phase I study, the investigators want to vaccine with THERAVAC® (an inactivated toxin coupled to melanoma antigen) some patients with advanced metastatic melanoma disease.

The primary objective is to analyze the safety of the inreasing doses of vaccine.

The secondary objective is to document whether this vaccine can induce tumor regression in immunized patients.

Publications & conference data

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

1. Research progress on dendritic cell vaccines in cancer immunotherapy.
   Yu J, Sun H, Cao W, Song Y, et al · · 2022 · cited 130× · PMID 35074008 · DOI 10.1186/s40164-022-00257-2
2. Antigen-specific vaccines for cancer treatment.
   Tagliamonte M, Petrizzo A, Tornesello ML, Buonaguro FM, et al · · 2014 · cited 109× · PMID 25483639 · DOI 10.4161/21645515.2014.973317
3. Trial watch: Peptide vaccines in cancer therapy.
   Vacchelli E, Martins I, Eggermont A, Fridman WH, et al · · 2012 · cited 74× · PMID 23264902 · DOI 10.4161/onci.22428
4. Effects of epithelial to mesenchymal transition on T cell targeting of melanoma cells.
   Woods K, Pasam A, Jayachandran A, Andrews MC, et al · · 2014 · cited 28× · PMID 25566505 · DOI 10.3389/fonc.2014.00367
5. Cell Immunotherapy against Melanoma: Clinical Trials Review.
   Filin IY, Mayasin YP, Kharisova CB, Gorodilova AV, et al · · 2023 · cited 16× · PMID 36768737 · DOI 10.3390/ijms24032413
6. Application of dendritic cell extracellular vesicles as a valid nanoparticle platform for cancer therapies: a narrative review.
   Nezamdoust FV, Nezhad-Mokhtari P, Mirzaahmadi B, Mazloumi Z, et al · · 2026 · PMID 42010708 · DOI 10.1186/s13287-026-05011-7