NCT01302496

Autologous TriMix-DC Therapeutic Vaccine in Combination With Ipilimumab in Patients With Previously Treated Unresectable Stage III or IV Melanoma

A Two-stage Phase II Study of Autologous TriMix-DC Therapeutic Vaccine in Combination With Ipilimumab in Patients With Previously Treated Unresectable Stage III or IV Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Bart Neyns · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The CTLA-4 blocking monoclonal antibody ipilimumab (MDX-010, BMS-734016), has demonstrated anti-tumor activity in a subgroup of patients with Stage III (unresectable) or Stage IV melanoma (measurable per modified WHO criteria), who have received prior treatment with any regimen (non-experimental or experimental), except a CD-137 agonist or a CTLA4 inhibitor or agonist and relapsed, failed to respond (CR or PR) or did not tolerate that regimen (Wolchok, Neyns et al. 2009; O'Day, Maio et al. 2010). Ipilimumab exerts its therapeutic effect presumably by activating T-lymphocytes that infiltrate the tumor mass to destroy the malignant cells by mechanisms of cytotoxic cellular interaction. Autologous TriMix-DC vaccine can induce a T-cell repertoire that recognizes in a HLA-restricted way the melanoma associated antigens MAGE-A3, MAGE-C2, tyrosinase and gp100. Administration of ipilimumab together with TriMix-DC vaccine therapy may be a more effective treatment for patients with advanced melanoma as compared to either modality alone.

Conditions

• Malignant Melanoma Stage III
• Malignant Melanoma Stage IV

Interventions

Type	Name	Description
BIOLOGICAL	TriMix-DC and ipilimumab	Patients will receive 5 administrations of autologous TriMix-DC, administrations 2, 3, 4 and 5 will be preceded by ipilimumab (a CTLA-4 blocking monoclonal antibody, at a dose of 10 mg/kg). Patients who are free from progression according to the irRC will be offered ipilimumab maintenance administrations of ipilimumab (10mg/kg q12wks).

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-10-01
• Completion: 2017-01-01
• First posted: 2011-02-24
• Last updated: 2021-03-29

Locations

1 site across 1 country: Belgium