NCT01247623

Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

Primary objective: Determination of safety and tolerability of GV1001 administration combined with Temozolomide (based on blood samples and adverse events). Feasibility of combining active immunisation with Temozolomide treatment. Determination of immunological response after administration of GV1001 and Temozolomide as measured by presence of DTH skin test reaction and specific T-cell responses. Secondary: Evaluation of objective tumour response The trial is an exploratory study which main objective is to estimate safety and feasibility of combining active immunisation with chemotherapy. However, the trial may also indicate the efficacy of the combination.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	GV1001

Timeline

• Start date: 2005-01-01
• Primary completion: 2011-09-01
• Completion: 2012-09-01
• First posted: 2010-11-24
• Last updated: 2014-11-05

Locations

1 site across 1 country: Norway