Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma
|ClinicalTrials.gov Identifier: NCT01247623|
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : November 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma||Biological: GV1001||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2012|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247623
|Oslo University Hospital|
|Oslo, Postbox 4953, Norway, 0424|