A Clinical Study to Evaluate Safety and Immunologic Response of COMBIG-DC, in Patients With Metastatic Kidney Cancer

Summary

The primary objective of this study is to answer the question "Is it possible to inject the Combig-DC vaccine in a renal tumour without getting unacceptable side effects"? Patients newly diagnosed with metastatic renal cell carcinoma will get Combig-DC vaccinations at two occasions in a two weeks period (day 1 and day 14). After another two weeks the kidney will be eliminated. Adverse events will be registered, as well as changes in vital signs(heart rate, blood pressure and body temperature) and lab parameters. Immunologic response will be evaluated by measuring immunologic markers in blood and tumour tissue, and measuring the size of the metastases three months after nephrectomy.

Timeline

Start

2012-02

Primary completion

2013-12

Completion

2013-12

Publications

• Laurell A, Lonnemark M, Brekkan E, Magnusson A, Tolf A, Wallgren AC, Andersson B, Adamson L, Kiessling R, Karlsson-Parra A. Intratumorally injected pro-inflammatory allogeneic dendritic cells as immune enhancers: a first-in-human study in unfavourable risk patients with metastatic renal cell carcinoma. J Immunother Cancer. 2017 Jun 20;5:52. doi: 10.1186/s40425-017-0255-0. eCollection 2017.

Drugs

Indications