A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors (GIST)

A Study to Evaluate the Safety of Intuvax Administered Intra-tumorally in Patients With Gastrointestinal Stromal Tumors (GIST)

Gastrointestinal Stromal Tumor

Completed

1

Start Date 06/01/2016

Age of Trial (yrs) 8.5

Gleevec-resistant

Immune stimulate

Stimulate the immune system

Specifically GIST and only GIST

EudraCT-no: 2015-002689-22

Immunicum AB

Robert Bränström, MD, PhD +46 8 51779213 robert.branstrom@ki.se Linda Barkemo +46 31 405050 linda.barkemo@immunicum.com

Intravenous

Purpose: The study is a prospective single armed, open label phase I study. Patients with advanced or metastatic GIST and tumor progression despite ongoing treatment with second-line Sunitinib treatment, and with at least one measureable tumor lesion, will be eligible for the study. A maximum of 12 patients will be included in this study. The patients will continue with Sunitinib treatment until the 3 months follow up visit. If further tumor progression Sunitinib will be withdrawn but if stable disease or objective response the patient will continue with Sunitinib until progress. The investigational product Intuvax will be injected into a tumor lesion at two or three treatment occasions; day 1, 14 days (±3 days) after the first vaccination, and 28 days (±3 days) after the second vaccination (patient 7-12 only). Intuvax will be injected in a viable part of the tumor, using ultrasound-guided or CT technique for correct administration.