ProTarget Phase II Study on Targeted Treatment for Advanced Cancer Using Genomic Profiling

What this Trial Is About

Researchers are conducting the ProTarget study, a phase II clinical trial, to evaluate the safety and effectiveness of commercially approved cancer drugs used off-label to target specific DNA changes in advanced cancer. The study focuses on patients whose tumors have particular genomic variants identified through accredited tests. It aims to assess anti-tumor activity or disease stability after 16 weeks of treatment while also monitoring side effects and exploring resistance mechanisms through tumor and blood sample analyses. Participants receive targeted cancer drugs chosen based on their tumors genomic profile. The drugs include Alectinib, Atezolizumab, Avelumab, Axitinib, Erlotinib, combinations like Vemurafenib plus Cobimetinib and Trastuzumab plus Pertuzumab, among others. Treatment begins after confirming eligibility for the selected drug, and the study allows proposals for drug use reviewed by a Molecular Tumor Board if needed. Patients are treated with drugs matched to their cancers genomic markers, with follow-up for toxicity and efficacy. During the study, patients undergo assessments including genomic testing of fresh tumor biopsies and liquid biopsies before and during treatment. Researchers monitor tumor response, progression-free survival, overall survival, treatment duration, and serious side effects. Participation continues under medical supervision, with data collected to understand treatment effects and potential resistance. The trial lasts as long as treatment and follow-up are conducted, involving collaboration across Denmark, the Netherlands, and the USA.

ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling