OncoMatch/Clinical Trials/NCT04341181
ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling
Is NCT04341181 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for cancer.
Treatment: Alectinib · Atezolizumab · Avelumab · Axitinib · Erlotinib · Vemurafenib plus Cobimetinib (combination) · Trastuzumab plus Pertuzumab (combination) · Trastuzumab emtansine · Vismodegib · Niraparib — The ProTarget study is a phase II, prospective, non-randomized clinical trial with the primary purpose of investigating the safety and efficacy of commercially available cancer drugs that target specific changes in cancer cell DNA to treat patients with advanced cancer. The primary endpoint is anti-tumor activity or stable disease documented after 16 weeks of experimental drug treatment. The drugs used in the trial have been approved by EMA/FDA for the treatment of certain cancers. Choice of drug is based on whether the patient's cancer cells contain precisely the DNA change (i) targeted by the EMA/FDA-approved drug or (ii) related to sensitivity to the EMA/FDA-approved drug. The trial drug is thus not approved by the EMA/FDA or in Denmark for the treatment of the patient's cancer - it is so-called "off-label use". The secondary purposes are: * To detect side effects in patients treated with commercially available targeted cancer drugs. * Performing biomarker analyzes, including (but not limited to) whole-genome analysis (WGS) on a fresh tumor tissue sample (biopsy) at baseline and progression. * To investigate mechanisms of resistance using recurrent / serial fresh tumor biopsies for WGS and so-called liquid biopsies, which are blood samples in which the cancer cell DNA is analyzed. The secondary endpoints include response duration, progression-free survival, and overall survival.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: selected study drug for the same malignancy
Previous treatment with the selected study drug for the same malignancy
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1500/µl; Hemoglobin > 5.6 mmol/l; Platelets > 75,000/µl
Kidney function
Calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
Liver function
Total bilirubin < 1.5 x institutional ULN; AST (SGOT) and ALT (SGPT) < 2.5 x ULN (or < 5 x ULN in patients with known hepatic metastases)
Cardiac function
No preexisting cardiac conditions including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure; LVEF ≥ 40%
Absolute neutrophil count ≥ 1500 µl; Hemoglobin > 5.6 mmol/l; Platelets > 75,000/µl; Total bilirubin < 1.5 x institutional ULN; AST (SGOT) and ALT(SGPT) < 2.5 x institutional ULN (or < 5 x ULN in patients with known hepatic metastases); Calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2. Patients with preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible. Patients with left ventricular ejection fraction (LVEF) known to be < 40% are not eligible.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify