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

ConditionsCancerTumorsNeoplasmsNeoplasia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUlrik Lassen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient (age≥ 18 years) with a histologically-proven locally advanced or metastatic malignant disease who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the investigator, no such treatment is available or indicated.

ECOG performance status 0-2

Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/

Disqualifiers

Absolute neutrophil count ≥ 1500 µl

Hemoglobin > 5.6 mmol/l

Platelets > 75,000/µl

Total bilirubin < 1.5 x institutional upper limit of normal (ULN)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alectinib

    Drug

    Alectinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Alectinib might be expected based on their molecular tumor profile.

  • Atezolizumab

    Drug

    Atezolizumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Atezolizumab might be expected based on their molecular tumor profile.

  • Avelumab

    Drug

    Avelumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Avelumab might be expected based on their molecular tumor profile.

  • Axitinib

    Drug

    Axitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Axitinib might be expected based on their molecular tumor profile.

  • Erlotinib

    Drug

    Erlotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Erlotinib might be expected based on their molecular tumor profile.

  • Vemurafenib plus Cobimetinib (combination)

    Drug

    Vemurafenib plus Cobimetinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Vemurafenib plus Cobimetinib might be expected based on their molecular tumor profile.

  • Trastuzumab plus Pertuzumab (combination)

    Drug

    Trastuzumab plus Pertuzumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Trastuzumab plus Pertuzumab might be expected based on their molecular tumor profile.

  • Trastuzumab emtansine

    Drug

    Trastuzumab emtansine treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Trastuzumab emtansine might be expected based on their molecular tumor profile.

  • Vismodegib

    Drug

    Vismodegib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Vismodegib might be expected based on their molecular tumor profile.

  • Niraparib

    Drug

    Niraparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Niraparib might be expected based on their molecular tumor profile.

Treatment groups

300 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: AlectinibExperimental treatment 1 intervention
Group B: AtezolizumabExperimental treatment 1 intervention
Group C: AvelumabExperimental treatment 1 intervention
Group D: AxitinibExperimental treatment 1 intervention
Group E: ErlotinibExperimental treatment 1 intervention
Group F: Vemurafenib plus Cobimetinib (combination)Experimental treatment 1 intervention
Group G: Trastuzumab plus Pertuzumab (combination)Experimental treatment 1 intervention
Group H: Trastuzumab emtansinExperimental treatment 1 intervention
Group I: VismodegibExperimental treatment 1 intervention
Group J: NiraparibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Response rate

Response according to RECIST

Time frame
16 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ulrik Lassen

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Roche Pharma AG

Collaborator

Pfizer

Collaborator

GlaxoSmithKline

Collaborator

Source ClinicalTrials.gov
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