ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling
ProTarget
1 other identifier
interventional
300
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cancer
Started Aug 2020
Longer than P75 for phase_2 cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2020
CompletedFirst Posted
Study publicly available on registry
April 10, 2020
CompletedStudy Start
First participant enrolled
August 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2030
July 25, 2025
July 1, 2025
8.7 years
April 8, 2020
July 22, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Response rate
Response according to RECIST
16 weeks
Study Arms (10)
Alectinib
EXPERIMENTALAlectinib for patients with a molecular tumor profile that can potentially be targeted by Alectinib.
Atezolizumab
EXPERIMENTALAtezolizumab for patients with a molecular tumor profile that can potentially be targeted by Atezolizumab.
Avelumab
EXPERIMENTALAvelumab for patients with a molecular tumor profile that can potentially be targeted by Avelumab.
Axitinib
EXPERIMENTALAxitinib for patients with a molecular tumor profile that can potentially be targeted by Axitinib.
Erlotinib
EXPERIMENTALErlotinib for patients with a molecular tumor profile that can potentially be targeted by Erlotinib.
Vemurafenib plus Cobimetinib (combination)
EXPERIMENTALVemurafenib plus Cobimetinib (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Vemurafenib plus Cobimetinib.
Trastuzumab plus Pertuzumab (combination)
EXPERIMENTALTrastuzumab plus Pertuzumab (combination treatment) for patients with a molecular tumor profile that can potentially be targeted by Trastuzumab plus Pertuzumab.
Trastuzumab emtansin
EXPERIMENTALTrastuzumab emtansin for patients with a molecular tumor profile that can potentially be targeted by Trastuzumab emtansin.
Vismodegib
EXPERIMENTALVismodegib for patients with a molecular tumor profile that can potentially be targeted by Vismodegib.
Niraparib
EXPERIMENTALNiraparib for patients with a molecular tumor profile that can potentially be targeted by Niraparib.
Interventions
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 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 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 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 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 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 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 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 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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- AST (SGOT) and ALT(SGPT) \< 2.5 x institutional upper limit of normal (ULN) (or \< 5 x ULN in patients with known hepatic metastases)
- Calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2.
- Patients must have measurable or evaluable disease (per RECIST v1.1 for solid tumor), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or a subcutaneous or superficial lesion that can be measured with calipers by clinical exam. For lymph nodes, the short axis must be ≥15 mm. Patients who have assessable disease by physical or radiographic examination but do not meet these definitions of measurable disease are eligible and will be considered to have evaluable disease. Patient's whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only) are NOT eligible, with the exception of CA-125 for ovarian cancer and PSA for prostate cancer.
- Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a laboratory accredited by the competent local regulatory authority. The genomic or IHC test used to qualify a patient for participation in ProTarget may have been performed on any specimen of the patient's tumor obtained at any point during the patient's care at the discretion of the patient's treating physician. Genomic assays performed on cell-free DNA in plasma ("liquid biopsies") will also be acceptable if the genomic analysis is performed in a laboratory accredited by the competent local regulatory authority.
- A new biopsy must be performed if possible, for central confirmation by WGS (the result may be awaited and is not required before first dosing).
- Note: Eligible genomic tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), comparative genomic hybridization (CGH), next generation sequencing (NGS), whole exome sequencing (WES). The test may have been performed on a fresh (frozen or in RNA-later) or paraffin-embedded specimen of the primary tumor or a metastatic deposit or on cell free DNA derived from plasma, as determined by the treating physician, and must reveal a potentially actionable genomic variant as defined in Section 5.0, or protein overexpression by IHC.
- Ability to understand and the willingness to sign a written informed consent/assent document
- Have a tumor genomic profile for which treatment with one of the approved targeted anti-cancer therapies included in this study has potential clinical benefit based on the criteria described in Section 7.0.
- For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
- Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) in combination with inhibition of ovulation (intrauterine device (IUD), intrauterine hormone-releasing system ( IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence) for the duration of study participation, and for four to 24 months following completion of study therapy (depending on SPC from individual drugs). Should a woman become pregnant or suspect she is pregnant while participating in this study or if she is the partner of a male participant in this study and becomes pregnant while he is participating in this study, she should inform her or her partner's treating physician immediately as well as her obstetrician. Female study patients who become pregnant must immediately discontinue treatment with any study therapy. Male patients should avoid impregnating a female partner. Male study patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse.
- Ongoing toxicity \> CTCAE grade 2, other than peripheral neuropathy, related to anti-tumor treatment that was completed within 4 weeks prior to registration. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ulrik Lassenlead
- Roche Pharma AGcollaborator
- Pfizercollaborator
- GlaxoSmithKlinecollaborator
Study Sites (7)
Aalborg University Hospital
Aalborg, Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus, Aarhus, 8200, Denmark
Rigshospitalet
Copenhagen, Copenhagen, 2100, Denmark
Herlev Hospital
Herlev, Herlev, 2730, Denmark
Odense University Hospital
Odense, Odense, 5000, Denmark
Zealand University Hospital
Roskilde, Roskilde, 4000, Denmark
Vejle Sygehus
Vejle, Vejle, 7100, Denmark
Related Publications (1)
Kringelbach T, Hojgaard M, Rohrberg K, Spanggaard I, Laursen BE, Ladekarl M, Haslund CA, Harslof L, Belcaid L, Gehl J, Sondergaard L, Eefsen RL, Hansen KH, Kodahl AR, Jensen LH, Holt MI, Oellegaard TH, Yde CW, Ahlborn LB, Lassen U. ProTarget: a Danish Nationwide Clinical Trial on Targeted Cancer Treatment based on genomic profiling - a national, phase 2, prospective, multi-drug, non-randomized, open-label basket trial. BMC Cancer. 2023 Feb 22;23(1):182. doi: 10.1186/s12885-023-10632-9.
PMID: 36814246DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, MD, PhD
Study Record Dates
First Submitted
April 8, 2020
First Posted
April 10, 2020
Study Start
August 24, 2020
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
April 30, 2030
Last Updated
July 25, 2025
Record last verified: 2025-07