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Advanced CancerPhase 2FINPROVENCT05159245

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

A Phase 2 study testing Alectinib, Cobimetinib and Vismodegib in people with Advanced Cancer and Solid Tumor, run by Helsinki University Central Hospital at 5 sites in Finland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

This is a prospective non-randomized national clinical phase 2 trial that aims to determine the efficacy and toxicity of targeted anticancer drugs or combinations that are approved or under review by EMA, FDA or PMDA and are used for treatment of patients with advanced cancer with a potentially actionable variant as… Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Alectinib, Cobimetinib and Vismodegib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
5 sitesFinland
Study dates
10 Dec 2021to 25 Nov 2026
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (age >18 years) patient with a histologically-confirmed locally advanced or metastatic cancer who is no longer benefitting from standard anti-cancer treatment or for whom no such treatment is available or indicated.
  • ECOG performance status 0-2
  • Patients must have acceptable organ function as defined below. However, specific inclusion/exclusion criteria specified in the drug-specific study manual will take precedence:
  • Absolute neutrophil count ≥ 1.5 x 109/l
  • Hemoglobin > 8.0 mmol/l, without blood transfusion within 7 days
  • Platelets > 75 x 109/l (not applicable for hematological patients)
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  • Total bilirubin < 1.5 x ULN
  • AST and ALT < 3 x institutional ULN (or < 5 x ULN in patients with known hepatic metastases)
  • Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 40 mL/min/1.73 m2
  • Patients must have objectively evaluable or measurable disease (by physical or radiographic examination, according to RECIST v1.1, Lugano, IWG and ELN-AML, IMWG, RANO, GCIG, iRESIST or PCWG3.
  • Results must be available from a tumor molecular profiling. Eligible 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) or immunohistochemistry (IHC). The test may have been performed on the primary tumor or a metastatic lesion, in a diagnostic laboratory or within the context of another commercial platform (eg Foundation Medicine), and must reveal a potentially actionable variant.
  • Patients must have a tumor profile for which treatment with one of the approved (or under revision for approval) targeted anti-cancer drugs included in this study has potential clinical benefit based on preclinical data or clinical information.
  • A new (obtained ≤6 months before inclusion after which no further anti-cancer therapy is allowed) fresh frozen and FFPE tumor biopsy specimen or liquid biopsy for extensive biomarker testing is mandatory before the start of treatment with a targeted agent included in the protocol.
  • Ability to understand and the willingness to sign a written informed consent document and comply to the protocol.
  • 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 adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Male patients should avoid impregnating a female partner. Male 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.

Who cannot join

  • Ongoing toxicity > grade 2, other than alopecia or > grade 1 neuropathy.
  • Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement). Required wash out period prior to starting study treatment is at least two weeks. An exception is made for:
  • Patients suffering from CRPC are allowed to continue androgen deprivation therapy.
  • Medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates). These medications must have been started ≥ 1 week prior to enrollment on this study.
  • Received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 14 days prior to the first dose of study intervention
  • Patient is pregnant or nursing.
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  • Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient is clinically stable and off steroids for at least 4 weeks prior to study initiation. GMB patients apply additional exclusion criteria.
  • Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.
  • Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.
  • Patients with known left ventricular ejection fraction (LVEF) < 45% are not eligible
  • Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment are not eligible
  • Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.
  • For each drug included in this protocol, specific inclusion and exclusion criteria (based on the Package Insert or manufacturers recommendations) may also apply. Drug-specific inclusion and exclusion criteria will take precedence over the inclusion/exclusion criteria listed above.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Tanja Juslin contact

+358405597415

tanja.juslin@hus.fi

5 sites in 1 country

Finland5 sites, 5 recruiting

  • Helsinki University Hospital Comprehensive Cancer Center

    Helsinki, Uusimaa, 00029

    Tanja Juslin

    Katriina Jalkanen, MD, PhD

    Recruiting

  • Kuopio University Hospital

    Kuopio

    Okko Kääriäinen, MD

    Recruiting

  • Oulu University Hospital OYS Cancer Center

    Oulu

    Sanna Iivanainen, MD. PhD.

    Recruiting

  • Tampere University Hospital Department of Oncology

    Tampere

    Minna Tanner, MD, PhD

    Recruiting

  • Turku University Hospital Cancer Centre

    Turku, Southwest Finland

    Erika Alanne, MD, PhD

    Recruiting

Other trials in Finland

About this study

Official title: The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs to Determine the Efficacy in Treatment of Advanced Cancers With a Known Molecular Profile

This is a prospective non-randomized national clinical phase 2 trial that aims to determine the efficacy and toxicity of targeted anticancer drugs or combinations that are approved or under review by EMA, FDA or PMDA and are used for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic, RNA-molecular or protein expression test.

Read the detailed description

This is a prospective non-randomized clinical trial that aims to determine the efficacy and toxicity of targeted anticancer drugs or combinations that are approved or under review by EMA, FDA or PMDA and are used for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic, RNA-molecular or protein expression test. The study also aims to facilitate patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing and further deeper analysis on tumor biopsies and/or liquid biopsies for biomarker analyses and resistance mechanisms. Eligible patients have an advanced cancer for which standard treatment options no longer exist and acceptable performance status and organ function. A tumour DNA, RNA or protein expression analysis is required and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Molecular profiling will be utilized to determine an appropriate drug(s) from among those available in the protocol. Drug selection will be guided by a list of potential profiles, the molecular tumor board and databases of identified targets for review and approval of the recommended treatment. The protocol-specified treatment will be administered to the patient once any drug- and disease specific eligibility criteria and overall study criteria are met. Data for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment will be collected for all patients receiving treatment within the trial. In addition, treatment related toxicity will be collected according to CTCAE 5.0.

Being tested
Alectinib, Cobimetinib, Vismodegib, Trastuzumab+Pertuzumab, Entrectinib
Keywords
DRUP study
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlectinibDrug

    Also called Alecensa

    ALK

  • CobimetinibDrug

    Also called Cotellic

    MEK1, MEK2

  • VismodegibDrug

    Also called Erivedge

    Hedgehog

  • Trastuzumab+PertuzumabDrug

    Also called Phesgo

    HER2

  • EntrectinibDrug

    Also called Rozlytrek

    NTRK/ ROS1, ALK

  • AtezolizumabDrug

    Also called Tecentriq

    PD-L1

  • VemurafenibDrug

    Also called Zelboraf

    BRAF V600

  • RegorafenibDrug

    Also called Stivarga

    KIT/BRAF, RET

  • ApalutamideDrug

    Also called Erleada

    AR

  • AbemaciclibDrug

    Also called Verzenio

    CDK4/6

  • TepotinibDrug

    Also called Tepmetko

    MET ex14

  • DabrafenibDrug

    Also called Tafinlar

    RAF

  • TrametinibDrug

    Also called Mekinist

    MEK1, MEK2

  • Dabrafenib+TrametinibDrug

    Also called Tafinlanr+Mekinist

    RAF, MEK1, MEK2

  • PemigatinibDrug

    Also called Pemazyre

    FGFR2

Study groups in NCT05159245
Study groupRoleWhat they receive
AlectinibExperimentalFor patients with a molecular tumor profile that can potentially be targeted by alectinib.
Receives: Drug: Alectinib
CobimetinibExperimentalFor patients with a molecular tumor profile that can potentially be targeted by cobimetinib.
Receives: Drug: Cobimetinib
VismodegibExperimentalFor patients with a molecular tumor profile that can potentially be targeted by vismodegib.
Receives: Drug: Vismodegib
Trastuzumab+PertuzumabExperimentalFor patients with a molecular tumor profile that can potentially be targeted by trastuzumab+pertuzuma combination.
Receives: Drug: Trastuzumab+Pertuzumab
EntrectinibExperimentalFor patients with a molecular tumor profile that can potentially be targeted by entrectinib.
Receives: Drug: Entrectinib
AtezolizumabExperimentalFor patients with a molecular tumor profile that can potentially be targeted by atezolizumab.
Receives: Drug: Atezolizumab
VemurafenibExperimentalFor patients with a molecular tumor profile that can potentially be targeted by vemurafenib.
Receives: Drug: Vemurafenib
RegorafenibExperimentalFor patients with a molecular tumor profile that can potentially be targeted by regorafenib.
Receives: Drug: Regorafenib
ApalutamideExperimentalFor patients with a molecular tumor profile that can potentially be targeted by apalutamide.
Receives: Drug: Apalutamide
AbemaciclibExperimentalFor patients with a molecular tumor profile that can potentially be targeted by abemaciclib.
Receives: Drug: Abemaciclib
TepotinibExperimentalFor patients with a molecular tumor profile that can potentially be targeted by tepotinib.
Receives: Drug: Tepotinib
DabrafenibExperimentalFor patients with a molecular tumor profile that can potentially be targeted by dabrafenib.
Receives: Drug: Dabrafenib
TrametinibExperimentalFor patients with a molecular tumor profile that can potentially be targeted by trametinib.
Receives: Drug: Trametinib
Dabrafenib+TrametinibExperimentalFor patients with a molecular tumor profile that can potentially be targeted by dabrafenib+trametinib combination.
Receives: Drug: Dabrafenib+Trametinib
PemigatinibExperimentalFor patients with a molecular tumor profile that can potentially be targeted by pemigatinib.
Receives: Drug: Pemigatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease control rate

    Disease control rate at 16 weeks after treatment initiation (defined as patients by CR, PR, SD)

    Measured: 16 weeks

Secondary outcomes (5)

  1. Duration of treatment

    Time on drug

    Measured: 5 years

  2. Adverse Events

    Treatment-related grade ≥3 and serious adverse events

    Measured: 5 years

  3. Overall response

    Best overall response (defined as patients by CR, PR, SD)

    Measured: 5 years

  4. PFS

    Progression free survival

    Measured: 5 years

  5. OS

    Overall survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start10 Dec 2021
  3. Primary completion25 Nov 2026 (estimated)
  4. Study completion25 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05159245
Sponsor's protocol ID
FINPROVE
Acronym
FINPROVE
Status last verified
Jul 2024
First submitted
3 Dec 2021
Last updated
15 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Investigators plan to share the clinical study report.

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