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Study of Drug Combination for Advanced Cancer Patients with Known Molecular Profile - FINPROVE Study

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial studies the effectiveness of targeted anti-cancer drugs in patients with advanced cancer. The study aims to evaluate how well different medications work in treating cancers that have specific molecular profiles. The medications being tested include pemigatinib, trastuzumab, pertuzumab, vismodegib, apalutamide, abemaciclib, trametinib, atezolizumab, dabrafenib, entrectinib, olaparib, alectinib, regorafenib, vemurafenib, and tepotinib.

The study involves patients whose cancers have specific genetic changes that can be targeted by these medications. Before starting treatment, patients must undergo molecular testing of their tumor to determine if they have genetic changes that might make the treatment effective. This testing may include various methods such as fluorescence in situ hybridization, polymerase chain reaction, next generation sequencing, or immunohistochemistry.

The main goal is to measure how well patients respond to treatment after 16 weeks. Researchers will track how long the treatment works, monitor side effects, measure tumor response, and evaluate how long patients survive without their cancer getting worse. The study will also look at overall survival rates. Treatment will continue as long as patients are benefiting from it and not experiencing unacceptable side effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your cancer tissue will be tested to determine its molecular profile using specialized laboratory tests like FISH, PCR, CGH, NGS, or IHC

    A fresh tissue sample (biopsy) or blood sample will be collected for detailed testing. If a new biopsy is not safe to obtain, previously collected tissue may be used

    Your overall health and organ function will be evaluated through blood tests and physical examination

  2. Step 2

    Treatment assignment

    Based on your cancer's molecular profile, you will be assigned to receive one of the targeted anti-cancer medications

    The medication may be given as tablets, capsules, injections, or infusions depending on the specific drug assigned

  3. Step 3

    Treatment period

    You will receive the assigned medication for as long as it provides benefit

    Regular evaluations will occur to monitor your response to treatment

    The first major evaluation of treatment effectiveness will take place at 16 weeks after starting treatment

  4. Step 4

    Monitoring and follow-up

    Your cancer's response to treatment will be measured using imaging scans

    Side effects will be monitored and recorded, particularly any serious reactions

    Blood tests will be performed regularly to check organ function

    Treatment will continue until the cancer progresses or side effects become unmanageable

  5. Step 5

    Study completion

    The study is planned to continue until December 2026

    After completing treatment, you will need to use effective birth control for 4 months

    Your survival and cancer status will continue to be monitored

Who can join the trial?

14 criteria

  • Must be at least 18 years old with confirmed advanced or metastatic cancer that is no longer responding to standard treatment, or when no standard treatment is available
  • Women who can become pregnant and men must use effective birth control (hormonal or barrier methods) or practice abstinence during the study and for 4 months after completing treatment
  • Must have an ECOG performance status of 0-2 (a scale measuring a person's ability to perform daily activities and self-care)
  • Must have adequate organ function, including:
    • Sufficient white blood cell count
    • Adequate hemoglobin levels
    • Acceptable platelet count (except for blood cancer patients)
    • Normal liver function tests
    • Adequate kidney function
    • Must have cancer that can be measured or evaluated through physical examination, imaging, or laboratory tests
    • Must have results from tumor molecular testing (special tests that examine genetic changes in the tumor)
    • Must have a tumor profile that suggests potential benefit from one of the targeted treatments in the study
    • Must provide a new tumor sample (taken within 6 months before starting the study) or a liquid biopsy (blood test that looks for cancer cells or cancer DNA)
    • Must be able to understand and sign an informed consent form
    • For treatments taken by mouth, must be able to swallow pills and have no problems absorbing medications

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 64 years
  • Any known allergies to the study medications
  • Participation in other clinical trials within the last 30 days
  • Presence of brain metastases (cancer that has spread to the brain)
  • Severe heart conditions or cardiovascular disease (heart and blood vessel problems)
  • Severe kidney or liver dysfunction
  • Active or uncontrolled infections
  • History of other cancers within the past 5 years (except for successfully treated non-melanoma skin cancer)
  • Pregnancy or breastfeeding
  • Unable to follow study procedures or attend scheduled visits
  • Major surgery within 4 weeks before starting the study
  • Immunodeficiency (weakened immune system) or active autoimmune diseases
  • Mental conditions that could interfere with study participation
  • Life expectancy less than 16 weeks
  • Uncontrolled high blood pressure
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Investigated drugs

  • Verzenios

    is an oral medicine that blocks proteins called CDK4 and CDK6, which help cancer cells grow. It is used for certain types of breast cancer that have specific genetic changes.

  • Tecentriq

    is given by IV infusion and works as an immunotherapy. It helps the body’s immune system recognize and attack cancer cells by blocking a protein called PD‑L1.

  • Alecensa

    is an oral pill that blocks a protein called ALK, which can drive the growth of some lung cancers. By stopping ALK, the drug helps slow or stop tumor growth.

  • Erivedge

    is an oral medication that blocks the hedgehog signaling pathway, a route that some skin cancers use to grow. It is used mainly for advanced basal cell carcinoma.

  • Iclusig

    is an oral drug that blocks the BCR‑ABL protein, which is abnormal in certain leukemias. By inhibiting this protein, it helps control the spread of the disease.

  • Phesgo

    is an injection that combines two antibodies, trastuzumab and pertuzumab. Both target the HER2 protein on some breast cancer cells, helping the immune system destroy them and slowing tumor growth.

What is already known about the treatment

  • Abemaciclib

    This oral tablet is taken by mouth and is approved for use in several types of breast cancer. It works by blocking proteins called CDK4 and CDK6, which help cancer cells grow and divide. It belongs to the class of CDK4/6 inhibitors and is widely used in current medical practice. The drug is studied for its ability to control disease in patients with advanced cancers that have specific molecular changes.

  • Atezolizumab

    Given as an intravenous infusion, this medication is approved for treating certain lung and bladder cancers. It blocks a protein called PD‑L1, helping the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor and is a well‑established therapy in oncology. Researchers are evaluating its effectiveness in advanced cancers with known molecular profiles.

  • Alectinib

    This oral capsule is taken by mouth and is approved for treating ALK‑positive non‑small cell lung cancer. It blocks the activity of the ALK protein, which drives tumor growth when mutated. It belongs to the class of ALK inhibitors and is a standard option for patients with this genetic alteration. The trial examines its disease‑control potential in advanced cancers.

  • Vismodegib

    Administered as an oral capsule, this drug is approved for basal cell skin cancer that cannot be treated with surgery. It blocks the Hedgehog signaling pathway, which many tumors use to grow. It is a Hedgehog pathway inhibitor and is available on the market for specific skin cancers. The study includes it to see if it can help control other advanced cancers with similar pathways.

  • Ponatinib

    This oral tablet is approved for certain blood cancers, such as chronic myeloid leukemia resistant to other treatments. It blocks the BCR‑ABL protein and other related proteins that cause cancer cells to multiply. It is classified as a multi‑kinase inhibitor and is commonly used in clinical practice. The trial tests its ability to control disease in advanced cancers with relevant molecular targets.

  • Trastuzumab/pertuzumab

    This combination is given by injection and is approved for HER2‑positive breast cancer. The two antibodies bind to different parts of the HER2 protein, stopping the signal that tells cancer cells to grow. They belong to the class of monoclonal antibodies targeting HER2 and are standard treatments for HER2‑positive disease. The study evaluates their combined effect on advanced cancers with HER2 alterations.

Investigated diseases

Advanced Cancer - A condition where cancer cells have spread beyond their original location to other parts of the body. It develops when cancer cells break away from the primary tumor and travel through the bloodstream or lymphatic system to form new tumors in other organs or tissues. The process of cancer spreading is called metastasis, and these new tumor sites are called metastases. Advanced cancer typically involves multiple areas of the body and represents a later stage of the disease progression. The behavior of advanced cancer varies depending on the type of original cancer and which organs are affected.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517478-68-01Protocol codeFINPROVEEstimated enrolment250 patientsSponsorHUS-Yhtymae

sourced from the EU Clinical Trials Register and site verification

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