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

2 1 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Oulu University Hospital Oulu Finland
Pohjois-Savon hyvinvointialue Kuopio Finland
Pirkanmaan hyvinvointialue Tampere Finland
Vskuzbwczfljrbnj haxcowmerulpids Turku Finland
Hbxumhvc Ugjlyduvdi Ctllaww Hdhnmvuf Helsinki Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Recruiting
30.11.2021

Trial locations

Based on the provided data, I cannot identify any specific medications or therapies to list, as the trial information doesn’t contain details about individual treatments. The trial appears to be a Finnish study focused on targeted anti-cancer drugs, but specific medications are not mentioned in the source data. Without concrete information about the medications or therapies used in the trial, I cannot provide detailed descriptions of the treatments involved.

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 ID:
2024-517478-68-01
Protocol code:
FINPROVE
NCT ID:
NCT05159245
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A Phase I/II Study of GVV858 Alone or in Drug Combination for Patients with Advanced Hormone Receptor‑Positive, HER2‑Negative Breast Cancer

    Recruiting

    2 1 1 1
    Czechia Denmark France Germany Italy Spain
  • A study of PM54 and pembrolizumab in adults with advanced cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain