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Study of Drug Combination Treatment Based on Tumor Molecular Changes in Patients with Advanced or Metastatic Cancer

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What is this trial about?

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

This study focuses on patients with advanced cancer or metastatic tumors that have specific molecular changes. The study will test several anti-cancer medications including ribociclib, siremadlin (HDM201), trametinib, dabrafenib, alectinib, regorafenib, cabozantinib, and avapritinib. These medications are designed to target specific changes found in cancer cells.

The purpose of this research is to evaluate how well these medications work when matched to specific molecular changes in a patient's tumor. Each medication will be used to treat cancers that have particular genetic alterations that the drug is designed to target. For example, some patients will receive treatment with trametinib and dabrafenib if their tumor has a specific type of BRAF mutation.

During the study, participants will receive their assigned medication and will be monitored for how their cancer responds to treatment. The medications are taken by mouth daily, and patients will be followed for up to 60 months to assess how well the treatment works. The study will measure if the cancer stops growing or shrinks, and how long any benefits from the treatment last.

The research process

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

Step 1
Initial assessment
A molecular examination of your tumor will determine if you qualify for one of the specific treatment groups.
Your doctor will perform tests to verify your overall health status and measure your ECOG performance score (a measure of your daily activity level).
Laboratory tests will check your organ function within 7 days before starting treatment.
Step 2
Treatment assignment
Based on your tumor's molecular profile, you will be assigned to one of these treatment groups:
- Cabozantinib tablets for specific gene changes in AXL, MET, VEGFR and other genes
- Alectinib capsules for ALK gene changes
- Regorafenib tablets for changes in VEGFR, TIE-2, KIT and other specific genes
- Trametinib with Dabrafenib tablets for BRAF V600 gene change
- Avapritinib tablets for specific KIT or PDGFRA gene changes
Step 3
Treatment period
You will take your assigned medication(s) by mouth daily
Your treatment will continue as long as it remains beneficial
Regular assessments will track your tumor's response to treatment
The main evaluation point will occur after 3 months (12 weeks) of treatment
Step 4
Monitoring
Your tumor will be measured regularly using imaging scans
Blood tests will monitor your organ function
Side effects will be assessed using a standardized scale (CTCAE v5.0)
Treatment will continue until your disease progresses or you experience unacceptable side effects
Step 5
Follow-up period
After treatment ends, your health status will continue to be monitored
Long-term response will be evaluated, particularly if you respond for more than 6 months
Overall survival and progression-free survival data will be collected

Who can join the trial?

12 criteria

Must be at least 18 years old when signing the consent form
Must have advanced or metastatic cancer (cancer that has spread or cannot be surgically removed) that either: - Has not responded to standard treatments - Has no standard treatment options available - Is not suitable for standard treatments according to the doctor
Must have had at least one previous treatment for advanced/metastatic cancer
Must have cancer that can be measured on scans according to RECIST criteria (a standardized way to measure tumors)
Must have good physical functioning ability (ECOG score of 0 or 1, meaning able to perform daily activities)
Must have adequate organ function based on laboratory tests
Must have specific genetic changes in their tumor that match one of the study treatment groups
Any side effects from previous cancer treatments must be resolved or mild (except for hair loss, mild nerve problems, or anemia)
Must be willing and able to follow study procedures and sign informed consent
Must have medical insurance
Women who can become pregnant must have a negative pregnancy test within 7 days before starting treatment
Both men and women must use effective birth control during the study (duration depends on treatment group)

Who cannot join the trial?

13 criteria

Age below 18 years old
Pregnancy or breastfeeding
Active brain metastases (cancer that has spread to the brain) that are not treated or stable
History of severe allergic reactions to study medications
Serious heart conditions, including heart failure (when heart cannot pump blood effectively), unstable angina (chest pain), or recent heart attack
Severe liver problems with liver function tests more than 3 times the normal limit
Severe kidney problems with creatinine clearance (a measure of kidney function) less than 30 mL/min
Active, uncontrolled infections
Other cancers diagnosed within the past 3 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
Participation in another clinical trial within 30 days before starting this study
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to swallow oral medications
Mental conditions that would interfere with following study procedures

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Centre Francois Baclesse
Caen, France
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Centre Henri Becquerel
Rouen, France
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Centre Leon Berard
Lyon, France

Trial locations

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Investigated drugs

Based on the provided data, I cannot generate a list of medications as the trial information does not contain specific details about the medications or therapies involved. The trial appears to be a Phase II study evaluating anti-cancer treatments, but the specific medications are not listed in the source data. The study is described as "biology driven" and aims to evaluate treatments targeting molecular alterations in tumors, but without the actual medication names being provided, I cannot create accurate medication descriptions.

What is already known about the treatment

Based on the provided data, there are no specific medications listed in the trial information. This appears to be a Phase II study focusing on evaluating various anti-cancer treatments based on tumor molecular characteristics, but the specific medications are not detailed in the source data. Without specific medication names, I cannot provide the requested medication descriptions in the specified format. If you could provide the actual medications being tested in this trial, I would be happy to describe them according to the format you've outlined.

Investigated diseases

Advanced Cancer
A condition where cancer cells have spread beyond their original location to other parts of the body through the bloodstream or lymphatic system. In this stage, cancer cells form new tumors in different organs or tissues, known as metastases. The disease typically develops gradually, with cancer cells first growing locally, then breaking away from the original tumor and traveling through the body. These cells can establish themselves in new locations, forming secondary tumors that may affect the function of involved organs.
Metastatic Cancer
A phase of cancer where malignant cells have spread from their primary site to other locations in the body. The process begins when cancer cells break away from the original tumor and travel through blood vessels or lymph nodes to reach distant organs. These cells then establish themselves in new locations, where they multiply and form additional tumors. The disease can affect multiple body systems simultaneously, depending on where the cancer spreads.