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Study of Dabrafenib and Drug Combination for Patients with Metastatic Non-Clear Cell Kidney Cancer

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 is focused on studying an individualized treatment strategy for patients with metastatic non-clear cell kidney cancer. The study involves several medications, including Tafinlar (dabrafenib), Imatinib Accord (imatinib), IBRANCE (palbociclib), XALKORI (crizotinib), YERVOY (ipilimumab), Kadcyla (trastuzumab emtansine), KEYTRUDA (pembrolizumab), Lynparza (olaparib), OPDIVO (nivolumab), Alecensa (alectinib hydrochloride), TAGRISSO (osimertinib), CABOMETYX (cabozantinib), Tarceva (erlotinib), Mekinist (trametinib), and Sutent (sunitinib). Some of these medications are taken orally as capsules or tablets, while others are given through an infusion, which is a method of delivering medication directly into the bloodstream.

The purpose of the study is to analyze how well patients respond to these treatments and how long they can continue the treatment without it failing. The study will follow participants over a period of time to observe their response to the treatment. Participants will receive either the study medication or a placebo, and their health will be monitored regularly to assess the effectiveness and safety of the treatment. The study aims to gather information on the overall response rate, which includes both complete and partial responses to the treatment, as well as the time it takes for the treatment to no longer be effective.

Throughout the study, participants will undergo various assessments to monitor their health and the progression of their cancer. These assessments may include imaging tests and laboratory tests to evaluate the impact of the treatment on the cancer and the patient's overall health. The study will also collect information on the duration of response to the treatment, the rate of disease control, and any side effects experienced by the participants. This information will help researchers understand the potential benefits and risks of the treatment strategy for patients with metastatic non-clear cell kidney cancer.

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
Joining the study
Upon joining the study, the patient will begin the trial with a signed informed consent form. This document confirms understanding and agreement to participate in the study.
The patient must be at least 18 years old and have a confirmed diagnosis of metastatic non-clear cell renal cell carcinoma, which is a type of kidney cancer that has spread to other parts of the body.
Step 2
Initial assessments
Initial assessments will include a biopsy to confirm the diagnosis and collect tissue for DNA and RNA analyses. This is important for tailoring the treatment strategy.
The patient will undergo various laboratory tests to ensure eligibility, including blood tests to check leukocytes, thrombocytes, and haemoglobin levels, as well as liver and kidney function tests.
Step 3
Treatment phase
The treatment phase involves administering medications based on the individualized treatment strategy. The medications include dabrafenib, imatinib, palbociclib, crizotinib, ipilimumab, trastuzumab emtansine, pembrolizumab, olaparib, nivolumab, alectinib hydrochloride, osimertinib, cabozantinib, erlotinib, trametinib, and sunitinib.
Medications are administered either orally or through intravenous infusion, depending on the specific drug. The frequency and dosage will be determined by the healthcare provider based on the patient's condition and response to treatment.
Step 4
Monitoring and follow-up
Throughout the trial, the patient's response to treatment will be closely monitored using imaging tests and other assessments to evaluate the overall response rate and time to treatment failure.
Regular follow-up visits will be scheduled to assess the patient's health status, manage any side effects, and adjust the treatment plan as necessary.
Step 5
Completion of the trial
The trial is expected to conclude by September 2025. At the end of the trial, the patient's overall health and response to the treatment will be evaluated.
The results will contribute to understanding the effectiveness of the individualized treatment strategy for metastatic non-clear cell renal cell carcinoma.

Who can join the trial?

20 criteria

The patient must sign a form to show they understand and agree to participate in the study.
The patient must be willing and able to follow the study's rules and procedures.
The patient must be 18 years old or older.
The patient must have a confirmed diagnosis of a type of kidney cancer that cannot be removed by surgery, or a specific type of kidney tumor called sarcomatoid tumor.
If the cancer was diagnosed more than a year ago, a new biopsy (a small tissue sample) may be needed to confirm the diagnosis and for further analysis.
If the patient had surgery to remove the kidney less than a year ago and no tissue samples are stored, a new biopsy may be needed for analysis.
If the cancer spread to other parts of the body and was confirmed by biopsy more than a year ago without starting treatment, a new biopsy is offered but not required.
If the patient had surgery with tissue stored and has been diagnosed with cancer spread within a year, a new biopsy from the spread area is offered if easily accessible, but not required.
A biopsy is mainly taken from the spread area, but can also be from the kidney tumor.
A biopsy cannot be taken from bones as it cannot be used for analysis.
If the main tumor is a clear cell type but the spread area shows a different type, the patient can still join the study.
There must be enough tissue for DNA and RNA analysis, which are tests to study the genetic material of the cancer.
Females must have a negative pregnancy test or be unable to have children (due to menopause or surgery) and must not be breastfeeding.
Females who can have children and males must use effective birth control methods.
The patient must have measurable disease, meaning the cancer can be measured using specific criteria.
The patient must have a certain level of physical ability, measured by a performance status score.
The patient must have a life expectancy of more than 3 months.
The patient must have certain blood test results within specific ranges, including white blood cells, platelets, and hemoglobin levels.
The patient must have certain biochemistry test results within specific ranges, including bilirubin, INR, APTT, and liver enzymes.
The patient must have a kidney function test result (eGFR) greater than 30.

Who cannot join the trial?

6 criteria

Patients with other types of cancer that are not **metastatic non-clear cell renal cell carcinoma** cannot participate. **Metastatic** means the cancer has spread to other parts of the body.
Patients who have had another cancer treatment recently may not be eligible.
Patients with serious health conditions that could interfere with the study may be excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures or attend study visits may not be eligible.
Patients who have participated in another clinical trial recently may be excluded.

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Verified sites

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Herlev Hospital
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Herlev, Denmark

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Investigated drugs

Sunitinib
is a medication used in this trial to treat patients with metastatic non-clear cell renal carcinoma. It works by blocking certain proteins that promote the growth of cancer cells, helping to slow down or stop the progression of the disease.
Everolimus
is another medication involved in the trial. It helps to treat cancer by interfering with the growth of cancer cells and slowing their spread in the body. It is often used when other treatments have not been effective.
Cabozantinib
is used in this trial to target and inhibit the activity of certain proteins that are involved in the growth and spread of cancer cells. This medication aims to reduce the size of tumors and limit the progression of the cancer.
Nivolumab
is an immunotherapy drug included in the trial. It works by helping the immune system recognize and attack cancer cells more effectively. This can lead to a reduction in tumor size and slow the progression of the disease.

What is already known about the treatment

Sunitinib – Sunitinib is administered orally in the form of capsules. It is currently used in the treatment of certain types of cancer, including metastatic non-clear cell renal cell carcinoma, and is well-documented in medical literature. The main therapeutic indication for Sunitinib is to treat advanced kidney cancer. At the molecular level, it works by inhibiting multiple receptor tyrosine kinases, which are involved in the growth and spread of cancer cells. Sunitinib is classified as a tyrosine kinase inhibitor in pharmacology.

Investigated diseases

Metastatic non-clear cell renal cell carcinoma – This is a type of kidney cancer that originates in the renal cells and is characterized by the absence of clear cells, which are typically found in the more common clear cell renal cell carcinoma. The disease is considered metastatic when it spreads beyond the kidney to other parts of the body. It progresses as cancerous cells grow and invade surrounding tissues, potentially affecting organs such as the lungs, bones, or liver. The progression can vary, with some patients experiencing rapid growth and others having a slower course. Symptoms may include blood in the urine, pain in the side or back, and unexplained weight loss. The disease's behavior and progression can differ significantly from the clear cell variant, often requiring distinct management approaches.