Not recruiting

Study on Niraparib and Dostarlimab for Patients with DNA Repair-Deficient or Platinum-Sensitive Solid Tumors

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 the effects of a combination of two medications, Niraparib and Dostarlimab, on certain types of cancer known as DNA repair-deficient or platinum-sensitive solid tumors. These are cancers that have difficulty repairing their DNA or respond to platinum-based chemotherapy. The purpose of the study is to evaluate how well these medications work together in treating these specific cancers.

The study involves administering Niraparib, which is taken as a tablet by mouth, and Dostarlimab, which is given as an infusion into a vein. Participants will receive these treatments over a period of up to 24 months. Throughout the study, the response of the tumors to the treatment will be monitored to assess the effectiveness and safety of the drug combination.

Participants will be regularly checked to see how their cancer is responding to the treatment and to monitor any side effects. The study aims to provide valuable information on whether this combination of medications can help improve outcomes for patients with these specific types of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and consent
Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes a review of your medical history and a physical examination.
You will be required to sign a written informed consent form, indicating your understanding and agreement to participate in the study.
Step 2
Baseline tests and evaluations
Before starting the treatment, baseline tests will be conducted. These may include blood tests, imaging scans like CT or MRI, and a biopsy if necessary.
These tests help establish a starting point for measuring the effects of the treatment.
Step 3
Treatment initiation
The treatment involves two medications: dostarlimab and niraparib.
Dostarlimab is administered as an intravenous injection. The specific dosage and frequency will be determined by the study protocol.
Niraparib is taken orally in the form of film-coated tablets. The dosage is 100 mg, and the frequency will be specified by the study protocol.
Step 4
Ongoing treatment and monitoring
Throughout the study, you will continue to receive the medications as per the schedule outlined in the study protocol.
Regular monitoring will occur, including follow-up visits, blood tests, and imaging scans to assess the response to treatment and monitor for any side effects.
Step 5
Evaluation of response
At 15 weeks, your response to the treatment will be evaluated using criteria known as RECIST v1.1, which measures changes in tumor size.
Additional evaluations may occur at 21 weeks and at other specified intervals to assess the overall response and progression.
Step 6
End of treatment and follow-up
Upon completion of the treatment phase, a final assessment will be conducted to evaluate the overall outcome.
Follow-up visits may be scheduled to monitor your health and any long-term effects of the treatment.

Who can join the trial?

16 criteria

Must be at least 18 years old.
Must have a confirmed diagnosis of a progressive metastatic or recurrent solid tumor. This means the cancer has spread or returned after treatment.
Must show evidence that the disease is getting worse before joining the trial.
Must have tried standard treatments or not be eligible for them.
Must provide a sample of the tumor for testing. If not enough sample is available, a new biopsy may be needed.
Must have at least one tumor that can be measured using a scan like a CT or MRI. This tumor should not have been treated with radiation before.
Must have a performance status of 0 or 1. This means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have a life expectancy of more than 12 weeks.
Must have adequate blood and organ function based on recent lab tests.
Women who can have children must have a negative pregnancy test before starting the study and agree to use effective birth control methods during the study and for 180 days after.
Women must agree not to breastfeed during the study and for 180 days after the last treatment.
Participants must agree not to donate blood during the study and for 90 days after the last treatment.
Sexually active men must agree to use condoms during the study and for 180 days after the last treatment. It is also recommended that their partners use effective birth control methods.
Must understand and sign a consent form before any study procedures.
Must be willing to attend study visits and follow study procedures.
Must be part of a social security system or have equivalent coverage.

Who cannot join the trial?

12 criteria

Patients who have not recovered from previous treatments or surgeries.
Patients with active infections that require treatment.
Patients with other types of cancer that are not the focus of this study.
Patients who are pregnant or breastfeeding.
Patients with known allergies to the study drugs.
Patients with severe heart conditions.
Patients with uncontrolled high blood pressure.
Patients with a history of certain lung diseases.
Patients with a history of certain liver diseases.
Patients with a history of certain kidney diseases.
Patients who have participated in another clinical trial recently.
Patients who are unable to follow the study procedures.

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Verified sites

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

Centre De Lutte Contre Le Cancer Eugene Marquis
Verified
Rennes, France
Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France
Centre Oscar Lambret
Verified
Lille, France

Trial locations

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Investigated drugs

Niraparib
is a type of medication known as a PARP inhibitor. It works by blocking an enzyme that helps repair damaged DNA in cells. In cancer treatment, this can be beneficial because it prevents cancer cells from repairing themselves, leading to their death. This medication is used in the trial to see if it can help stop the growth of tumors in patients with certain types of cancer that have problems with DNA repair or are sensitive to platinum-based treatments.
Dostarlimab
, also known by its code name TSR-042, is an immunotherapy drug. It works by helping the body's immune system recognize and attack cancer cells. It does this by blocking a specific protein that usually helps cancer cells hide from the immune system. In this trial, Dostarlimab is being tested to see if it can enhance the body's ability to fight cancer in patients with advanced solid tumors that have specific characteristics, such as DNA repair deficiencies or sensitivity to platinum treatments.

What is already known about the treatment

Niraparib
Niraparib is taken orally in the form of a capsule and is currently being studied for its effectiveness in treating certain types of solid tumors that are sensitive to platinum-based treatments or have issues with DNA repair. It is mainly used for its potential to help fight these cancers by interfering with the cancer cells' ability to repair their DNA, which can lead to their death. Niraparib belongs to a class of drugs known as PARP inhibitors, which target specific enzymes involved in DNA repair processes.
Dostarlimab
Dostarlimab is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is being researched for its potential to treat solid tumors that are either sensitive to platinum-based treatments or have problems with DNA repair. This medication works by helping the immune system recognize and attack cancer cells more effectively. Dostarlimab is classified as an immune checkpoint inhibitor, which helps to unleash the body's natural immune response against cancer cells.

Investigated diseases

DNA repair-deficient solid tumors
These tumors occur when cells have a reduced ability to repair DNA damage, leading to genetic mutations that can cause cancer. The progression involves the accumulation of genetic errors, which can result in uncontrolled cell growth and tumor formation. As the tumor grows, it may invade surrounding tissues and potentially spread to other parts of the body. The lack of effective DNA repair mechanisms makes these tumors more sensitive to certain types of chemotherapy. Over time, the tumor may develop resistance to treatment, complicating management. The behavior and growth rate of these tumors can vary depending on the specific genetic mutations involved.
Platinum-sensitive solid tumors
These tumors are characterized by their initial responsiveness to platinum-based chemotherapy drugs, such as cisplatin or carboplatin. The progression of these tumors involves a reduction in size or slowing of growth when treated with platinum compounds. Over time, however, the tumor cells may adapt and develop resistance, leading to a recurrence or continued growth. The sensitivity to platinum drugs is often linked to the tumor's ability to repair DNA damage. As the disease progresses, the effectiveness of platinum-based treatments may diminish. The rate of progression and response to treatment can vary widely among different types of solid tumors.