Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Niraparib and Dostarlimab for Children with Recurrent or Hard-to-Treat Solid Tumors

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying treatments for children and adolescents with solid tumors, which are abnormal masses of tissue that can occur in various parts of the body. The study involves two medications: niraparib and dostarlimab. Niraparib is taken orally in the form of tablets, while dostarlimab is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to find the best dose of these medications when used together in young patients. The study is divided into different parts. Initially, participants will receive increasing doses of the medications to determine the safest and most effective dose. After establishing the right dose, more participants will receive this dose to further understand how well the treatment works and how the body responds to it.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to observe any effects of the treatment. The study aims to provide valuable information that could help improve treatment options for children and adolescents with solid tumors in the future.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, disease type, and overall health status.

    Participants must have a measurable disease and meet specific health criteria, such as adequate organ function and performance status.

  2. Step 2

    Treatment phase 1a

    Participants receive niraparib in the form of Zejula 100 mg film-coated tablets taken orally. The dosage is adjusted based on individual tolerance and response.

    In addition, dostarlimab is administered as a 500 mg concentrate for solution for infusion through intravenous use. The frequency and duration are determined by the study protocol.

  3. Step 3

    Treatment phase 1b

    Participants receive niraparib in the form of tablets for oral suspension. This phase aims to establish the recommended dose for this formulation.

    The administration of dostarlimab continues as in phase 1a, with adjustments made as necessary based on the participant's response.

  4. Step 4

    Monitoring and evaluation

    Throughout the trial, regular monitoring is conducted to assess the participant's response to treatment and any side effects.

    The primary goal is to determine the optimal dose of the drug combination and evaluate its safety and effectiveness.

  5. Step 5

    Completion and follow-up

    Upon completion of the treatment phases, participants undergo a final evaluation to assess the overall impact of the treatment.

    Long-term follow-up may be required to monitor health outcomes and any delayed effects of the treatment.

Who can join the trial?

12 criteria

  • The participant must be a child or adolescent who is at least 6 months old but younger than 18 years at the time of giving consent. If enrolled under a specific protocol amendment, the age range is 6 months to less than 8 years.
  • The participant must have a type of cancer called a solid tumor. If the participant has a disease other than neuroblastoma, it must be measurable by a method called RECIST v1.1. For neuroblastoma, the disease must be measurable or evaluable by specific criteria. Participants with neuroblastoma that has spread to the bones and is detectable by certain scans are eligible.
  • For a specific part of the study, the participant must be able to swallow a certain medication and have a body weight of at least 20 kg. If they cannot swallow the medication or weigh less than 20 kg, they can still participate but will receive the medication in a different form. In later protocol amendments, the ability to swallow the medication is not a requirement.
  • The participant must have a performance status of at least 60% on a scale that measures their ability to perform daily activities. This is measured differently for those older and younger than 16 years. Participants with stable brain-related issues for at least 7 days before joining the study are eligible. Those who cannot walk due to paralysis but can sit in a wheelchair are considered able to move for this assessment.
  • The participant must have adequate organ function, which includes:
    • A certain level of white blood cells called neutrophils.
    • A certain number of platelets, which help with blood clotting.
    • A certain level of hemoglobin, which carries oxygen in the blood.
    • Normal levels of creatinine, a waste product in the blood, or a certain level of kidney function.
    • Normal levels of bilirubin, a substance made during the breakdown of red blood cells.
    • Normal levels of liver enzymes called AST and ALT, unless there is cancer in the liver, in which case higher levels are allowed.
    • Normal blood clotting times, unless the participant is on blood-thinning medication, in which case the levels should be within the intended range for the medication.
    • A female participant must not be pregnant or breastfeeding and must meet at least one condition specified in the study protocol.

Who cannot join the trial?

8 criteria

  • Participants with certain types of cancer called solid tumors are not eligible.
  • Participants who are not within the specified age range for the study cannot join.
  • Participants who are not able to take the study medications as required will be excluded.
  • Participants with other medical conditions that might interfere with the study treatment will not be allowed.
  • Participants who are pregnant or breastfeeding cannot participate.
  • Participants who have taken certain medications or treatments recently may not be eligible.
  • Participants with a history of allergic reactions to the study drugs will be excluded.
  • Participants who are unable to follow the study procedures or attend required visits will not be included.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Niraparib

    is a medication used in this trial to treat pediatric patients with recurrent or refractory solid tumors. It works by inhibiting certain enzymes that help repair damaged DNA in cancer cells, which can lead to the death of these cells. This medication is being tested in combination with another drug to determine the best dose for children.

  • Dostarlimab

    is another medication involved in this trial. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. By blocking a specific protein that prevents the immune system from attacking cancer cells, dostarlimab can enhance the body's natural defenses against tumors. This medication is being used in combination with niraparib to evaluate its effectiveness in treating pediatric patients with solid tumors.

What is already known about the treatment

  • Niraparib

    Niraparib is administered orally, either as a tablet or as a tablet for oral suspension. It is currently being studied in clinical trials for its effectiveness in treating recurrent or refractory solid tumors in pediatric patients. The medication is primarily used for its potential in cancer treatment, specifically targeting solid tumors. Niraparib works by inhibiting the enzyme poly (ADP-ribose) polymerase (PARP), which helps repair DNA damage in cells. By blocking this enzyme, niraparib prevents cancer cells from repairing themselves, leading to their death. It is classified as a PARP inhibitor in pharmacology.

  • Dostarlimab

    Dostarlimab is administered intravenously and is under investigation in clinical trials for its use in treating recurrent or refractory solid tumors in pediatric patients. It is mainly indicated for its potential in cancer therapy, particularly for solid tumors. Dostarlimab functions by blocking the programmed death receptor-1 (PD-1) pathway, which cancer cells exploit to evade the immune system. By inhibiting this pathway, dostarlimab enhances the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor in pharmacological terms.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. These tumors can be benign, meaning they do not spread to other parts of the body, or malignant, which means they have the potential to invade nearby tissues and spread to other areas. The progression of solid tumors depends on their type and location, as well as the rate at which they grow and spread. Some solid tumors may remain localized, while others can metastasize, affecting other organs and systems. The growth and behavior of solid tumors are influenced by genetic and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase ITrial ID2024-511071-16-00Protocol code213406Estimated enrolment158 patientsSponsorGlaxosmithkline Research & Development Limited

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.