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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Rostock University Medical Center	Rostock	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Fakultni Nemocnice Brno	Brno	Czechia
Semmelweis University	Budapest	Hungary
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Uyjoflnbfo Mjsggzz Cpojaa Huleuysubqjwzovjq	Hamburg	Germany
Ucktqqtaebsdjmxxlfpar Eewkk Akl	Essen	Germany
Furvbkfq njrvqdlfy Mdsth a Hropqoc	Prague	Czechia
Azdgeflxzy Pxuzxegb Hsbodulz Dn Mofhdzakh	Marseille	France
Uyyifnfivatkqemnshgfm Dhhvweehtpm Azf	Duesseldorf	Germany
Gezpcz Ucpoqwfpnl Fvrezqlbl	Frankfurt	Germany
Frbxgrmxr Phrs Ln Iryphozbhgzom Bkmntxcss Dgs Hkdklvjp Uwvzpiuxpldvq Le Pra	Madrid	Spain
Hdyvhjqr Vvhl dhrdbamj	Barcelona	Spain
Cvipjd Oemxi Levzeql	Lille	France
Ivchcxdh Cywej	Paris	France

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	12.10.2020
France	Not recruiting	12.10.2020
Germany	Not recruiting	12.10.2020
Hungary	Not recruiting	12.10.2020
Spain	Not recruiting	12.10.2020

Trial locations

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.

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 ID:

2024-511071-16-00

Protocol code:

213406

Trial Phase:

Human Pharmacology (Phase I) – Other

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

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