Study of Relatlimab and Nivolumab for Children and Young Adults with Recurrent or Refractory Hodgkin and Non-Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying two types of blood cancers: Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma. These are conditions where the body’s lymphatic system, which is part of the immune system, develops cancerous cells. The study is testing a combination of two medications, Relatlimab and Nivolumab, to see how safe and effective they are for treating these cancers in children and young adults. Relatlimab is given as an injection, while Nivolumab is provided as an infusion, both administered directly into the bloodstream.

The purpose of the study is to understand how well these medications work together and how the body handles them. Participants will receive the treatment and be monitored for any side effects and how their cancer responds. The study is divided into two parts: the first part focuses on children under 18 years old to determine the safest dose, and the second part includes young adults up to 30 years old to assess how well the treatment works based on the findings from the first part.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the progress of their treatment. The goal is to find a new, effective treatment option for those whose cancer has returned or not responded to standard therapies. This study is an important step in exploring new ways to help young patients with these challenging conditions.

1 initial assessment

Upon joining the study, participants will undergo an initial assessment to confirm eligibility. This includes reviewing medical history and current health status.

Participants must have recurrent or refractory classical Hodgkin lymphoma or non-Hodgkin lymphoma and meet specific criteria related to previous treatments and disease state.

2 treatment administration

Participants will receive two medications: relatlimab and nivolumab. Both are administered through an intravenous infusion, which means they are given directly into a vein.

The dosage and frequency of administration will be determined based on the study’s phase and the participant’s specific needs. The treatment aims to evaluate safety and effectiveness.

3 monitoring and follow-up

Participants will be closely monitored for any side effects or adverse reactions. Regular check-ups and tests will be conducted to assess the body’s response to the treatment.

The study will track various health indicators, including the maximum concentration of the medication in the blood and the overall response rate to the treatment.

4 completion and evaluation

At the end of the treatment period, participants will undergo a final evaluation to determine the treatment’s effectiveness and any long-term effects.

The study aims to gather comprehensive data on the safety and potential benefits of the medication combination for future treatment considerations.

Who Can Join the Study?

Participants must be male or female.
Participants must be less than 18 years old for Part A of the study, and 30 years old or younger for Part B.
Participants must have Recurrent or Refractory Classical Hodgkin Lymphoma (R/R cHL) or Non-Hodgkin Lymphoma (NHL). “Recurrent” means the disease has come back after treatment, and “Refractory” means the disease did not respond to treatment.
Participants must have a confirmed diagnosis of high-risk R/R cHL or R/R NHL after not responding to or failing one or more standard treatments.
Participants with R/R NHL may include those with specific types of lymphoma such as:
- Primary mediastinal B-cell lymphoma
- Diffuse large B-cell lymphoma (DLBCL)
- Mediastinal gray zone lymphoma (MGZL)
- Anaplastic large cell lymphoma (ALCL)
- Burkitt lymphoma (with less than 25% malignant cells)
- Lymphoblastic lymphoma (with less than 25% of marrow cells being cancerous)
- NK/T-cell lymphoma (excluding aggressive subtypes)
- Peripheral T-cell lymphoma (PTCL)
The participant’s current disease must be resistant to standard therapy.
Participants must have measurable disease that is PET positive. This means the disease can be seen on a PET scan, a type of imaging test.

Who Cannot Join the Study?

Patients who have a different type of cancer than the ones being studied cannot participate.
Patients who have had a severe allergic reaction to similar medications in the past are not eligible.
Patients who are currently taking other medications that might interfere with the study treatment cannot join.
Patients with uncontrolled infections or other serious illnesses are not allowed to participate.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have received certain treatments recently, such as chemotherapy or radiation, may not be eligible.
Patients with certain heart conditions or other significant health issues might be excluded.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
Assistance Publique Hopitaux De Paris	Paris	France
Dipartimento Di Salute Della Donna E Del Bambino	Padua	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Assistance Publique Hopitaux De Paris	Paris	France
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Azienda Ospedaliera Universitaria Meyer IRCCS	Florence	Italy
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Anuphao Ostcfivgmyy Undgrdfitdfuz Cxkgcmswqmum Dsoge Ssfdig E Diuac Sdlsplm Dh Tezvkt	Turin	Italy
Agdgqek Urwqq Sjasrggoc Lmiauu Dt Biqngwm	Bologna	Italy
Ctrewe Lmrp Btdgrl	Lyon	France
Cevbhu Hjcpmhimxps Rfgdbscu Dhqiihpdzulfbm	Angers	France
Fuqcgccqy Ppny Lt Ihbyufznqvirf Bmimqzktw Dtd Hxcfxejq Uechcezrvnfyw Lv Pzt	Madrid	Spain
Hgyzbcep Vhbq dlenqnpk	Barcelona	Spain
Haieexel Utpfpnxgazvcao Saybebtwpm &odoayo Hgqqskl dj Hdtyqqyanwt	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	28.07.2023
Italy	Not recruiting	28.07.2023
Spain	Not recruiting	28.07.2023
The Netherlands	Not recruiting	28.07.2023

Trial locations

Investigated drugs:

Relatlimab is a type of medication known as an immune checkpoint inhibitor. It works by helping the body’s immune system recognize and attack cancer cells more effectively. In this trial, it is being tested in combination with another medication to see if it can help treat certain types of lymphoma, which are cancers of the lymphatic system.

Nivolumab is another immune checkpoint inhibitor. It helps the immune system fight cancer by blocking a protein that prevents immune cells from attacking cancer cells. In this study, it is used together with Relatlimab to see if the combination can improve treatment outcomes for young patients with specific types of lymphoma.

Classical Hodgkin Lymphoma – Classical Hodgkin Lymphoma is a type of cancer that originates in the lymphatic system, which is part of the immune system. It is characterized by the presence of Reed-Sternberg cells, a specific type of abnormal cell. The disease often begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms may include painless swelling of lymph nodes, fever, night sweats, and weight loss. As the disease progresses, it can affect the body’s ability to fight infections. The progression can vary, with some cases remaining localized while others spread more extensively.

Non-Hodgkin Lymphoma – Non-Hodgkin Lymphoma is a diverse group of blood cancers that develop in the lymphatic system. Unlike Hodgkin Lymphoma, it does not involve Reed-Sternberg cells. The disease can start in various types of white blood cells and can occur in lymph nodes or other lymphatic tissues. Symptoms may include swollen lymph nodes, fever, night sweats, and unexplained weight loss. The progression of Non-Hodgkin Lymphoma can vary widely, with some forms being slow-growing and others being more aggressive. It can spread to other parts of the body, including the liver, bone marrow, and spleen.

Trial ID:

2023-503715-14-00

Protocol code:

CA224-069

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Relatlimab and Nivolumab for Children and Young Adults with Recurrent or Refractory Hodgkin and Non-Hodgkin Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?