Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors

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What is this study about?

This clinical trial is focused on studying the effects of two medications, cobolimab and dostarlimab, in children and young adults who have been diagnosed with certain types of tumors. These tumors may have returned after treatment or have not responded to previous treatments. The study aims to understand how safe and tolerable these medications are when used together, as well as to determine the best dose for treatment. The trial will also explore how these medications work in the body and their ability to fight tumors.

The study will be conducted in two parts. In the first part, participants with advanced solid tumors will receive the combination of cobolimab and dostarlimab to assess safety and determine the appropriate dosage. In the second part, the study will focus on specific types of cancer, including melanoma and Hodgkin lymphoma, to evaluate the effectiveness of the treatment. Participants will receive the medications through an intravenous infusion, which means the medicine is given directly into a vein.

Throughout the study, participants will be closely monitored for any side effects and changes in their health. The trial will help researchers gather important information about the potential benefits and risks of using cobolimab and dostarlimab together in treating these challenging conditions. The study is expected to continue until 2030, providing valuable insights into new treatment options for young patients with difficult-to-treat tumors.

1 joining the study

Upon joining the study, the participant will provide written informed consent or assent. This is a formal agreement to participate in the clinical trial after understanding its nature and potential risks.

2 initial assessment

The participant will undergo an initial assessment to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests to ensure adequate organ function and overall health status.

3 treatment administration

The participant will receive two medications: dostarlimab and cobolimab. Both medications are administered as a solution for infusion through an intravenous line. The specific dosage and frequency will be determined by the study protocol and the participant’s specific needs.

4 monitoring and follow-up

Throughout the study, the participant will be closely monitored for any side effects or changes in health status. Regular follow-up visits will include physical exams, laboratory tests, and imaging studies to assess the response to treatment and ensure safety.

5 completion of treatment

Upon completion of the treatment phase, the participant will undergo a final assessment. This will include a comprehensive evaluation of health status and any changes observed during the study.

6 post-study follow-up

After the study ends, the participant may be asked to attend follow-up visits to monitor long-term effects and gather additional data on the treatment’s impact.

Who Can Join the Study?

Participants must be within the following age ranges at the time of signing the consent form:
- Part 1:
  - Cohort 1a: 12 years to less than 18 years
  - Cohort 1b: 6 years to less than 12 years
  - Cohort 1c: 2 to less than 6 years
  - Cohort 1d: 0 to less than 2 years
- Part 2:
  - Cohort A: 6 to less than 21 years
  - Cohort B: 6 to less than 21 years
  - Cohort C: Age to be decided
Participants must have advanced or metastatic solid tumors that have worsened after treatment with available therapies, and have limited treatment options. Prior exposure to immunotherapy or experimental therapies is acceptable.
Participants must have at least one measurable lesion (an area of the tumor that can be measured) as determined by the local site investigator or radiology assessment. If the lesion was previously treated with radiation, it must show disease progression to be considered measurable.
Participants must have a performance status of 60% or higher on the Karnofsky scale (for those older than 16 years) or the Lansky scale (for those 16 years or younger). These scales measure the participant’s ability to perform daily activities.
Participants must have adequate organ function as shown by specific blood test results, including:
- Absolute Neutrophil Count (ANC) of at least 1,000/μL
- Platelets of at least 75,000/μL
- Hemoglobin of at least 9 g/dL or 5.6 mmol/L
- Glomerular Filtration Rate (GFR) of at least 50 mL/min
- AST and ALT (liver enzymes) less than 2.5 times the upper limit of normal
- Bilirubin less than 1.5 times the upper limit of normal
- International Normalized Ratio (INR) or Prothrombin Time (PT) less than 1.5 times the upper limit of normal, unless on anticoagulant therapy
- Activated Partial Thromboplastin Time (aPTT) less than 1.5 times the upper limit of normal, unless on anticoagulant therapy
Adolescent participants who have entered puberty must agree to use contraceptive measures or refrain from sexual intercourse, and avoid sperm or egg donation during the study and for at least 150 days after the last dose of the study intervention. Female participants must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
The participant or their legally acceptable representative, parent(s), or legal guardian must provide written informed consent before any study-specific activities are performed.

Who Cannot Join the Study?

Patients who have not recovered from previous treatments or surgeries.
Patients with other serious illnesses that are not controlled.
Patients who are pregnant or breastfeeding.
Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer.
Patients who have had an organ transplant.
Patients with known allergies to the study drugs.
Patients who are taking other experimental drugs.
Patients with active infections that require treatment.
Patients with certain heart conditions.
Patients with a history of certain lung diseases.
Patients with a history of certain neurological or psychiatric disorders.
Patients who have received a live vaccine within 30 days before the start of the study.
Patients with a history of autoimmune diseases, which are conditions where the immune system attacks the body.
Patients with a history of drug or alcohol abuse.

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
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Azienda Ospedaliera Santobono Pausilipon	Naples	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Fakultni Nemocnice Brno	Brno	Czechia
Robert Debre University Hospital	Paris	France
Rigshospitalet	Copenhagen	Denmark
Centre Hospitalier Lyon Sud	Pierre Benite	France
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Hospital Universitario Hm Monteprincipe	Boadilla Del Monte	Spain
Uruazdebjz Mgoutij Cnxrup Hddhzkinqikjluawt	Hamburg	Germany
Fkgjauaf niesfysps Mgjww a Hwberth	Prague	Czechia
Aiybymmala Ptyfnhfb Hgtobvmy Dt Mwraixune	Marseille	France
Ampwqhu Ooyqppzubae Uukbcqjhnycxm Cfakkdwtasbe Dahvv Sjwvnx E Ddupk Svvvkpn Dr Thppes	Turin	Italy
Ufnisvhbluetxxigsifxq Wpylsikig Azi	Wuerzburg	Germany
Altnzbo Uopfb Smjtbnmgc Lbsuhc Dm Bljzoqr	Bologna	Italy
Fouuvxyic Ptoz Ll Iahpxxwlpwsdb Bbfjvsoox Dxg Hnzedfbj Uuuudjgnmqnos Lf Pup	Madrid	Spain
Hvzjgozh Vgex dlpyoavp	Barcelona	Spain
Hkpzqqcl Ufcmxhjizvikdd Slvnygohpm &bbgvph Hdrypba df Hsvvxqtxowb	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.11.2024
Denmark	Not recruiting	01.11.2024
France	Not recruiting	01.11.2024
Germany	Not recruiting	01.11.2024
Italy	Not recruiting	01.11.2024
Spain	Not recruiting	01.11.2024

Trial locations

Investigated drugs:

Cobolimab is a medication being studied for its potential to help treat advanced solid tumors in children and young adults. It is being tested to see if it can be safely used in combination with another medication, dostarlimab, to help the body’s immune system fight cancer cells more effectively. The study aims to find out how well cobolimab works when used together with dostarlimab and to determine the best dose for patients.

Dostarlimab is another medication involved in this study, which is also being tested for its ability to treat advanced solid tumors in children and young adults. Dostarlimab is designed to help the immune system recognize and attack cancer cells. In this trial, it is used in combination with cobolimab to see if the two medications together can improve treatment outcomes for patients with certain types of cancer, such as melanoma and Hodgkin lymphoma.

Investigated diseases:

Melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. It often develops in areas exposed to the sun, such as the back, legs, arms, and face, but can also occur in areas not typically exposed to sunlight. The disease progresses as the cancerous cells grow uncontrollably and can spread to other parts of the body through the lymphatic system or bloodstream. Early stages may present as a new mole or a change in an existing mole, with irregular borders, multiple colors, or an increase in size. As melanoma advances, it can invade deeper layers of the skin and metastasize to distant organs. The progression of melanoma can vary, with some cases remaining localized for years, while others spread rapidly.

Hodgkin Lymphoma – Hodgkin lymphoma is a type of cancer that originates in the lymphatic system, specifically affecting a type of white blood cell called lymphocytes. It is characterized by the presence of Reed-Sternberg cells, which are large, abnormal lymphocytes. The disease typically begins in the lymph nodes and can spread to other lymph nodes, the spleen, liver, bone marrow, or other organs. As Hodgkin lymphoma progresses, it may cause symptoms such as painless swelling of lymph nodes, fever, night sweats, and weight loss. The progression can vary, with some cases remaining indolent for a long time, while others may advance more quickly. The disease is often categorized into different stages based on the extent of spread within the body.

Trial ID:

2024-511350-41-00

Protocol code:

219451

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Cobolimab and Dostarlimab for Children and Young Adults with Newly Diagnosed or Relapsed/Refractory Tumors

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