Study on Cobolimab and Dostarlimab for Children and Young Adults with Cancer

Sponsor: GlaxoSmithKline

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06521567

Provider View

This clinical trial is testing the safety and best dose of two drugs, cobolimab and dostarlimab, in children and young adults with advanced solid tumors. The study also aims to understand how to manage any side effects and the effects of the treatment on participants.

Patient Parameters

Program Overview

The purpose of this study is to find out the most suitable dose of cobolimab and dostarlimab that children and young adults with advanced solid tumors can tolerate. The study will also check if this combination is safe, how to handle any side effects, and the overall impact of the treatment on the participants.

Eligibility Criteria

Inclusion Criteria

  • Participants aged 0 to 21 years.
  • Have advanced or metastatic solid tumors that have worsened after standard treatments and have limited treatment options.
  • Types of cancer include melanoma, Hodgkin lymphoma, gliomas, osteosarcoma, liver tumors, and rhabdomyosarcoma.
  • For melanoma, participants must not have had prior systemic therapy and may have specific genetic mutations or controlled brain lesions.
  • For Hodgkin lymphoma, participants must have tried at least two previous treatments.
  • Must have a performance status of 60% or higher on specific health scales.
  • Must have adequate organ function as shown by blood tests.
  • Adolescents who have started puberty must agree to use contraception or abstain from sex during treatment.

Exclusion Criteria

  • Uncontrolled brain involvement by cancer.
  • Heart rhythm issues or significant heart disease.
  • Chronic lung disease.
  • Allergies to study drugs or components.
  • History of immune system diseases or organ transplants.
  • Recent plasma exchange or certain lung conditions.
  • Autoimmune diseases needing treatment in the past two years.
  • Unresolved side effects from previous treatments.
  • Serious kidney issues or other unstable medical conditions.
  • Recent use of other cancer treatments or investigational drugs.
  • Recent major surgery or bone marrow transplant.
  • Severe reactions to previous antibody treatments.
  • Positive tests for hepatitis B, hepatitis C, or HIV.
  • Pregnant or breastfeeding women.

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