Durvalumab and Tremelimumab for Pediatric Malignancies

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Pediatric Cancer, Solid Tumor Pediatric, Hematological Malignancies

In brief

The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the efficacy of these drugs once this dose is determined.

Key facts

Study ID

NCT03837899

Run by

AstraZeneca

People needed

50

Starts

2019-03-07

Expected to finish

2026-12-31

Last updated by the study team

2026-07-07

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Max Age =17 years
• Solid Tumors (except primary central nervous system malignant tumors): Patients must have a histopathologic confirmation of malignancy. Patients must have progressed or are refractory to standard therapies, and for whom no standard of care treatments exist
• Non-Hodgkin's Lymphoma, limited to primary mediastinal B-cell lymphoma and anaplastic large cell lymphoma. Patients must have progressed or are refractory to standard therapies, and for whom no standard of care treatments exist.
• Provision of diagnostic tumor sample mandated if available
• Evaluable disease
• No prior exposure to immune-mediated therapy
• Adequate organ and marrow function
• Life expectancy of at least 3 months

You may not qualify if…

• History of allogeneic organ transplantation (exceptions may be allowed for NHL after discussion with Sponsor). History of autologous bone marrow transplant may be allowed (after discussion with Sponsor).
• Active or prior documented autoimmune or inflammatory disorders (exceptions)
• Uncontrolled intercurrent illness
• History of primary immunodeficiency
• Active infection including tuberculosis, hepatitis B, C or HIV
• Any unresolved toxicity NCI CTCAE version 5.0 Grade ≥2 from previous anticancer therapy (exceptions)

Where it is running

• Research Site — Baltimore, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — New Hyde Park, New York, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — Lille, France
• Research Site — Marseille, France
• Research Site — Paris, France
• Research Site — Cologne, Germany
• Research Site — Genova, Italy
• Research Site — Milan, Italy
• Research Site — Rome, Italy
• Research Site — Torino, Italy
• Research Site — Utrecht, Netherlands
• Research Site — Barcelona, Spain
• Research Site — Madrid, Spain
• Research Site — Leeds, United Kingdom
• Research Site — London, United Kingdom
• Research Site — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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