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Durvalumab and Tremelimumab for Pediatric Malignancies

Active Not RecruitingPhase 1, Phase 2

Sponsor: AstraZeneca

Conditions: Pediatric Cancer, Solid Tumor Pediatric, Hematological Malignancies

Interventions: Durvalumab / Tremelimumab Combination Therapy

Countries: United States, France, Germany, Italy, Netherlands, Spain, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 0 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Locations (19)

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