Durvalumab and Tremelimumab for Pediatric Malignancies
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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)
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Pediatric Cancer,Solid Tumor Pediatric,Hematological Malignancies
Age (in years)
< 18
Phase
Phase 1/Phase 2
Participants needed
50
Est. Completion Date
Dec 29, 2023
Treatment type
Interventional
Sponsor
AstraZeneca
ClinicalTrials.gov identifier
NCT03837899
Study number
D419EC00001
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