Status:
ACTIVE_NOT_RECRUITING
Durvalumab and Tremelimumab for Pediatric Malignancies
Lead Sponsor:
AstraZeneca
Conditions:
Pediatric Cancer
Solid Tumor Pediatric
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
PHASE2
Brief Summary
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 s...
Detailed Description
This is a first time in pediatrics study primarily designed to evaluate the safety and tolerability of durvalumab and durvalumab in combination with tremelimumab at increasing doses in pediatric patie...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03837899
Start Date
March 7 2019
End Date
December 30 2024
Last Update
October 29 2024
Active Locations (19)
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1
Research Site
Baltimore, Maryland, United States, 21231
2
Research Site
Boston, Massachusetts, United States, 02115
3
Research Site
New Hyde Park, New York, United States, 11040
4
Research Site
Oklahoma City, Oklahoma, United States, 73104