Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or Durvalumab in Combination with Tremelimumab in Pediatric Patients with Advanced Solid Tumors and Hematological Malignancies
Trial Description
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 Requirements
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)