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Durvalumab and Tremelimumab for Pediatric Malignancies

Trial Status: Active

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.

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
  • Malignant neoplasms of hematopoietic and lymphoid tissue and myelodysplastic syndrome: pathologically confirmed relapsed or refractory advanced hematological malignancies including lymphoma and acute leukemia
  • 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 HL, NHL, ALL and AML, 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)

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

Massachusetts

Boston
Boston Children's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

South Carolina

Charleston
Medical University of South Carolina
Status: ACTIVE

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 patients with advanced solid malignancies and hematological malignancies

(including lymphomas) and for whom no standard of care treatments exist. Although treatment

efficacy is not a primary objective of this study given its early phase nature, the patients

screened for this study have no curative options and this study offers the potential of some

benefit.

The study will also characterize the PK of durvalumab and durvalumab in combination with

tremelimumab in children and adolescents and explore potential biological activity and

immunogenicity by assessing pharmacodynamics, anti drug antibody (ADA) levels, and anti-tumor

activity. The results from this trial will form the basis for decisions for potential future

pediatric studies.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D419EC00001
  • Secondary IDs NCI-2019-01529
  • Clinicaltrials.gov ID NCT03837899