Durvalumab and Tremelimumab for Pediatric Malignancies

  • STATUS
    Recruiting
  • End date
    Dec 22, 2023
  • participants needed
    158
  • sponsor
    AstraZeneca
Updated on 28 November 2021
cancer
lymphoma
acute leukemia
leukemia
durvalumab

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 second phase to test the efficacy of these drugs once this dose is determined

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 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.

Details
Condition Hematologic Malignancy, Blood disorder, Pediatric Cancer, Childhood Cancer, Solid Tumor Pediatric, Blood Cancer, Hematologic Cancer, Hematological Disorders, Hematologic Neoplasms, hematological malignancy, hematologic malignancies, hematological tumor, haematological malignancy, hematological malignancies
Treatment Durvalumab / Tremelimumab Combination Therapy
Clinical Study IdentifierNCT03837899
SponsorAstraZeneca
Last Modified on28 November 2021

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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