Active — Not RecruitingPhase 1/2

Durvalumab and Tremelimumab for Pediatric Malignancies

United States50 participantsStarted 2019-03-07

Plain-language 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.

Who can participate

Age range0 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Dose-Finding Phase: Maximum Serum Concentration (Cmax) of Durvalumab

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 6, 8, 10 and 12

Dose-Finding Phase: Minimum Serum Concentration (Cmin) of Durvalumab

Dose-Finding Phase: Area Under the Serum Concentration-Time Curve (AUC) From Zero to 14 (AUC 0-14) of Durvalumab

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8

Dose-Finding Phase: AUC From Zero to 28 (AUC 0-28) of Durvalumab

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15

Dose-Finding Phase: Time to Cmax (Tmax) of Durvalumab

Dose-Finding Phase: Apparent Terminal Elimination Half-life Associated With the Terminal Slope of the Semi-logarithmic Concentration Time Curve (t½λz) of Durvalumab

Trial details

NCT IDNCT03837899

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-28

Results submitted2023-11-16

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