Durvalumab and Tremelimumab for Pediatric Malignancies
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
50actual
Sites
19
Countries
France, Germany, Italy +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-03-07 | actual | When the study began enrolling |
| Primary completion | 2023-02-28 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2019-02-12 | actual | When this record first appeared on the registry |
| Results posted | 2024-03-19 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Pediatric Cancer
- Solid Tumor Pediatric
- Hematological Malignancies
Intervention
- Drug: Durvalumab / Tremelimumab Combination Therapy — also filed as durvalumab: Imfinzi, MEDI4736, tremelimumab: CP-675,206
Primary outcomes
what the primary-completion date above is the date OFDose-Finding Phase: Maximum Serum Concentration (Cmax) of Durvalumab
measured 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
measured 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: Area Under the Serum Concentration-Time Curve (AUC) From Zero to 14 (AUC 0-14) of Durvalumab
measured 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
measured 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
measured 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: Apparent Terminal Elimination Half-life Associated With the Terminal Slope of the Semi-logarithmic Concentration Time Curve (t½λz) of Durvalumab
measured 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: Dose-Normalized AUC (0-14) (AUC [0-14]/D) of Durvalumab
measured Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8
Dose-Finding Phase: Dose-Normalized AUC (0-28) (AUC [0-28]/D) of Durvalumab
measured Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15
Dose-Finding Phase: Dose-Normalized Cmax (Cmax/D) of Durvalumab
measured 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: Cmax of Tremelimumab
measured Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5
Dose-Finding Phase: Cmin of Tremelimumab
measured Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5
Dose-Finding Phase: (AUC 0-14) of Tremelimumab
measured Pre-infusion and post-infusion on Cycle 2 Day 1, and Cycle 2 Day 8
Dose-Finding Phase: (AUC 0-28) of Tremelimumab
measured Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, and Cycle 2 Day 15
Dose-Finding Phase: Tmax of Tremelimumab
measured Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5
Dose-Finding Phase: T½λz of Tremelimumab
measured Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5
Dose-Finding Phase: AUC (0-14)/D of Tremelimumab
measured Pre-infusion and post-infusion on Cycle 2 Day 1 and Cycle 2 Day 8
Dose-Finding Phase: AUC (0-28)/D of Tremelimumab
measured Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, and Cycle 2 Day 15
Dose-Finding Phase: Cmax/D of Tremelimumab
measured Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5
Dose-Finding Phase: Number of Participants With Adverse Events (AE), Serious AE (SAE), AE Leading to Discontinuation of Durvalumab and Tremelimumab, AE of Special Interest (AESI) or AE of Possible Interest (AEPI) Related to Durvalumab and Tremelimumab
measured From Day 1 up to 15 months
Dose-Expansion Phase Only: Objective Response Rate (ORR)
measured From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)
Dose-Expansion Phase Only: Duration of Response (DOR)
measured From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)
Dose-Expansion Phase Only: Best Objective Response (BOR)
measured From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)
Dose-Expansion Phase Only: Disease Control Rate (DCR)
measured At 16 and 24 Weeks
Dose-Expansion Phase Only: PFS
measured From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)
Dose-Expansion Phase Only: Overall Survival (OS)
measured From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)
Dose-Expansion Phase Only: Survival Rate at 12 Months and 24 Months
measured At 12 and 24 Weeks
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2022-12-12 · 6.1 MB · Prot_000.pdf
Statistical Analysis Planposted 2023-04-19 · 1.0 MB · SAP_001.pdf
Publications
- PMID 42222420 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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