TriangleNCT03837899 · CITED IN SOURCE DOCUMENTS
Durvalumab and Tremelimumab for Pediatric Malignancies
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1, PHASE2
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-07-07
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Dose-Finding Phase: Maximum Serum Concentration (Cmax) of Durvalumab
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
Dose-Finding Phase: AUC From Zero to 28 (AUC 0-28) of Durvalumab
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
Dose-Finding Phase: Dose-Normalized AUC (0-14) (AUC [0-14]/D) of Durvalumab
Dose-Finding Phase: Dose-Normalized AUC (0-28) (AUC [0-28]/D) of Durvalumab
Dose-Finding Phase: Dose-Normalized Cmax (Cmax/D) of Durvalumab
Dose-Finding Phase: Cmax of Tremelimumab
Dose-Finding Phase: Cmin of Tremelimumab
Dose-Finding Phase: (AUC 0-14) of Tremelimumab
Dose-Finding Phase: (AUC 0-28) of Tremelimumab
Dose-Finding Phase: Tmax of Tremelimumab
Dose-Finding Phase: T½λz of Tremelimumab
Dose-Finding Phase: AUC (0-14)/D of Tremelimumab
Dose-Finding Phase: AUC (0-28)/D of Tremelimumab
Dose-Finding Phase: Cmax/D of Tremelimumab
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
Dose-Expansion Phase Only: Objective Response Rate (ORR)
Dose-Expansion Phase Only: Duration of Response (DOR)
Dose-Expansion Phase Only: Best Objective Response (BOR)
Dose-Expansion Phase Only: Disease Control Rate (DCR)
Dose-Expansion Phase Only: PFS
Dose-Expansion Phase Only: Overall Survival (OS)
Dose-Expansion Phase Only: Survival Rate at 12 Months and 24 Months
Dose-Expansion Phase: Cmax of Durvalumab
Dose-Expansion Phase: Cmin of Durvalumab
Dose-Expansion Phase: AUC (0-14) of Durvalumab
Dose-Expansion Phase: AUC (0-28) of Durvalumab
Dose-Expansion Phase: Tmax of Durvalumab
Dose-Expansion Phase: T½λz of Durvalumab
Dose-Expansion Phase: AUC (0-14)/D of Durvalumab
Dose-Expansion Phase: AUC (0-28)/D of Durvalumab
Dose-Expansion Phase: Cmax/D of Durvalumab
Dose-Expansion Phase: Cmax of Tremelimumab
Dose-Expansion Phase: Cmin of Tremelimumab
Dose-Expansion Phase: AUC (0-14) of Tremelimumab
Dose-Expansion Phase: AUC (0-28) of Tremelimumab
Dose-Expansion Phase: Tmax of Tremelimumab
Dose-Expansion Phase: T½λz of Tremelimumab
Dose-Expansion Phase: AUC (0-14)/D of Tremelimumab
Dose-Expansion Phase: AUC (0-28)/D of Tremelimumab
Dose-Expansion Phase: Cmax/D of Tremelimumab
Dose-Finding Phase: Percentage of Participants Who Developed Detectable Anti-Drug Antibodies (ADAs)
Dose-Expansion Phase: Percentage of Participants Who Developed Detectable ADAs
Number of Participants With Individual Antibody Titer Measurement
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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)
- healthy Volunteers
- false
- maximum Age
- 18 Years
- minimum Age
- 0 Years
- sex
- ALL
- std Ages
- CHILD
- ADULT
Treatment arms and interventions
- arm Groups
- description
- Part 1 (dose finding) Durvalumab + tremelimumab Combination Treatment. Durvalumab and tremelimumab are initially administered at dose level 1 and dose escalated based on results from PK modeling and tolerance to determine the RP2D. Both drugs are administered every 4 weeks as intravenous infusions. Tremelimumab is only administered with durvavalumab for 4 doses, from cycles 2-5. (sarcoma, NB and NHL) Part 2 (dose expansion phase) Durvalumab + tremelimumab Combination Treatment. Durvalumab and tremelimumab are administered at the RP2D, every 4 weeks as intravenous infusions. Tremelimumab is only administered with durvalumab for 4 doses, from cycles 1-4. Tremelimumab may be added for 4 doses at time of progressive disease. Cohorts: solid tumors, sarcomas, NHL restricted to PMBCL and ALCL subtypes)
- intervention Names
- Drug: Durvalumab / Tremelimumab Combination Therapy
- label
- Durvalumab / Tremelimumab Combination Therapy
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Durvalumab / Tremelimumab Combination Therapy
- description
- Starting dose: durvalumab: 20mg/kg tremelimumab: 1mg/kg at cycles 2 to 5 only co-administered with durvalumab. The Recommended Phase 2 dose will be used for the dose expansion phase.
- name
- Durvalumab / Tremelimumab Combination Therapy
- other Names
- durvalumab: Imfinzi, MEDI4736
- tremelimumab: CP-675,206
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 50
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.
- measure
- Dose-Finding Phase: Maximum Serum Concentration (Cmax) of Durvalumab
- time Frame
- 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
- description
- Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.
- measure
- Dose-Finding Phase: Minimum Serum Concentration (Cmin) of Durvalumab
- time Frame
- 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
- description
- Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.
- measure
- Dose-Finding Phase: Area Under the Serum Concentration-Time Curve (AUC) From Zero to 14 (AUC 0-14) of Durvalumab
- time Frame
- Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8
- description
- Serum samples were collected from the participants at the defined timepoints. AUC (0-28) was determined using standard non-compartmental methods.
- measure
- Dose-Finding Phase: AUC From Zero to 28 (AUC 0-28) of Durvalumab
- time Frame
- Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15
- description
- Serum samples were collected from the participants at the defined timepoints. Tmax was determined using standard non-compartmental methods.
- measure
- Dose-Finding Phase: Time to Cmax (Tmax) of Durvalumab
- time Frame
- 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
- description
- Serum samples were collected from the participants at the defined timepoints. T½λz was determined using standard non-compartmental methods.
- measure
- Dose-Finding Phase: Apparent Terminal Elimination Half-life Associated With the Terminal Slope of the Semi-logarithmic Concentration Time Curve (t½λz) of Durvalumab
- time Frame
- 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
- description
- Serum samples were collected from the participants at the defined timepoints. AUC(0-14)/D was determined using standard non-compartmental methods.
- measure
- Dose-Finding Phase: Dose-Normalized AUC (0-14) (AUC [0-14]/D) of Durvalumab
- time Frame
- Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8
- description
- Serum samples were collected from the participants at the defined timepoints. AUC(0-28)/D was determined using standard non-compartmental methods.
- measure
- Dose-Finding Phase: Dose-Normalized AUC (0-28) (AUC [0-28]/D) of Durvalumab
- time Frame
- Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15
- description
- Serum samples were collected from the participants at the defined timepoints. Cmax/D was determined using standard non-compartmental methods.
- measure
- Dose-Finding Phase: Dose-Normalized Cmax (Cmax/D) of Durvalumab
- time Frame
- 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
- description
- Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.
- measure
- Dose-Finding Phase: Cmax of Tremelimumab
- time Frame
- 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
- description
- Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.
- measure
- Dose-Finding Phase: Cmin of Tremelimumab
- time Frame
- 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
- description
- Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.
- measure
- Dose-Finding Phase: (AUC 0-14) of Tremelimumab
- time Frame
- Pre-infusion and post-infusion on Cycle 2 Day 1, and Cycle 2 Day 8
- secondary Outcomes
- description
- Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.
- measure
- Dose-Expansion Phase: Cmax of Durvalumab
- time Frame
- 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, 8, and 12
- description
- Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.
- measure
- Dose-Expansion Phase: Cmin of Durvalumab
- time Frame
- 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, 8, and 12
- description
- Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.
- measure
- Dose-Expansion Phase: AUC (0-14) of Durvalumab
- time Frame
- Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8
- description
- Serum samples were collected from the participants at the defined timepoints. AUC (0-28) was determined using standard non-compartmental methods.
- measure
- Dose-Expansion Phase: AUC (0-28) of Durvalumab
- time Frame
- Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15
- description
- Serum samples were collected from the participants at the defined timepoints. Tmax was determined using standard non-compartmental methods.
- measure
- Dose-Expansion Phase: Tmax of Durvalumab
- time Frame
- 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, 8, and 12
- description
- Serum samples were collected from the participants at the defined timepoints. T½λz was determined using standard non-compartmental methods.
- measure
- Dose-Expansion Phase: T½λz of Durvalumab
- time Frame
- 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, 8, and 12
- description
- Serum samples were collected from the participants at the defined timepoints. AUC (0-14)/D was determined using standard non-compartmental methods.
- measure
- Dose-Expansion Phase: AUC (0-14)/D of Durvalumab
- time Frame
- Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8
- description
- Serum samples were collected from the participants at the defined timepoints. AUC (0-28)/D was determined using standard non-compartmental methods.
- measure
- Dose-Expansion Phase: AUC (0-28)/D of Durvalumab
- time Frame
- Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15
- description
- Serum samples were collected from the participants at the defined timepoints. Cmax/D was determined using standard non-compartmental methods.
- measure
- Dose-Expansion Phase: Cmax/D of Durvalumab
- time Frame
- 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, 8, and 12
- description
- Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.
- measure
- Dose-Expansion Phase: Cmax of Tremelimumab
- time Frame
- 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, Cycle 3 Day 1 pre-infusion and post-infusion on Cycle 4
- description
- Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.
- measure
- Dose-Expansion Phase: Cmin of Tremelimumab
- time Frame
- 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, Cycle 3 Day 1 pre-infusion and post-infusion on Cycle 4
- description
- Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.
- measure
- Dose-Expansion Phase: AUC (0-14) of Tremelimumab
- time Frame
- Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8
Full study description
- brief 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.
- detailed 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
Source references
- references
- citation
- Hargrave D, Marshall LV, Andre N, Krystal J, Ladle BH, Robbins KA, Hois S, Armstrong J, Donegan S. Phase I/II, open-label, multicenter study of durvalumab in combination with tremelimumab in pediatric patients with advanced solid tumors. Front Oncol. 2026 May 15;16:1680081. doi: 10.3389/fonc.2026.1680081. eCollection 2026.
- pmid
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- type
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- see Also Links
- label
- Study Protocol
- label
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Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice