Durvalumab and tremelimumab for pediatric malignancies
Study identifier:D419EC00001
ClinicalTrials.gov identifier:NCT03837899
EudraCT identifier:2018-003118-42
CTIS identifier:N/A
Recruitment Complete
Official Title
Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or in Combination with Tremelimumab in Pediatric Patients with Advanced Solid Tumors and Hematological Malignancies.
Medical condition
Pediatric Cancer
Phase
Phase 1/2
Healthy volunteers
No
Study drug
Durvalumab / Tremelimumab Combination Therapy
Sex
All
Actual Enrollment
50
Study type
Interventional
Age
0 Years - 18 Years
Date
Study Start Date: 07 Mar 2019
Primary Completion Date: 28 Feb 2023
Estimated Study Completion Date: 30 Dec 2024
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Durvalumab / Tremelimumab Combination Therapy 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) | Drug: Durvalumab / Tremelimumab Combination Therapy 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. Other Name: durvalumab: Imfinzi, MEDI4736 Other Name: tremelimumab: CP-675,206 |
Contacts
Investigators
Principal Investigator
Ashok Gupta
AstraZeneca Global Medicines Development, Academy House
