Study identifier:D419EC00001
ClinicalTrials.gov identifier:NCT03837899
EudraCT identifier:2018-003118-42
CTIS identifier:N/A
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.
Pediatric Cancer
Phase 1/2
No
Durvalumab / Tremelimumab Combination Therapy
All
56
Interventional
0 Years - 18 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2024 by AstraZeneca
AstraZeneca
-
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 |