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.
Durvalumab / Tremelimumab Combination Therapy
0 Years - 18 Years
Endpoint Classification: -
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Verified 01 Nov 2023 by AstraZeneca
No locations available
|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