Durvalumab and Tremelimumab for Pediatric Malignancies

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
AstraZeneca
Study ID
NCT03837899
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Hematological Malignancies
  • Pediatric Cancer
  • Solid Tumor Pediatric

Eligibility Criteria

Sex
ALL
Age
0 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab / Tremelimumab Combination Therapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 7, 2019
Status verified
Apr 2026
Primary completion
Feb 28, 2023
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome 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 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteBaltimoreMaryland21231-
Research SiteBostonMassachusetts02115-
Research SiteNew Hyde ParkNew York11040-
Research SiteOklahoma CityOklahoma73104-
Research SiteCharlestonSouth Carolina29425-

Find similar trials in Baltimore, MD

By research site
Research Site· Baltimore, MDResearch Site· Boston, MAResearch Site· New Hyde Park, NYResearch Site· Oklahoma City, OKResearch Site· Charleston, SC

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