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ACTIVE NOT RECRUITING
NCT03837899
PHASE1/PHASE2

Durvalumab and Tremelimumab for Pediatric Malignancies

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

0 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2019-03-07

Completion Date

2024-12-30

Last Updated

2024-10-29

Healthy Volunteers

No

Interventions

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.

Locations (19)

Research Site

Baltimore, Maryland, United States

Research Site

Boston, Massachusetts, United States

Research Site

New Hyde Park, New York, United States

Research Site

Oklahoma City, Oklahoma, United States

Research Site

Charleston, South Carolina, United States

Research Site

Lille, France

Research Site

Marseille, France

Research Site

Paris, France

Research Site

Cologne, Germany

Research Site

Genova, Italy

Research Site

Milan, Italy

Research Site

Rome, Italy

Research Site

Torino, Italy

Research Site

Utrecht, Netherlands

Research Site

Barcelona, Spain

Research Site

Madrid, Spain

Research Site

Leeds, United Kingdom

Research Site

London, United Kingdom

Research Site

Sutton, United Kingdom