{"entity":{"id":"nct03837899","kind":"trial","name":"Durvalumab and Tremelimumab for Pediatric Malignancies","aka":[],"tldr":"A phase 1/2 trial of Durvalumab and Tremelimumab in childhood cancers, run by AstraZeneca, active and no longer recruiting.","summary":"Durvalumab and Tremelimumab for Pediatric Malignancies is a phase 1/2 interventional study registered as NCT03837899 by AstraZeneca, with 50 participants enrolled, started 2019-03-07 and due to reach its primary completion in 2023-02-28. Interventions recorded: Durvalumab / Tremelimumab Combination Therapy. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03837899","url":"https://clinicaltrials.gov/study/NCT03837899"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["childhood-cancers"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03837899","phase":"1/2","setting":"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.","sponsor":"AstraZeneca","started":"2019-03-07","startedType":"actual","yearReported":2024,"enrolled":50,"enrolledBasis":"registry","outcomes":[{"endpoint":"Dose-Expansion Phase Only: Objective Response Rate (ORR)","primary":true,"unit":"%","arms":[{"name":"SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg","n":11,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2024-03-19), not from a publication"},{"name":"STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg","n":9,"value":11.1}],"source":"https://clinicaltrials.gov/study/NCT03837899?tab=results"},{"endpoint":"Dose-Expansion Phase Only: Duration of Response (DOR)","primary":true,"unit":"months","arms":[{"name":"STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg","n":1,"value":10.8,"note":"range 10.8 to 10.8; Figures from the ClinicalTrials.gov results section (first posted 2024-03-19), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT03837899?tab=results"},{"endpoint":"Dose-Expansion Phase Only: PFS","primary":true,"unit":"months","arms":[{"name":"SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg","n":11,"value":1.7,"note":"90% CI 1.58 to 1.91; Figures from the ClinicalTrials.gov results section (first posted 2024-03-19), not from a publication"},{"name":"STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg","n":10,"value":1.7,"note":"90% CI 0.89 to 2.76"}],"source":"https://clinicaltrials.gov/study/NCT03837899?tab=results"}]},"route":"/trials/nct03837899/","neighbours":{"cancer":[{"id":"childhood-cancers","kind":"cancer","name":"Childhood cancers (all types)","route":"/cancers/childhood-cancers/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"tremelimumab","kind":"drug","name":"Tremelimumab","route":"/drugs/tremelimumab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}