Phase I/II Study of Avelumab in Pediatric Cancer Participants
NCT ID: NCT03451825
Last Updated: 2024-06-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
21 participants
INTERVENTIONAL
2018-03-07
2021-07-27
Brief Summary
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The study was planned to be conducted in 2 parts: the dose-finding part (Phase I) and the tumor-specified expansion part (Phase II). However, Phase II was cancelled due to limited clinical benefit of PD-L1 monotherapy in pediatric participants.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Avelumab: 10 miligram per kilogram (mg/kg)
Avelumab
Participants received an intravenous infusion of avelumab 10mg/kg intervention (IV) once every 2 weeks until confirmed progression, death, unacceptable toxicity, or any criterion for withdrawal occurred.
Avelumab 20mg/kg
Avelumab
Participants received an intravenous infusion of avelumab 20mg/kg intervention (IV) once every 2 weeks until confirmed progression, death, unacceptable toxicity, or any criterion for withdrawal occurred.
Interventions
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Avelumab
Participants received an intravenous infusion of avelumab 10mg/kg intervention (IV) once every 2 weeks until confirmed progression, death, unacceptable toxicity, or any criterion for withdrawal occurred.
Avelumab
Participants received an intravenous infusion of avelumab 20mg/kg intervention (IV) once every 2 weeks until confirmed progression, death, unacceptable toxicity, or any criterion for withdrawal occurred.
Eligibility Criteria
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Inclusion Criteria
* Confirmed progression on or refractory to standard therapy or no standard therapy available.
* Availability of archival formalin-fixed, paraffin-embedded block containing tumor tissue, or slides, or a fresh/recent tumor biopsy prior to avelumab treatment for subjects in Phase 2
* Adequate bone marrow, kidney, and liver function
Exclusion Criteria
* Concurrent anticancer treatment or immunosuppressive agents
* Prior organ transplantation
* Significant acute or chronic infections
* Other significant diseases or conditions that might impair the subject's tolerance of trial treatment
0 Years
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
The Children's Hospital at Montefiore (CHAM)
The Bronx, New York, United States
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Children's Hospital - London Health Sciences Centre
London, , Canada
CHU Sainte-Justine
Montreal, , Canada
The Hospital for Sick Children
Toronto, , Canada
Rigshospitalet
Copenhagen, , Denmark
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Countries
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References
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Vugmeyster Y, Grisic AM, Brockhaus B, Rueckert P, Ruisi M, Dai H, Khandelwal A. Avelumab Dose Selection for Clinical Studies in Pediatric Patients with Solid Tumors. Clin Pharmacokinet. 2022 Jul;61(7):985-995. doi: 10.1007/s40262-022-01111-8. Epub 2022 Apr 29.
Loeb DM, Lee JW, Morgenstern DA, Samson Y, Uyttebroeck A, Lyu CJ, Van Damme A, Nysom K, Macy ME, Zorzi AP, Xiong J, Pollert P, Joerg I, Vugmeyster Y, Ruisi M, Kang HJ. Avelumab in paediatric patients with refractory or relapsed solid tumours: dose-escalation results from an open-label, single-arm, phase 1/2 trial. Cancer Immunol Immunother. 2022 Oct;71(10):2485-2495. doi: 10.1007/s00262-022-03159-8. Epub 2022 Mar 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2017-002985-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS100070-0306
Identifier Type: -
Identifier Source: org_study_id
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