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Phase I/II Study of Avelumab in Pediatric Cancer Participants | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Phase I/II Study of Avelumab in Pediatric Cancer Participants

Open-label, Phase I/II Study to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Anticancer Activity of Avelumab in Pediatric Subjects From Birth to Less Than 18 Years of Age With Refractory or Relapsed Solid Tumors and Lymphoma

NCT03451825•EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

This is a multi-center, open-label, international study to evaluate the dose, safety and tolerability, antitumor activity, pharmacokinetic and pharmacodynamics of avelumab in pediatric subjects 0 to less than 18 years of age with refractory or relapsed malignant solid tumors (including central nervous system tumors) and lymphoma for which no standard therapy is available or for which the subject is not eligible for the existing therapy. 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.

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects 0 to less than 18 years of age at the time of first treatment dose with histologically or cytologically confirmed solid malignant tumors (including CNS tumors) or lymphoma for which no standard therapy is available
•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

•Prior therapy with any antibody or drug targeting T-cell coregulatory proteins
•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

Locations (11)

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

Key Dates

Start Date

March 7, 2018

Primary Completion Date

July 27, 2021

Completion Date

July 27, 2021

Last Updated

June 24, 2024

Enrollment

ACTUAL participants

Conditions

Refractory or Relapsed Solid TumorsLymphoma

Interventions

Avelumab

DRUG

Avelumab

DRUG

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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RECRUITINGPHASE3

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

NCT06337318

Classic Follicular LymphomaFollicular Lymphoma With Unusual Cytological Features

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase I/II Study of Avelumab in Pediatric Cancer Participants

Inclusion Criteria

Exclusion Criteria

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

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