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Purpose

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.

Conditions

Eligibility

Eligible Ages
Under 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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
  • Other protocol defined inclusion criteria could apply

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
  • Other protocol defined exclusion criteria could apply

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1: Avelumab
  • Drug: Avelumab
    Subjects will receive avelumab administered intravenously (IV) once every 2 weeks.
Experimental
Phase 2, Cohort 1: Avelumab
  • Drug: Avelumab
    Subjects will receive avelumab at a recommended phase II dose (RP2D) adjudicated by a safety monitoring committee (SMC) from phase I part of the study.
Experimental
Phase 2, Cohort 2: Avelumab
  • Drug: Avelumab
    Subjects will receive avelumab at a recommended phase II dose (RP2D) adjudicated by a safety monitoring committee (SMC) from phase I part of the study.

Recruiting Locations

The Children's Hospital at Montefiore (CHAM)
Bronx, New York 10467

More Details

Status
Recruiting
Sponsor
EMD Serono Research & Development Institute, Inc.

Study Contact

US Medical Information
888-275-7376
service@emdgroup.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.