Phase I/II Study of Avelumab in Pediatric Cancer Subjects

Official Title

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 Tumours and Lymphoma

Summary:

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

Trial Description

Primary Outcome:

  • Phase 1: Occurrence and Severity of Grade 3 or Higher Treatment Emergent Adverse Events (TEAEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.03)
  • Phase 1: Occurrence of Dose Limiting Toxicity
  • Phase 2: Confirmed Best Overall Response (BOR) as per Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) and as Adjudicated by the Investigator
Secondary Outcome:
  • Phase 1: Confirmed Best Overall Response (BOR) as per Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) and as Adjudicated by the Investigator
  • Phase 1 and Phase 2: Duration of Response (DOR) as per Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) and as Adjudicated by the Investigator
  • Phase 1 and Phase 2: Time to Response According to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) and as Adjudicated by the Investigator
  • Phase 1 and Phase 2: Progression-Free Survival According to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) and as Adjudicated by the Investigator
  • Phase 1 and Phase 2: Overall Survival (OS) Time
  • Phase 1 and Phase 2: Occurrence and Severity of Treatment Emergent Adverse Events (TEAEs), AEs of Special Interest, and Treatment-Related AEs, According to the NCI-CTCAE Version 4.03
  • Phase 1 and Phase 2: Incidence of Laboratory Abnormalities as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
  • Phase 1 and Phase 2: Maximum Observed Plasma Concentration (Cmax) of Single and Multiple Dose of Avelumab
  • Phase 1 and Phase 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of Avelumab
  • Phase 1 and Phase 2: Half life (t1/2) of Single and Multiple Dose of Avelumab
  • Phase 1 and Phase 2: Minimum Post-dose Trough Concentration of Single and Multiple Dose of Avelumab
  • Phase 1 and Phase 2: Immunogenicity as measured by Incidence of Antidrug Antibody (ADA) and Neutralizing Antibody (Nabs)
  • Phase 1 and Phase 2: Tumour Programmed Death Ligand 1 (PD-L1) Expression Levels
  • Phase 1 and Phase 2: Tumour-Infiltrating T-cell Levels
  • Phase 1 and Phase 2: T-cell Population in Blood
  • Phase 1 and Phase 2: Number of T-cell, B-cell and NK-cell in Blood
  • Phase 1 and Phase 2: Vaccination-Related Antibody Concentrations
  • Phase 1 and Phase 2: Body Temperature
  • Phase 1 and Phase 2: Heart Rate
  • Phase 1 and Phase 2: Respiratory Rate
  • Phase 1 and Phase 2: Systolic and Diastolic Blood Pressure

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society