Phase I/II study of avelumab in pediatric cancer subjects

Phase 1

• Conditions: Solid tumors (including central nervous system tumors) and lymphoma; MedDRA version: 20.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10025632Term: Malignant lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002985-28-BE
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-15
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

Male or female subjects 0 to < 18 years of age at the time of first treatment dose with histologically or cytologically confirmed solid malignant tumors or lymphoma; confirmed progression on or refractory to standard therapy or no standard therapy available; availability of archival formalinfixed, paraffin-embedded block containing tumor tissue, or slides, or a fresh/recent tumor biopsy prior to avelumab treatment; adequate bone marrow, kidney, and liver function.
Are the trial subjects under 18? yes
Number of subjects for this age range: 148
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified