EUCTR2017-002985-28-BE
Active, not recruiting
Phase 1
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 - N/A
ConditionsSolid tumors (including central nervous system tumors) and lymphomaMedDRA version: 20.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10025632Term: Malignant lymphomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsBAVENCIO
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Solid tumors (including central nervous system tumors) and lymphoma
- Sponsor
- Merck KGaA
- Enrollment
- 148
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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