Phase I/II Study of Avelumab in Pediatric Cancer Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 3/7/2019 |
| Start Date: | March 7, 2018 |
| End Date: | June 9, 2022 |
| Contact: | US Medical Information |
| Email: | service@emdgroup.com |
| Phone: | 888-275-7376 |
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
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.
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.
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
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