Status:
TERMINATED
Phase I/II Study of Avelumab in Pediatric Cancer Participants
Lead Sponsor:
EMD Serono Research & Development Institute, Inc.
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Refractory or Relapsed Solid Tumors
Lymphoma
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
Brief Summary
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03451825
Start Date
March 7 2018
End Date
July 27 2021
Last Update
June 24 2024
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
The Children's Hospital at Montefiore (CHAM)
The Bronx, New York, United States, 10467
3
Cliniques Universitaires Saint-Luc
Brussels, Belgium
4
UZ Leuven
Leuven, Belgium