Overview
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Pediatric and Young Adult Participants With Solid Tumors
Status:
Terminated
Terminated
Trial end date:
2019-06-06
2019-06-06
Target enrollment:
0
0
Participant gender:
All
All
Summary
This early phase, multicenter, open-label, single-arm study evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of atezolizumab in pediatric and young adult participants with solid tumors for which prior treatment was proven to be ineffective.Phase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hoffmann-La RocheTreatments:
Antibodies
Antibodies, Monoclonal
Atezolizumab
Criteria
Inclusion Criteria:- Pediatric solid tumor (including Hodgkin's and Non-Hodgkin's lymphoma), for which
prior treatment had proven to be ineffective (that is, relapsed or refractory) or
intolerable
- Disease that is measurable as defined by RECIST v1.1, mINRC, Revised Response Criteria
for Malignant Lymphoma, RANO criteria (as appropriate) or evaluable by nuclear
medicine techniques, immunocytochemistry techniques, tumor markers, or other reliable
measures
- Archival tumor tissue block or 15 freshly cut, unstained, serial slides available for
submission, or willingness to undergo a core or excisional biopsy prior to enrollment
(fine-needle aspiration, brush biopsy, and lavage samples are not acceptable).
Participants with fewer than 15 slides available may be eligible for study entry following
discussion with Medical Monitor
- Lansky Performance Status (participants less than [<] 16 years old) or Karnofsky
Performance Status (participants greater than or equal to [>=] 16 years old) >=50
- Life expectancy >=3 months, in the investigator's judgment
- Adequate hematologic and end organ function, confirmed by laboratory results obtained
within 28 days prior to initiation of study drug
Exclusion Criteria:
- Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases,
except ATRT
- Treatment with high-dose chemotherapy and hematopoietic stem-cell rescue within 3
months prior to initiation of study drug
- Prior allogeneic hematopoietic stem-cell transplantation or prior solid-organ
transplantation
- Treatment with chemotherapy (other than high-dose chemotherapy as described above) or
differentiation therapy (such as retinoic acid) or immunotherapy (such as anti-GD2
antibody treatment) within 3 weeks prior to initiation of study drug or, if treatment
included nitrosoureas, within 6 weeks prior to initiation of study drug
- Treatment with thoracic or mediastinal radiotherapy within 3 weeks prior to initiation
of study drug
- Treatment with hormonal therapy (except hormone replacement therapy or oral
contraceptives) or biologic therapy within 4 weeks or 5 half-lives, whichever is
shorter, prior to initiation of study drug. This requirement may be waived at the
investigator's request if the participant has recovered from therapeutic toxicity to
the degree specified in the protocol, with approval of the Medical Monitor
- Treatment with a long-acting hematopoietic growth factor within 2 weeks prior to
initiation of study drug or a short-acting hematopoietic growth factor within 1 week
prior to initiation of study drug
- Treatment with investigational therapy (with the exception of cancer therapies as
described above) within 4 weeks prior to initiation of study drug
- Treatment with a live vaccine or a live, attenuated vaccine (e.g., nasal spray of live
attenuated influenza vaccine or FluMistĀ®) within 4 weeks prior to initiation of study
drug or anticipation that such treatment will be required during the study or within 5
months after the final dose of study drug
- Treatment with herbal cancer therapy within 1 week prior to initiation of study drug
- Prior treatment with cluster of differentiation 137 (CD137) agonists or immune
checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated
protein 4 (anti-CTLA4), anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic
antibodies
- Treatment with systemic immunostimulatory agents (including but not limited to
interferons or interleukin 2 [IL-2]) within 6 weeks or five drug elimination
half-lives prior to Day 1 of Cycle 1, whichever is longer
- Treatment with systemic corticosteroids or other systemic immunosuppressive
medications (including but not limited to prednisone, dexamethasone, cyclophosphamide,
azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents)
at the time of initiation of study drug, or anticipated requirement for systemic
immunosuppressive medications during the study
- Current treatment with therapeutic anticoagulants
- Any non-hematologic toxicity (excluding alopecia) from prior treatment that has not
resolved to Grade less than or equal to (<=) 1 (per National Cancer Institute Common
Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0) at screening
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells
or any component of the atezolizumab formulation