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
NCT ID: NCT02541604
Last Updated: 2020-02-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
87 participants
INTERVENTIONAL
2015-11-30
2019-06-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Atezolizumab
Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams \[mg\]) on Day 1 of each 21-day cycle.
Atezolizumab
Atezolizumab was administered as IV infusion (maximum 1200 mg) on Day 1 of each 21-day cycle.
Interventions
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Atezolizumab
Atezolizumab was administered as IV infusion (maximum 1200 mg) on Day 1 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 FluMist®) 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
30 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Stanford University/Lucile Packard Children's Hospital
Palo Alto, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Alberta Children'S Hospital
Calgary, Alberta, Canada
Rigshospitalet; BØRNEUNGEKLINIKKEN, Ambulatoriet for kræft- og Blodsygdomme hos børn og unge
København Ø, , Denmark
Centre Léon Bérard, Institut d'Hémato-Oncologie Pédiatrique
Lyon, , France
Institut Curie, Oncologie Pédiatrique
Paris, , France
Institut Gustave Roussy; Service Pediatrique
Villejuif, , France
Klinik Johann Wolfgang von Goethe Uni
Frankfurt, , Germany
Schneider Children's Medical Center
Petah Tikva, , Israel
Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica
Rome, Lazio, Italy
IRCCS Istituto Giannina Gaslini; Unità Operativa Oncologica Pediatrica
Genoa, Liguria, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica
Milan, Lombardy, Italy
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica
Padua, Veneto, Italy
Erasmus MC / location Sophia Kinderziekenhuis
Rotterdam, , Netherlands
Hospital Sant Joan De Deu
Esplugues de Llobregas, Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Infantil Universitario Nino Jesus
Madrid, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Universitäts-Kinderspital; Abteilung für Onkologie
Zurich, , Switzerland
Birmingham Children's Hospital
Birmingham, , United Kingdom
Bristol Royal Hospital For Children
Bristol, , United Kingdom
Leeds General Infirmary; Paediatric Oncology & Haematology
Leeds, , United Kingdom
The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit
Newcastle upon Tyne, , United Kingdom
Royal Marsden Hospital; Pediatric Unit
Surrey, , United Kingdom
Countries
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References
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Nabbi A, Danesh A, Espin-Garcia O, Pedersen S, Wellum J, Fu LH, Paulson JN, Geoerger B, Marshall LV, Trippett T, Rossato G, Pugh TJ, Hutchinson KE. Multimodal immunogenomic biomarker analysis of tumors from pediatric patients enrolled to a phase 1-2 study of single-agent atezolizumab. Nat Cancer. 2023 Apr;4(4):502-515. doi: 10.1038/s43018-023-00534-x. Epub 2023 Apr 10.
Geoerger B, Zwaan CM, Marshall LV, Michon J, Bourdeaut F, Casanova M, Corradini N, Rossato G, Farid-Kapadia M, Shemesh CS, Hutchinson KE, Donaldson F, Liao M, Caron H, Trippett T. Atezolizumab for children and young adults with previously treated solid tumours, non-Hodgkin lymphoma, and Hodgkin lymphoma (iMATRIX): a multicentre phase 1-2 study. Lancet Oncol. 2020 Jan;21(1):134-144. doi: 10.1016/S1470-2045(19)30693-X. Epub 2019 Nov 25.
Shemesh CS, Chanu P, Jamsen K, Wada R, Rossato G, Donaldson F, Garg A, Winter H, Ruppel J, Wang X, Bruno R, Jin J, Girish S. Population pharmacokinetics, exposure-safety, and immunogenicity of atezolizumab in pediatric and young adult patients with cancer. J Immunother Cancer. 2019 Nov 21;7(1):314. doi: 10.1186/s40425-019-0791-x.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2014-004697-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO29664
Identifier Type: -
Identifier Source: org_study_id
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