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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

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02541604
First received: August 18, 2015
Last updated: July 10, 2017
Last verified: July 2017
  Purpose
This early phase, multicenter, open-label, single-arm study will evaluate 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.

Condition Intervention Phase
Solid Tumor Drug: Atezolizumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Early-Phase, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) In Pediatric and Young Adult Patients With Previously Treated Solid Tumors

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Participants With Solid Tumors [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Modified International Neuroblastoma Response Criteria (mINRC) in Participants With Neuroblastoma [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Response Assessment in Neuro-Oncology (RANO) Criteria in Participants With Atypical Teratoid Rhabdoid Tumor (ATRT) [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • Percentage of Participants With Clinical Benefit as Determined by the Investigator According to RECIST v1.1 Criteria in Participants With Osteosarcoma [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1 in Participants With Solid Tumors [ Time Frame: Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • PFS as Determined by the Investigator Using mINRC in Participants With Neuroblastoma [ Time Frame: Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • PFS as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma [ Time Frame: Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • PFS as Determined by the Investigator Using RANO Criteria in Participants With ATRT [ Time Frame: Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • Percentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest [ Time Frame: From baseline up to approximately 7.5 years ]
  • Maximum Serum Concentration (Cmax) of Atezolizumab [ Time Frame: Predose (PRD; 0 hours [hr]), 0.5 hr post-infusion (P-I; infusion duration=30-60 minutes) on Day (D) 1 of Cycle (Cy) 1 and 4 (1 Cy=21 days) ]
  • Minimum Serum Concentration (Cmin) of Atezolizumab [ Time Frame: PRD (0 hr) on D1 of Cy2,3,4,8, 12, 16 (1 Cy=21 days) and every 8 cycles thereafter; at any time during visit at study drug discontinuation visit, at least 90 days (maximum 150 days) after the last dose of study drug (up to approximately 7.5 years) ]
  • Atezolizumab Serum Concentration at Washout [ Time Frame: At least 90 days (maximum 150 days) after last dose of study drug (up to approximately 7.5 years) ]
  • Area Under the Concentration-Time Curve (AUC) of Atezolizumab [ Time Frame: PRD (0 hr), 0.5 hr P-I (infusion duration=30-60 minutes) on D1 of Cy1; at any time during visit on Cy1D8 (1 Cy=21 days) ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [ Time Frame: PRD (0 hr) on D1 of Cy1,2,3,4,8,12,16 (1 Cy=21 days) & every 8 cycles thereafter; at any time during visit on Cy1D8, study drug discontinuation, at least 90 days (maximum 150 days) after last dose of study drug (up to approximately 7.5 years) ]

Secondary Outcome Measures:
  • Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 Criteria in Participants With Solid Tumors [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • DOR as Determined by the Investigator Using mINRC in Participants With Neuroblastoma [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • DOR as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • DOR as Determined by the Investigator Using RANO Criteria in Participants With ATRT [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • Overall Survival (OS) [ Time Frame: Baseline until death (up to approximately 7.5 years) ]
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Related Response Criteria (irRC) for Participants With Neuroblastoma [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • PFS as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • PFS as Determined by the Investigator Using irRC for Participants With Neuroblastoma [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • PFS as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • DOR as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • DOR as Determined by the Investigator Using irRC for Participants With Neuroblastoma [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • DOR as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma [ Time Frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 7.5 years) ]
  • Optimal Dose of Atezolizumab in Pediatric and Young Adult Participants [ Time Frame: From baseline up to approximately 7.5 years ]

Estimated Enrollment: 100
Actual Study Start Date: November 30, 2015
Estimated Study Completion Date: January 31, 2022
Estimated Primary Completion Date: January 31, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atezolizumab
Participants will receive intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams [mg]) on Day 1 of each 21-day cycle.
Drug: Atezolizumab
Atezolizumab will be administered as IV infusion (maximum 1200 mg) on Day 1 of each 21-day cycle.
Other Name: RO5541267; MPDL3280A; Tecentriq

  Eligibility

Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02541604

Contacts
Contact: Reference Study ID Number: GO29664 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 58 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02541604     History of Changes
Other Study ID Numbers: GO29664
2014-004697-41 ( EudraCT Number )
Study First Received: August 18, 2015
Last Updated: July 10, 2017

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2017