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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Atezolizumab was administered as IV infusion (maximum 1200 mg) on Day 1 of each 21-day cycle.
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
Note: In Cohort 5, the response was observed in a rhabdoid tumor. Participant was erroneously enrolled in the Non-rhabdomyosarcoma soft tissue sarcoma cohort.
Time frame: Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
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 42 months)
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 42 months)
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 42 months)
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 42 months)
Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1 in Participants With Solid Tumors
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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
...and 20 more locations
Time frame: Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)
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 42 months)
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 42 months)
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 42 months)
Percentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Time frame: From baseline up to approximately 42 months
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 42 months)
Atezolizumab Serum Concentration at Washout
Time frame: At least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)
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 42 months)
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 42 months)
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 42 months)
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 42 months)
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 42 months)
Overall Survival (OS)
Time frame: Baseline until death (up to approximately 42 months)
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 42 months)
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 42 months)
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 42 months)
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 42 months)
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 42 months)
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 42 months)
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 42 months)
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 42 months)
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 42 months)
Optimal Dose of Atezolizumab in Pediatric Adult Participants
Atezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.
Time frame: From baseline up to approximately 42 months
Optimal Dose of Atezolizumab in Young Adult Participants
Atezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.
Time frame: From baseline up to approximately 42 months