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TerminatedNCT02541604Updated Feb 25, 2020Results posted

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

A Phase 1/2 interventional study of Atezolizumab in Solid Tumor, sponsored by Hoffmann-La Roche. Terminated at 30 sites in 11 countries. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2020-02-25.

Sponsored by Hoffmann-La Roche · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Sponsor decision to terminate because limited investigational agent activity was observed.
Phase
Phase 1/2
Study type
Interventional
Enrollment
87
Allocation
Not applicable
Ages
Up to 30 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Tumor

Browse trials for

03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 87 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    Atezolizumab

    Participants received intravenous (IV) infusion of atezolizumab (maximum 1200 milligrams \[mg\]) on Day 1 of each 21-day cycle.

    Drug: Atezolizumab

Interventions

  • DrugAtezolizumab

    Atezolizumab was administered as IV infusion (maximum 1200 mg) on Day 1 of each 21-day cycle.

    Also known as: RO5541267; MPDL3280A; Tecentriq

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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 42 months)

  7. 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)

  8. 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)

  9. 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)

  10. Percentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest

    Time frame: From baseline up to approximately 42 months

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Overall Survival (OS)

    Time frame: Baseline until death (up to approximately 42 months)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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

  16. 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

07

Results

Posted Feb 25, 2020

Participant flow

Participant flow — Overall Study
MilestoneCOHORT 1COHORT 2COHORT 3COHORT 4COHORT 5COHORT 6COHORT 7COHORT 8COHORT 9COHORT 10COHORT 11COHORT 12
Started119113101010104423
Completed000000000000
Not completed119113101010104423
Withdrew: Death657298993423
Withdrew: Lost to follow-up201001100000
Withdrew: Withdrawal by subject201011001000
Withdrew: Study terminated by sponsor142100000000
Withdrew: Medical condition may jeopardize safety000000010000

Outcome measures

PrimaryPercentage 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)
Reported as:
Number · Percentage
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
PercentageCohort 1Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11
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 Tumors010.0000000
PrimaryPercentage 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)
Reported as:
Number · Percentage
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
PercentageCohort 3
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 Neuroblastoma0
PrimaryPercentage 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)
Reported as:
Number · Percentage
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
PercentageCohort 2Cohort 4
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 Lymphoma22.233.3
PrimaryPercentage 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)
Reported as:
Number · Percentage
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)
PercentageCohort 12
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)0
PrimaryPercentage 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)
Reported as:
Number · Percentage
Percentage of Participants With Clinical Benefit as Determined by the Investigator According to RECIST v1.1 Criteria in Participants With Osteosarcoma
PercentageCohort 6
Percentage of Participants With Clinical Benefit as Determined by the Investigator According to RECIST v1.1 Criteria in Participants With Osteosarcoma0
PrimaryProgression-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 42 months)
Reported as:
Median · Months
Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1 in Participants With Solid Tumors
MonthsCohort 1Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11
Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1 in Participants With Solid Tumors1.2 (0.6 to 1.4)1.3 (1.1 to 1.4)1.2 (0.7 to 1.8)1.1 (0.8 to 1.3)1.3 (1.1 to 1.5)1.2 (0.7 to 1.3)1.2 (1.1 to 10.1)0.7 (0.3 to 1.1)
PrimaryPFS 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)
Reported as:
Median · Months
PFS as Determined by the Investigator Using mINRC in Participants With Neuroblastoma
MonthsCohort 3
PFS as Determined by the Investigator Using mINRC in Participants With Neuroblastoma2.6 (1.2 to 4.7)
PrimaryPFS 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)
Reported as:
Median · 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
MonthsCohort 2Cohort 4
PFS as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma2.8 (2.6 to 4.4)1.4 (1.1 to NA)
PrimaryPFS 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)
Reported as:
Median · Months
PFS as Determined by the Investigator Using RANO Criteria in Participants With ATRT
MonthsCohort 12
PFS as Determined by the Investigator Using RANO Criteria in Participants With ATRT1.4 (1.4 to 1.7)
PrimaryPercentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Time frame:
From baseline up to approximately 42 months
Reported as:
Number · Percentage
Percentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
PercentageAtezolizumab
Adverse Events97.7
Serious Adverse Events37.9
Adverse Events of Special Interest44.8
PrimaryMaximum 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)
Reported as:
Geometric mean · ug/mL
Maximum Serum Concentration (Cmax) of Atezolizumab
ug/mL<2 Age (Years)2 to <12 Age (Years)12 to <18 Age (Years)>=18 Age (Years)
Cycle 1105 ± 6.90312 ± 28.7337 ± 26.8424 ± 26.9
Cycle 4—382 ± 16.4373 ± 78.9626 ± 29.2
PrimaryMinimum 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)
Reported as:
Geometric mean · ug/mL
Minimum Serum Concentration (Cmin) of Atezolizumab
ug/mL<2 Age (Years)2 to <12 Age (Years)12 to <18 Age (Years)>=18 Age (Years)
Cycle 224.1 ± NA59.3 ± 31.456.5 ± 50.479.9 ± 52.7
Cycle 3—58.9 ± 234.485.0 ± 47.4148 ± 48.9
Cycle 4—99.2 ± 36.4113 ± 41.1121 ± 80.4
Cycle 8—166 ± 19.8145 ± 21.9209 ± 8.10
PrimaryAtezolizumab Serum Concentration at Washout
Time frame:
At least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)
Reported as:
Geometric mean · ug/mL
Atezolizumab Serum Concentration at Washout
ug/mLAtezolizumab
Atezolizumab Serum Concentration at Washout1.91 ± 2815.1
PrimaryArea 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)
Reported as:
Geometric mean · ugxday/mL
Area Under the Concentration-Time Curve (AUC) of Atezolizumab
ugxday/mL<2 Age (Years)2 to <12 Age (Years)12 to <18 Age (Years)>=18 Age (Years)
Area Under the Concentration-Time Curve (AUC) of Atezolizumab1130 ± 5.282209 ± 21.32816 ± 17.73579 ± 28.4
PrimaryPercentage 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)
Reported as:
Number · Percentage
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
PercentageAtezolizumab
Baseline2.6
Post-baseline14.3
SecondaryDuration 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)
Reported as:
Median · Months
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 Criteria in Participants With Solid Tumors
MonthsCohort 1Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 Criteria in Participants With Solid Tumors—13.2 (NA to NA)——————
SecondaryDOR 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)

No measurements were reported for this outcome.

SecondaryDOR 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)
Reported as:
Median · 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
MonthsCohort 2Cohort 4
DOR as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's LymphomaNA (4.1 to NA)NA (NA to NA)
SecondaryDOR 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)

No measurements were reported for this outcome.

SecondaryOverall Survival (OS)
Time frame:
Baseline until death (up to approximately 42 months)
Reported as:
Median · Months
Overall Survival (OS)
MonthsAtezolizumab
Overall Survival (OS)7.4 (5.3 to 9.6)
SecondaryPercentage 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)
Reported as:
Number · Percentage
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
PercentageCohort 1Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12
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 Tumors0100000000
SecondaryPercentage 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)
Reported as:
Number · Percentage
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
PercentageCohort 3
Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Related Response Criteria (irRC) for Participants With Neuroblastoma0
SecondaryPercentage 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)
Reported as:
Number · Percentage
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
PercentageCohort 2Cohort 4
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 Lymphoma33.333.3
SecondaryPFS 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)
Reported as:
Median · Months
PFS as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
MonthsCohort 1Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12
PFS as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors1.3 (0.6 to 1.4)1.4 (1.3 to 3.7)1.2 (0.9 to 1.8)1.3 (1.1 to 1.8)1.4 (1.1 to 2.8)1.2 (0.7 to 1.3)1.2 (1.1 to 10.1)0.7 (0.3 to 1.1)6.9 (1.7 to 9.3)
SecondaryPFS 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)
Reported as:
Median · Months
PFS as Determined by the Investigator Using irRC for Participants With Neuroblastoma
MonthsCohort 3
PFS as Determined by the Investigator Using irRC for Participants With Neuroblastoma6.9 (2.6 to 14.7)
SecondaryPFS 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)
Reported as:
Median · Months
PFS as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
MonthsCohort 2Cohort 4
PFS as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma6.5 (2.6 to NA)3.7 (1.4 to NA)
SecondaryDOR 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)
Reported as:
Median · Months
DOR as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
MonthsCohort 1Cohort 5Cohort 6Cohort 7Cohort 8Cohort 9Cohort 10Cohort 11Cohort 12
DOR as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors—13.2 (NA to NA)———————
SecondaryDOR 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)

No measurements were reported for this outcome.

SecondaryDOR 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)
Reported as:
Median · Months
DOR as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
MonthsCohort 2Cohort 4
DOR as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's LymphomaNA (7.3 to NA)NA (NA to NA)
SecondaryOptimal 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
Reported as:
Number · mg/kg
Optimal Dose of Atezolizumab in Pediatric Adult Participants
mg/kg<18 Age (Years)
Optimal Dose of Atezolizumab in Pediatric Adult Participants15
SecondaryOptimal 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
Reported as:
Number · mg
Optimal Dose of Atezolizumab in Young Adult Participants
mg>=18 Age (Years)
Optimal Dose of Atezolizumab in Young Adult Participants1200

Adverse events

Collected over From baseline up to approximately 42 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
COHORT 16/11 (54.5%)4/11 (36.4%)11/11 (100%)
COHORT 25/9 (55.6%)3/9 (33.3%)8/9 (88.9%)
COHORT 37/11 (63.6%)2/11 (18.2%)11/11 (100%)
COHORT 42/3 (66.7%)0/3 (0%)3/3 (100%)
COHORT 59/10 (90%)3/10 (30%)10/10 (100%)
COHORT 68/10 (80%)6/10 (60%)10/10 (100%)
COHORT 79/10 (90%)3/10 (30%)10/10 (100%)
COHORT 89/10 (90%)5/10 (50%)10/10 (100%)
COHORT 93/4 (75%)2/4 (50%)4/4 (100%)
COHORT 104/4 (100%)3/4 (75%)3/4 (75%)
COHORT 112/2 (100%)1/2 (50%)2/2 (100%)
COHORT 123/3 (100%)1/3 (33.3%)2/3 (66.7%)
Most frequent serious events
Showing 10 of 46
Most frequent serious events
EventCOHORT 1COHORT 2COHORT 3COHORT 4COHORT 5COHORT 6COHORT 7COHORT 8COHORT 9COHORT 10COHORT 11COHORT 12
LUNG INFECTIONInfections and infestations0/110/90/110/30/100/100/100/100/40/41/20/3
HYDROCEPHALUSNervous system disorders0/110/90/110/30/100/100/100/100/40/40/21/3
PAPILLOEDEMAEye disorders0/110/90/110/30/100/100/100/100/41/40/20/3
UPPER GASTROINTESTINAL HAEMORRHAGEGastrointestinal disorders0/110/90/110/30/100/100/100/101/40/40/20/3
DIABETIC KETOACIDOSISMetabolism and nutrition disorders0/110/90/110/30/100/100/100/100/41/40/20/3
HEADACHENervous system disorders0/110/90/110/30/100/100/100/100/41/40/20/3
PARAESTHESIANervous system disorders0/110/90/110/30/100/100/100/100/41/40/20/3
VITH NERVE DISORDERNervous system disorders0/110/90/110/30/100/100/100/100/41/40/20/3
PLEURAL EFFUSIONRespiratory, thoracic and mediastinal disorders0/110/90/110/30/100/100/101/101/40/40/20/3
PNEUMOTHORAXRespiratory, thoracic and mediastinal disorders0/110/90/110/30/100/100/100/100/41/40/20/3
Most frequent other events
Showing 10 of 243
Most frequent other events
EventCOHORT 1COHORT 2COHORT 3COHORT 4COHORT 5COHORT 6COHORT 7COHORT 8COHORT 9COHORT 10COHORT 11COHORT 12
PYREXIAGeneral disorders3/113/94/112/32/108/105/104/101/41/40/20/3
CONSTIPATIONGastrointestinal disorders3/111/92/111/36/106/102/106/101/40/40/20/3
FATIGUEGeneral disorders2/112/93/110/34/106/103/106/101/42/40/21/3
ANAEMIABlood and lymphatic system disorders3/111/93/111/35/102/103/102/101/41/41/21/3
DECREASED APPETITEMetabolism and nutrition disorders4/111/92/110/32/102/101/104/101/40/41/20/3
HYPOKALAEMIAMetabolism and nutrition disorders1/110/91/110/31/102/100/100/100/42/40/20/3
NECK PAINMusculoskeletal and connective tissue disorders1/110/92/110/31/100/100/101/100/42/40/20/3
PAIN IN EXTREMITYMusculoskeletal and connective tissue disorders2/111/92/110/31/102/100/100/101/42/40/20/3
COUGHRespiratory, thoracic and mediastinal disorders3/114/92/111/31/105/100/101/102/41/41/21/3
DIZZINESSNervous system disorders0/110/90/110/30/102/100/100/102/40/40/20/3

Baseline characteristics

Age, Continuous
Age, Continuous(Years)COHORT 1COHORT 2COHORT 3COHORT 4COHORT 5COHORT 6COHORT 7COHORT 8COHORT 9COHORT 10COHORT 11COHORT 12Total
Mean13.6 ± 3.314.2 ± 3.012.8 ± 9.419.0 ± 6.614.5 ± 6.517.1 ± 4.113.0 ± 8.512.6 ± 6.814.8 ± 1.011.3 ± 0.50.5 ± 0.77.3 ± 4.613.5 ± 6.4
Sex: Female, Male
Sex: Female, Male(Participants)COHORT 1COHORT 2COHORT 3COHORT 4COHORT 5COHORT 6COHORT 7COHORT 8COHORT 9COHORT 10COHORT 11COHORT 12Total
Female56405446041140
Male63735664401247
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)COHORT 1COHORT 2COHORT 3COHORT 4COHORT 5COHORT 6COHORT 7COHORT 8COHORT 9COHORT 10COHORT 11COHORT 12Total
Hispanic or Latino21211231200116
Not Hispanic or Latino75725666232051
Unknown or Not Reported23204213010220
Race (NIH/OMB)
Race (NIH/OMB)(Participants)COHORT 1COHORT 2COHORT 3COHORT 4COHORT 5COHORT 6COHORT 7COHORT 8COHORT 9COHORT 10COHORT 11COHORT 12Total
American Indian or Alaska Native0000000000000
Asian0000010010013
Native Hawaiian or Other Pacific Islander0000000000000
Black or African American0011010111006
White85526685122050
More than one race1010000000002
Unknown or Not Reported24404224110226
08

Study locations

30 sites
  • Arkansas Children'S Hospital
    Little Rock, Arkansas 72202, United States
  • Stanford University/Lucile Packard Children's Hospital
    Palo Alto, California 94304, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
  • Alberta Children'S Hospital
    Calgary, Alberta T3B 6A8, Canada
  • Rigshospitalet; BØRNEUNGEKLINIKKEN, Ambulatoriet for kræft- og Blodsygdomme hos børn og unge
    København Ø, 2100, Denmark
  • Centre Léon Bérard, Institut d'Hémato-Oncologie Pédiatrique
    Lyon, 69373, France
  • Institut Curie, Oncologie Pédiatrique
    Paris, 75231, France
  • Institut Gustave Roussy; Service Pediatrique
    Villejuif, 94805, France
  • Klinik Johann Wolfgang von Goethe Uni
    Frankfurt, 60590, Germany
  • Schneider Children's Medical Center
    Petach-Tikva, 49100, Israel
  • Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica
    Roma, Lazio 00165, Italy
  • IRCCS Istituto Giannina Gaslini; Unità Operativa Oncologica Pediatrica
    Genova, Liguria 16147, Italy
  • Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica
    Milano, Lombardia 20133, Italy
  • Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
    Torino, Piemonte 10126, Italy
  • Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica
    Padova, Veneto 35128, Italy
  • Erasmus MC / location Sophia Kinderziekenhuis
    Rotterdam, 3015 GJ, Netherlands
  • Hospital Sant Joan De Deu
    Esplugues De Llobregas, Barcelona 08950, Spain
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Infantil Universitario Nino Jesus
    Madrid, 28009, Spain
  • Hospital Universitari i Politecnic La Fe de Valencia
    Valencia, 46026, Spain
  • Universitäts-Kinderspital; Abteilung für Onkologie
    Zürich, 8032, Switzerland
  • Birmingham Children's Hospital
    Birmingham, B4 6NH, United Kingdom
  • Bristol Royal Hospital For Children
    Bristol, BS2 8BJ, United Kingdom
  • Leeds General Infirmary; Paediatric Oncology & Haematology
    Leeds, LS1 3EX, United Kingdom
  • The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit
    Newcastle Upon Tyne, NE1 4LP, United Kingdom
  • Royal Marsden Hospital; Pediatric Unit
    Surrey, SM2 5PT, United Kingdom
09

References and documents

Publications

  • 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. PubMed 31780255 ↗
  • 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. PubMed 31753029 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 21, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02541604
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Sep 4, 2015
Start date
Nov 30, 2015
Primary completion
Jun 6, 2019
Completion
Jun 6, 2019
Results posted
Feb 25, 2020
Last update
Feb 25, 2020

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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