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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Hoffmann-La Roche
Study ID
NCT02541604
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 30, 2015
Status verified
Feb 2020
Primary completion
Jun 6, 2019
Completion
Jun 6, 2019

Study Design

Enrollment
87 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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 42 months) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Arkansas Children'S HospitalLittle RockArkansas72202-
Stanford University/Lucile Packard Children's HospitalPalo AltoCalifornia94304-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033-
MD Anderson Cancer CenterHoustonTexas77030-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-

Find similar trials in Little Rock, AR

By research site
Arkansas Children'S Hospital· Little Rock, ARStanford University/Lucile Packard Children's Hospital· Palo Alto, CADana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYPenn State Milton S. Hershey Medical Center· Hershey, PAMD Anderson Cancer Center· Houston, TX

Related Studies