Trial Search Results

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

The study is an early-phase, multicenter, open-label, single-arm study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of atezolizumab in pediatric and young adult patients with solid tumors with known or expected PD-L1 pathway involvement for which prior treatment has proven to be ineffective (i.e., relapsed or refractory) or intolerable and for whom no curative standard-of-care treatment options exist.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Stanford Investigator(s):

Intervention(s):

  • Drug: Atezolizumab

Phase:

Phase 1/Phase 2

Eligibility


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 FluMistĀ®) 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

Ages Eligible for Study

N/A - 30 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting