A Single-Arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of MPDL3280A (Anti-PD-L1 Antibody) in Pediatric and Young Adult Participants With Solid Tumors

Status: Recruiting
Phase:
DFCI Protocol ID: 15-308

This early phase, multicenter, open-label, single-arm study will evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of MPDL3280A in pediatric and young adult patients with solid tumors for which prior treatment was proven to be ineffective.

Conducting Institutions:

Children's Hospital Boston, Dana-Farber Cancer Institute

Overall PI:

Steven Dubois MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Mark Morley, mmorley@partners.org
Dana-Farber Cancer Institute: Melissa Hohos, mhohos@partners.org

Eligibility Criteria

Inclusion Criteria:

  -  Age at study entry less than (<) 30 years

  -  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

  -  Current disease state for which there is no known curative therapy or therapy proven
     to prolong survival with an acceptable quality of life

  -  Disease that is measurable as defined by International Neuroblastoma Response
     Criteria (INRC), Revised Response Criteria for Malignant Lymphoma, Response
     Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (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 <16 years old) or Karnofsky Performance
     Status (participants >=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, untreated CNS metastases, or
     treated but symptomatic CNS metastases

  -  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 4 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 6 weeks prior to
     initiation of study drug

  -  Treatment with hormonal therapy (except hormone replacement therapy or oral
     contraceptives), immunotherapy, biologic therapy, or herbal cancer therapy within 4
     weeks prior to initiation of study drug

  -  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 within 4 weeks prior to
     initiation of study drug or anticipation that such treatment will be required during
     the study or within 100 days after the final dose of study drug

  -  Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
     including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA4), anti-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) within 2 weeks prior to initiation of study drug, or anticipated
     requirement for systemic immunosuppressive medications during the trial

  -  Current treatment with therapeutic anticoagulants

  -  Any non-hematologic toxicity (excluding alopecia) from prior treatment that has not
     resolved to Grade <=1 (per National Cancer Institute Common Terminology Criteria for
     Adverse Events [NCI CTCAE] version 4.0) at screening

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