OSTPDL1: A Phase II Trial of Avelumab for Patients with Recurrent or Progressive Osteosarcoma

A Phase II Trial of Avelumab, a Fully Humanized Antibody that Targets Cells Expressing PD-L1 in Patients with Recurrent or Progressive Osteosarcoma

Category:

Solid Tumor

Diseases Treated:

Osteosarcoma

Eligibility Overview:

  • At least 12 years old and younger than 25 years old
  • Osteosarcoma that has relapsed, progressed or become refractory to conventional therapy
  1. Brief Summary

    Patients with recurrent or progressive osteosarcoma have a poor overall survival rate and are unlikely to achieve cure without complete surgical remission. However, immunotherapy with checkpoint inhibitors has demonstrated dramatic changes in outcomes in several adult cancers, including melanoma, Hodgkin lymphoma, renal cell carcinoma and non-small cell lung cancer. Studies suggest this approach may also be useful against tumors with a high mutational load, such as osteosarcoma.

    This Phase II study will assess the efficacy of avelumab, an experimental monoclonal antibody directed against the PD-L1 protein in patients with recurrent or progressive osteosarcoma. High levels of PD-L1 expression have been found to be associated with disease progression, increased metastasis, poor response to treatment and decreased survival in multiple cancers. Inhibiting PD-L1 results in the restoration of cytotoxic T cell response and elimination of tumor cells.

    Primary Objectives

    • To estimate the response rate to 4 cycles of avelumab in patients with recurrent or progressive osteosarcoma
    • To estimate the 16-week progression-free survival of patients after treatment with avelumab

    Eligibility Criteria

    Inclusion criteria include:

    • At least 12 years old and younger than 25 years old
    • Osteosarcoma that has relapsed, progressed or become refractory to conventional therapy
    • Performance status of ≥ 50 using the Karnofsky scale for patients older than 16 years
    • Performance status of ≥ 50 using the Lansky scale for patients age 16 and younger
    • Fully recovered from acute toxic effects of prior chemotherapy, immunotherapy or radiotherapy

    Exclusion Criteria include:

    • Central nervous system metastases
    • Current use of immunosuppressive medication, except for the following:
      • Intranasal, inhaled, topical steroids or local steroid injection
      • Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent
      • Steroids as premedication for hypersensitivity reactions
    • HIV-positive
    • Hepatitis B or C infection
    • Pregnant or actively breastfeeding

    Study Design

    Single Arm, Phase II

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

    Collaborating sites in and outside the U.S.

  2. About this study

    Osteosarcoma is the most common bone cancer in children and teenagers. Most patients get better after treatment with strong anti-cancer medicine, also known as chemotherapy, and surgery. However, some patients do not get better with treatment, or their cancer comes back after therapy.

    Avelumab is a type of drug called a monoclonal antibody. Monoclonal antibodies are drugs made in the laboratory. They latch onto cancer cells and other substances in the body. Avelumab grabs onto a protein often found in cancer cells. This protein is called PD-L1. Avelumab blocks PD-L1, clearing a path for the body’s immune system to fight the cancer cells.

    Avelumab is an experimental drug. This means it has not been approved by the U.S. Food and Drug Administration for osteosarcoma or any other disease. Avelumab has been tested in adults with some other cancers. These studies suggest the drug may help the body fight cancer cells when combined with other therapies.

    Purpose of this clinical trial

    The main goal of this study is to see how well avelumab works in patients with osteosarcoma that has come back after treatment or not responded to treatment. Researchers want to find out the good and bad effects of avelumab.

    Eligibility overview

    • At least 12 years old and younger than 25 years old
    • Osteosarcoma that has relapsed, progressed or become refractory to conventional therapy
  3. OSTPDL1 Quick View
    Sponsors St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT03006848
    Trial Start Date January 2017
    Estimated Enrollment 40 (20 at St. Jude)
    Study Type Interventional
    Study Phase Phase II
    Conditions Osteosarcoma
    Ages At least 12 years old and younger than 25 years old
    Principal investigator Michael Bishop, MD
    Study Sites St. Jude Children’s Research Hospital and collaborating sites in and outside the U.S.
    For a consultation or to discuss OSTPDL1 St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Michael Bishop, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.