Nivolumab With or Without Stereotactic Radiosurgery in Treating Patients

Status Active, not recruiting

Clinical Trial Summary

This phase I trial studies the side effects of nivolumab with or without stereotactic radiosurgery (SRS) in treating patients with chordoma that has come back or spread from where it started to other places in the body. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. It is not yet known whether giving nivolumab with or without stereotactic radiosurgery may work better in treating patients with chordoma.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To assess the safety profile of nivolumab alone and nivolumab in combination with stereotactic radiosurgery to treat patients with recurrent or advanced chordoma. SECONDARY OBJECTIVES: I. To evaluate toxicity and tolerability of nivolumab alone and nivolumab in combination with stereotactic radiosurgery. II. To estimate growth modulation index on target lesion. III. To estimate a clinical response (partial response [PR] + complete response [CR] within 6 month + stable disease [SD] beyond 6 months). IV. To assess progression-free survival and progression-free survival (PFS) rate at 6 months. V. To assess overall survival rate at 1 year, 3 years and 5 years. TERTIARY OBJECTIVES: I. To explore peripheral blood immune response during and after treatment. OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1. Courses repeat every 14 days for 2 years in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive nivolumab as in Arm I. Patients undergo stereotactic radiosurgery (SRS) as per standard of care on day 8 of course 1. After completion of study treatment, patients are followed up at 100 days and every 10 weeks thereafter. ;

Study Design

Related Conditions & MeSH terms

Chordoma

Clinical Trial Details

NCT number	NCT02989636
Study type	Interventional
Source	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	March 10, 2017
Completion date	November 2024

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Nivolumab With or Without Stereotactic Radiosurgery in Treating Patients With Recurrent, Advanced, or Metastatic Chordoma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms