NCT02989636

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

Phase I Safety Study of Stereotactic Radiosurgery With Concurrent and Adjuvant PD-1 Antibody Nivolumab in Subjects With Recurrent or Advanced Chordoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chordoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Nivolumab	Given IV
RADIATION	Stereotactic Radiosurgery	Undergo SRS

Timeline

• Start date: 2017-03-10
• Primary completion: 2024-04-24
• Completion: 2026-11-01
• First posted: 2016-12-12
• Last updated: 2026-01-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study