SRS and Nivolumab in Treating Patients With Newly Diagnosed Melanoma Metastases in the Brain or Spine

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT02716948
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Malignant Neoplasm in the Spine
  • Stage IV Skin Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV
  • Stereotactic Radiosurgery — RADIATION
    Undergo stereotactic radiosurgery

Study Details

This phase I pilot trial studies the side effects of stereotactic radiosurgery and nivolumab in treating patients with newly diagnosed melanoma that has spread to the brain or spine. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor to more precisely target the cancer. Monoclonal antibodies, such as nivolumab may interfere with the ability of tumor cells to grow and spread. Giving stereotactic radiosurgery together with nivolumab may be a better treatment for melanoma.

Key Dates

Start date
Jun 23, 2016
Status verified
Nov 2021
Primary completion
Aug 27, 2021
Completion
Aug 27, 2021

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab, stereotactic radiosurgery)
    Patients receive nivolumab IV over 60 minutes on day 1. Patients then undergo stereotactic radiosurgery on day 8 per standard of care. Courses with nivolumab repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of serious adverse events (SAE) graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 4.0 [ Time Frame: Up 12 weeks after first dose of study treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MD

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