Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT02858869
Phase
PHASE1
Status
Completed

Conditions

  • Melanoma of Unknown Primary
  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Melanoma
  • Mucosal Melanoma
  • Ocular Melanoma
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IV Skin Melanoma

Eligibility Criteria

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

Interventions

  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Stereotactic Radiosurgery — RADIATION
    Undergo SRS

Study Details

This pilot trial studies the side effects of giving pembrolizumab together with stereotactic radiosurgery to treat patients with melanoma or non-small cell lung cancer that has spread to the brain. Monoclonal antibodies, such as pembrolizumab, 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. Giving pembrolizumab together with stereotactic radiosurgery may be a better treatment for patients with melanoma or non-small cell lung cancer that has spread to the brain.

Key Dates

Start date
Oct 4, 2016
Status verified
Feb 2026
Primary completion
Nov 19, 2020
Completion
Oct 28, 2023

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (pembrolizumab, SRS 6 Gy, CLOSED):
    Patients receive 200 mg pembrolizumab IV over 30 minutes on day 1. Courses repeat Q3W for at least 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo 5 SRS fractions between days 2-15 of course 1.
  • Experimental: Arm B (pembrolizumab, SRS 9 Gy)
    Patients receive pembrolizumab IV as in Arm A. Patients undergo 3 SRS fractions between days 2-15 of course 1.
  • Experimental: Arm C (pembrolizumab, SRS 18-21 Gy)
    Patients receive pembrolizumab IV as in Arm A. Patients undergo 1 SRS fraction between days 2-3 of course 1.

Primary Outcome Measure

Dose Limiting Toxicities [ Time Frame: 3 months after first pembrolizumab dose ]

Locations (1)

FacilityCityStateZIP
Emory University/Winship Cancer InstituteAtlantaGeorgia30322

Related coverage on Hipa.ai

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By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Emory University/Winship Cancer Institute· Atlanta, GA

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