Stereotactic Radiosurgery and Immune Checkpoint Inhibitors With NovoTTF-200M for the Treatment of Melanoma Brain Metastases

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05341349
Phase
PHASE1
Status
Terminated

Conditions

  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Melanoma of Unknown Primary
  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Melanoma
  • Metastatic Mucosal Melanoma
  • Metastatic Ocular Melanoma
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8

Eligibility Criteria

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

Interventions

  • Ipilimumab — BIOLOGICAL
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Stereotactic Radiosurgery — RADIATION
    Undergo SRS
  • Tumor Treating Fields Therapy — PROCEDURE
    Undergo TTFields

Study Details

This phase I trial finds out the side effects and possible benefits of stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-100M for the treating of melanoma that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. It is used to treat brain tumors and other brain disorders that cannot be treated by regular surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. NovoTTF-100M is a portable battery operated device which produces tumor treating fields in the body by means of surface electrodes placed on the skin. Tumor treating fields are low intensity, intermediate frequency electric fields that pulse through the skin to disrupt cancer cells' ability to divide. Giving stereotactic radiosurgery and immune checkpoint inhibitors with NovoTTF-100M may work better than stereotactic radiosurgery and immune checkpoint inhibitors.

Key Dates

Start date
Oct 13, 2022
Status verified
Apr 2026
Primary completion
May 31, 2024
Completion
May 31, 2024

Study Design

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

Arms

  • Experimental: Arm I (SRS, pembrolizumab, TTFields)
    Patients receive standard of care pembrolizumab and undergo 3-5 fractions SRS. Patients also undergo TTFields over 8 hours daily using NovoTTF-100M device until intra-cranial progression or until end of immunotherapy treatments at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (nivolumab, ipilimumab, SRS, TTFields)
    Patients receive standard of care nivolumab and ipilimumab and undergo 3-5 fractions SRS. Patients also undergo TTFields over 8 hours daily using NovoTTF-100M device until intra-cranial progression or until end of immunotherapy treatments at the discretion of the treating physician in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

The percentage of patients developing grade 3 CNS toxicity [ Time Frame: At 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

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

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