SBRT as a Vaccination for Metastatic Melanoma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT04042506
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] — DRUG
    480mg IV every 4 weeks
  • Stereotactic Body Radiation Therapy (SBRT) — RADIATION
    SBRT dose of 8-10 Gy x 3 fractions (at maximum 3 doses per week) delivered to 1 extracranial site between days 1-14 of Cycle 1.

Study Details

Immunotherapy with PD-1 blockade is a first-line treatment for patients with advanced melanoma, but unfortunately most patients progress on this therapy. Recent evidence suggests that radiation can enhance the immune response in the presence of checkpoint blockade. The investigators aim to determine if radiation can elicit increased immune responses in patients who have stable or progressive disease on nivolumab.

Key Dates

Start date
Nov 26, 2019
Status verified
Apr 2020
Primary completion
Nov 26, 2019
Completion
Jan 26, 2021

Study Design

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

Arms

  • Experimental: Extracranial SBRT and Nivolumab
    Stereotactic body radiation therapy (SBRT) will be given to a single extracranial metastatic site in combination with nivolumab. Patients will receive nivolumab 480mg intravenously (IV) every 4 weeks (1 cycle = 8 weeks), as well as SBRT dose of 8-10 Gy x 3 fractions (at maximum 3 doses per week) delivered to 1 extracranial site between days 1-14 of Cycle 1. Nivolumab will be continued until confirmed progression, unacceptable toxicity, or total of 6 Cycles (whichever occurs first).

Primary Outcome Measure

Safety of SBRT in the presence of immune checkpoint blockade (ICB) as measured by number of participants experiencing adverse events [ Time Frame: 12 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins BayviewBaltimoreMaryland21224-
The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins UniversityBaltimoreMaryland21231-

Find similar trials in Baltimore, MD

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Johns Hopkins Bayview· Baltimore, MDThe Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins University· Baltimore, MD

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