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SBRT as a Vaccination for Metastatic Melanoma

NCT04042506 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-04-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]

480mg IV every 4 weeks

RADIATION

Stereotactic Body Radiation Therapy (SBRT)

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.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Daniel Song, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-26
Primary Completion
2019-11-26
Completion
2021-01-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04042506 on ClinicalTrials.gov