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Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma

NCT02107755 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-05-21

Study results available
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Summary

This phase II trial studies the effectiveness of the combination of stereotactic radiation therapy and ipilimumab in patients with metastatic melanoma that has spread to four or fewer sites in the body (oligometastatic). Stereotactic radiation therapy is a type of external beam radiation therapy that uses special equipment to position the patient and precisely give a either a single large dose of radiation therapy to a tumor or several large doses of radiation therapy to a tumor using precision and accuracy that is guided by onboard daily imaging prior to radiation therapy. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some monoclonal antibodies find tumor cells and help kill them or carry tumor-killing substances to them. Giving stereotactic radiosurgery together with ipilimumab may kill more tumor cells by causing addition melanoma antigens to be presented to the immune system.

Conditions

  • Liver Metastases
  • Lung Metastases
  • Recurrent Melanoma
  • Stage IV Melanoma
  • Tumors Metastatic to Brain

Interventions

BIOLOGICAL

ipilimumab

Given IV

RADIATION

stereotactic radiosurgery

Undergo stereotactic radiosurgery

OTHER

laboratory biomarker analysis

Blood and tissue samples will be collected for research purposes.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jose Bazan, MD · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-05
Primary Completion
2020-08-03
Completion
2021-08-16
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02107755 on ClinicalTrials.gov