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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02107755
Other study ID # OSU-12182
Secondary ID NCI-2014-00381
Status Completed
Phase Phase 2
First received
Last updated
Start date September 5, 2014
Est. completion date August 16, 2021

Study information

Verified date April 2024
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Biological:
ipilimumab
Given IV
Radiation:
stereotactic radiosurgery
Undergo stereotactic radiosurgery
Other:
laboratory biomarker analysis
Blood and tissue samples will be collected for research purposes.

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Marker Levels Between Those With vs. Without the Clinical Improvement Summarized univariately in a quantitative manner and also summarized by clinical outcome group (e.g. prog-free and alive at 6 months vs. not). Graphical analyses will be largely used to assess potential patterns and relationships; e.g. side-by-side boxplots to assess differences. Baseline to week 50
Primary Rate of Progression-free Survival by mWHO Criteria Calculated along with corresponding 95% binomial confidence intervals. Kaplan-Meier curves will be used. Time of study enrollment until the first documented date of disease progression, assessed up to 6 months
Secondary Rate of Progression-free Survival by irRC Criteria Calculated along with corresponding 95% binomial confidence intervals. Kaplan-Meier curves will be used. Time of study enrollment until the first documented date of disease progression, assessed up to 6 months
Secondary Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4 Frequency and severity of adverse events and tolerability of the regimen in each of the patient groups will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. Up to 90 days after the last ipilimumab infusion
Secondary Frequency of Objective Response Rate, Defined as Complete Response + Partial Response, Measured by Computed Tomography (CT) Using mWHO Criteria The response rate evaluated based on mWHO & irRC criteria Up to 12 weeks
Secondary Frequency of Objective Response Rate, Defined Using irRC Up to 12 weeks
Secondary Rate of Local Failure Time of study enrollment until the first documented date of failure within the irradiated field, assessed up to 10 years
Secondary Rate of Overall Survival Kaplan-Meier curves will be used. Time of study enrollment until the time of death, assessed up to 6 years
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