CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
ipilimumab +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02107755
NCT02107755Phase 2Completed

A Phase 2 Study Using Stereotactic Ablative Radiation Therapy and Ipilimumab in Patients With Oligometastatic Melanoma

Ohio State University Comprehensive Cancer Center·interventional·Posted Apr 8, 2014·Updated May 21, 2024

In Brief

A Phase 2 clinical trial evaluating ipilimumab, stereotactic radiosurgery, and 1 other intervention for Liver Metastases and 4 related conditions. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 8, 2014
Enrollment StartSep 5, 2014
Primary CompletionAug 3, 2020
Study CompletionAug 16, 2021
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 12.2 years ago

Interventions

ipilimumabbiological

Given IV

stereotactic radiosurgeryradiation

Undergo stereotactic radiosurgery

laboratory biomarker analysisother

Blood and tissue samples will be collected for research purposes.