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Pilot Ipilimumab in Stage IV Melanoma Receiving Palliative Radiation Therapy

NCT01449279 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-03-02

Study results available
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Summary

To determine the safety of local palliative radiation therapy used in combination with anti-CTLA-4 immunotherapy.

Conditions

Interventions

DRUG

Ipilimumab

Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.

RADIATION

Radiation Therapy

Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist.

Sponsors & Collaborators

Principal Investigators

  • Susan J Knox, PhD, MD · Stanford 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
2011-10-31
Primary Completion
2015-12-31
Completion
2016-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01449279 on ClinicalTrials.gov