CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
Sylatron +1 moredrug
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/NCT01496807
NCT01496807Phase 1Completed
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A Phase Ib Study of Yervoy With Sylatron for Patients With Unresectable Stages IIIB/C/IV Melanoma

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Dec 21, 2011·Updated Apr 28, 2017

In Brief

A Phase 1 clinical trial evaluating Sylatron and Yervoy for Melanoma. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The purpose of this study is to see how much of the drug Yervoy can be safely tolerated when it is given to people who are also receiving a drug called Sylatron. Investigators also wish to find out whether the addition of Yervoy increases the chance that Sylatron will cause a rise in the level of antibodies in the patient's blood that recognize their own tissues, known as "autoimmune" antibodies. Investigators also want to find out how likely it is that their tumor will shrink.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2011
Enrollment StartFeb 17, 2012
Primary CompletionMar 16, 2016
Study CompletionAug 29, 2016
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 14.5 years ago

Interventions

Sylatrondrug

Sylatron - Once per week for 12 weeks, given as an injection under the skin.

Yervoydrug

Yervoy - Once every 3 weeks for 12 weeks (4 times total), given over a 90-minute intravenous infusion (through the vein).