Compassionate Use Trial for Unresectable Melanoma With Ipilimumab

NCT00495066 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2013-06-03

No results posted yet for this study

Summary

The primary objective of the study is to provide treatment with Ipilimumab to subjects who have serious or immediately life-threatening unresectable Stage III or Stage IV melanoma, who have no alternative treatment options, and whose physicians believe, based upon available data on benefit and risk, that it is appropriate to administer Ipilimumab at a dose of 3 mg/kg induction (with re-induction, if eligible), or for eligible subjects previously enrolled in Ipilimumab studies CA184-042, CA184-078, CA184-087, MDX010-16, or MDX010-20.

Conditions

Interventions

DRUG

Ipilimumab

Intravenous Solution, Intravenous, Ipilimumab 3 mg/kg, Ipilimumab - one dose every 3 wks for a total of 4 doses. Subjects who are eligible may receive another 4 doses given every 3 wks; Until disease progression, unacceptable toxicity or withdrawal of consent

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Brazil

Study Locations

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Entities

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 NCT00495066 on ClinicalTrials.gov