A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide

Part of paid clinical trials in Los Angeles, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT00135408
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab+ Placebo — DRUG
    Solution, Intravenous, 10 mg/kg, 3 weeks, 12 - 48 weeks depending on the response.
  • Ipilimumab+ Budesonide — DRUG
    Solution/Capsule, Intravenous/Oral, 10 mg/kg + 9 mg, 3 weeks (Ipilimumab) + once daily until week 16 (Budesonide), 12 - 48 weeks depending on the response.

Study Details

The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.

Key Dates

Start date
Dec 31, 2005
Status verified
Sep 2016
Primary completion
Jul 31, 2007
Completion
Jul 31, 2007

Study Design

Enrollment
115 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: A1
  • Active Comparator: A2

Primary Outcome Measure

Rate of Grade 2,3,4 Diarrhea - patients on study drug.

Locations (4)

FacilityCityStateZIPSite coordinators
-Los AngelesCalifornia--
-San FranciscoCalifornia--
-CharlotteNorth Carolina--
-SeattleWashington--

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