Brief Summary

To assess the response of melanoma with brain metastases to ipilimumab treatment while maintaining acceptable tolerability.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jul 2008

Typical duration for phase_2

Geographic Reach

1 country

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.3 years study duration

First Submitted

Initial submission to the registry

February 19, 2008

Completed

7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed

4 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed

3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

June 9, 2014

Completed

Last Updated

June 9, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

February 19, 2008

Results QC Date

December 17, 2013

Last Update Submit

May 27, 2014

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

Disease Control Rate by Modified World Health Organization (mWHO) Tumor Assessment Criteria
Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (global, in brain, or outside of brain) based on mWHO criteria divided by the number of patients who received treatment. By mWHO criteria: CR=complete disappearance of all index lesions. PR=decrease, relative to baseline, of 50% or greater in the sum of the 2 largest perpendicular diameters of all index lesions. SD=does not meet criteria for CR or PR, in the absence of progressive disease (PD). Patients with PR or CR not confirmed after at least 4 weeks are scored as SD unless they have new primary lesions. PD=at least 25% increase in the sum of the diameters of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesions. CNS=central nervous system.
From Day 1, first dose to end of Week 12

Secondary Outcomes (8)

Disease Control Rate by Immune-related Response Criteria (irRC)
From Day 1, first dose to end of Week 12
Best Overall Response Rate (BORR) by Modified World Health Organization (mWHO) Criteria and by Immune-relate Response Criteria (irRC)
From Day 1, first dose until the last tumor assessment, Week 12
Duration of Response (DOR) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
From Day 1, first dose to last tumor assessment up to 18.2 months
Progression-free Survival (PFS) by Modified World Health Organization (mWHO) Criteria and by Immune-related Response Criteria (irRC)
From Day 1, first dose to the date of progression or death, whichever occurred first up to 22 months
Number of Participants Surviving at 6, 12, 18, 24, and 36 Months (Overall Survival [OS] Rate)
From first dose to Months 6, 12, 18, 24, and 36 months
+3 more secondary outcomes

Study Arms (2)

Ipilimumab, 10 mg/kg, IV in corticosteroid-free patients

EXPERIMENTAL

Participants who had not received corticosteroid therapy for at least 10 days before starting study drug received ipilimumab,10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24.

Drug: Ipilimumab

Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patients

EXPERIMENTAL

Participants who were dependent on corticosteroid therapy received ipilimumab, 10 mg/kg, as a 90-minute intravenous (IV) infusion every 3 weeks (Weeks 1, 4, 7, and 10) during the Induction Phase. Those eligible (patients who did not discontinue due to toxicity, did not show progression at 24 weeks, and who remained clinically stable) for the Maintenance Phase continued to receive ipilimumab, 10 mg/kg IV, every 12 weeks, beginning at Week 24.

Drug: IpilimumabDrug: Corticosteroid: BetamethasoneDrug: Corticosteroid: DexamethasoneDrug: Corticosteroid: FludrocortisoneDrug: Corticosteroid: HydrocortisoneDrug: Corticosteroid: MeprednisoneDrug: Corticosteroid: MethylprednisoloneDrug: Corticosteroid: PrednisoloneDrug: Corticosteroid: PrednisoneDrug: Corticosteroid: Triamcinolone

Interventions

IpilimumabDRUG

10 mg/kg, administered as an intravenous infusion every 3 weeks during induction and every 12 weeks during maintenance

Also known as: BMS-734016, MDX-010

Ipilimumab, 10 mg/kg, IV in corticosteroid-dependent patientsIpilimumab, 10 mg/kg, IV in corticosteroid-free patients

Corticosteroid: BetamethasoneDRUG

Participants in the corticosteroid-dependent arm for whom adequate control of metastatic brain lesion-related neurologic signs and symptoms required concurrent corticosteroid therapy with betamethasone