A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

Conditions

• Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ipilimumab — DRUG
  Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation

Study Details

The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.

Key Dates

Start date

May 31, 2006

Status verified

Jun 2016

Primary completion

Sep 30, 2012

Completion

Apr 30, 2014

Study Design

Enrollment

248 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: First reinduction: Ipilimumab, 0.3 to 10 mg/kg
  Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
• Experimental: First reinduction: Ipilimumab, 3 to 10 mg/kg
  Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
• Experimental: First reinduction: Ipilimumab, 10 to 10 mg/kg
  Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
• Experimental: Extended maintenance: Ipilimumab, 0.3 mg/kg
  Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
• Experimental: Extended maintenance: Ipilimumab, 3 mg/kg
  Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
• Experimental: Extended maintenance: Ipilimumab, 10 mg
  Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
• No Intervention: Follow-up
  Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.

Primary Outcome Measure

Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome [ Time Frame: Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug. ]

Locations (19)

Find similar trials in Tucson, AZ

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