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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Melanoma

Treatments: Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162123

CA184-025

Details and patient eligibility

About

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.

Enrollment: 248 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria

• Diagnosis of advanced melanoma
• Prior treatment in a prespecified prior/parent ipilimumab study
• Men and women 18 years of age and older

First Reinduction:

• No unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation
• Had experienced documented progressive disease after expanded clinical benefit

Extended Maintenance

• Received ipilimumab at any dose in a parent study
• Achieved expanded clinical benefit at the time of entry to current study

Follow-up:

• Received ipilimumab at any dose in a closing parent study
• Deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up

Key Exclusion Criteria

• Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab
• Primary ocular or mucosal melanoma

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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248 participants in 7 patient groups

First reinduction: Ipilimumab, 0.3 to 10 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Ipilimumab

First reinduction: Ipilimumab, 3 to 10 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Ipilimumab

First reinduction: Ipilimumab, 10 to 10 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Ipilimumab

Extended maintenance: Ipilimumab, 0.3 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Ipilimumab

Extended maintenance: Ipilimumab, 3 mg/kg

Experimental group

Description:

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.

Treatment:

Drug: Ipilimumab

Extended maintenance: Ipilimumab, 10 mg

Experimental group

Description:

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.

Treatment:

Drug: Ipilimumab

Follow-up

No Intervention group

Description:

Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.