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

Recruiting in Palo Alto (17 mi)

+55 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bristol-Myers Squibb

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

Prior treatment in a prespecified prior/parent ipilimumab study

Men and women 18 years of age and older

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

See 7 more

Treatment Details

Interventions

Ipilimumab (Checkpoint Inhibitor)

Participant Groups

7Treatment groups

Experimental Treatment

Active Control

Group I: First reinduction: Ipilimumab, 3 to 10 mg/kgExperimental Treatment1 Intervention

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.

Group II: First reinduction: Ipilimumab, 10 to 10 mg/kgExperimental Treatment1 Intervention

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.

Group III: First reinduction: Ipilimumab, 0.3 to 10 mg/kgExperimental Treatment1 Intervention

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.

Group IV: Extended maintenance: Ipilimumab, 3 mg/kgExperimental Treatment1 Intervention

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.

Group V: Extended maintenance: Ipilimumab, 10 mgExperimental Treatment1 Intervention

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.

Group VI: Extended maintenance: Ipilimumab, 0.3 mg/kgExperimental Treatment1 Intervention

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.

Group VII: Follow-upActive Control1 Intervention

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