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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00162123
First received: September 9, 2005
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Melanoma
Drug: Ipilimumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From first dose of study drug in parent study to death or date of last censoring. ] [ Designated as safety issue: No ]
    OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.

  • Percentage of Participants Surviving at 1, 1.5, and 2 Years [ Time Frame: From first dose of study drug in parent study to up to 2 years after reinduction ] [ Designated as safety issue: No ]
    Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.

  • Number of Participants With On-study Immune-related Adverse Events (irAEs) [ Time Frame: From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date ] [ Designated as safety issue: Yes ]
    irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.

  • Progression-free Survival (PFS) [ Time Frame: From day of first reinduction in current study to date of progression or death, whichever occurred first. ] [ Designated as safety issue: No ]
    PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.


Enrollment: 248
Study Start Date: May 2006
Study Completion Date: April 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Other Names:
  • BMS-734016
  • MDX-010
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.
Drug: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Other Names:
  • BMS-734016
  • MDX-010
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.
Drug: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Other Names:
  • BMS-734016
  • MDX-010
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.
Drug: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Other Names:
  • BMS-734016
  • MDX-010
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.
Drug: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Other Names:
  • BMS-734016
  • MDX-010
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.
Drug: Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Other Names:
  • BMS-734016
  • MDX-010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162123

  Show 58 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00162123     History of Changes
Other Study ID Numbers: CA184-025
Study First Received: September 9, 2005
Results First Received: December 31, 2013
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
ipilimumab
previously treated

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 26, 2014