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Completed

NCT Number: NCT00162123

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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ipilimumab

Drug

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

Primary outcomes

  1. 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.

    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 outcomes

  1. Overall Survival (OS)

    Time frame: From first dose of study drug in parent study to death or date of last censoring.

    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.

  2. 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

    Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.

  3. 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

    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.

  4. Progression-free Survival (PFS)

    Time frame: From day of first reinduction in current study to date of progression or death, whichever occurred first.

    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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2012
Study completion
2014
First posted
Sep 13, 2005
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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