Study Stopped
Discontinued early due to enrollment challenges and changes in treatment standards
Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma
A Randomized, Open-Label, Multicenter Phase II Study of Ipilimumab Retreatment Versus Chemotherapy for Subjects With Advanced Melanoma Who Progressed After Initially Achieving Disease Control With Ipilimumab Therapy
2 other identifiers
interventional
31
5 countries
17
Brief Summary
The purpose of the study is to determine whether additional doses of ipilimumab have a positive effect on survival in the treatment of advanced melanoma that has progressed after successful initial treatment with ipilimumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2013
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2012
CompletedFirst Posted
Study publicly available on registry
October 18, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
November 30, 2015
CompletedNovember 30, 2015
September 1, 2015
1.3 years
October 12, 2012
September 17, 2015
October 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date)
From randomization to death or last known alive date, assessed up to 15.6 months
Secondary Outcomes (2)
Disease Control Rate (DCR)
Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease
Best Overall Response Rate (BORR)
Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease
Other Outcomes (1)
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)
From Day 1 of treatment to 90 days after last dose (or to death date for death information)
Study Arms (2)
Ipilimumab, 3 mg/kg
EXPERIMENTALParticipants received ipilimumab, 3 mg/kg, by intravenous infusion, every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
Chemotherapy
ACTIVE COMPARATORParticipants received the investigator's choice of chemotherapy, administered per package instructions.
Interventions
Eligibility Criteria
You may qualify if:
- Histologic diagnosis of unresectable stage III or IV metastatic melanoma
- Prior ipilimumab induction treatment (3 mg/kg)
- Documented disease control \[Stable Disease ≥3 months or Partial Response/Complete Response\] after ipilimumab induction
- Documented progressive disease following disease control
You may not qualify if:
- Patients with brain metastasis are excluded, unless they are free of neurologic symptoms related to metastatic brain lesions and do not receive systemic corticosteroid therapy for the purpose of reducing intracranial inflammation in the 10 days prior to beginning retreatment with ipilimumab
- Any intervening anticancer therapy between last dose of ipilimumab induction and ipilimumab retreatment on study
- Patients who experienced any grade 3 immune-related adverse event (irAE) (except for endocrinopathies where clinical symptoms were controlled with appropriate hormone replacement therapy) or any grade 4 toxicity during prior treatment with ipilimumab
- Patients with a prior irAE that has not improved to grade 1 or better at randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Birmingham Hematology & Oncology Associates Llc
Birmingham, Alabama, 35205, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012, United States
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, 46260, United States
Cancer Center Of Kansas
Wichita, Kansas, 67214, United States
Comprehensive Cancer Center Of Nevada
Las Vegas, Nevada, 89148, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Texas Oncology Sammons Cancer Center
Dallas, Texas, 75246, United States
Local Institution
Vienna, A-1090, Austria
Local Institution
Bordeaux, 33075, France
Local Institution
Nantes, 44093, France
Local Institution
Paris, 75010, France
Local Institution
Cologne, 50937, Germany
Local Institution
Erfurt, 99089, Germany
Local Institution
Göttingen, 37075, Germany
Local Institution
Heidelberg, 69115, Germany
Local Institution
Kiel, 24105, Germany
Local Institution
Siena, 53100, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
As planned, accrual of participants was to be completed within 21 months. However, current projections showed that 4 to 5 years were needed. The study was terminated early because the scientific objective could not be met in the predefined timeframe.
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2012
First Posted
October 18, 2012
Study Start
March 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
November 30, 2015
Results First Posted
November 30, 2015
Record last verified: 2015-09