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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma

Thank you

Trial Information

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


Minimum age of participants is 18 years (or 16 years, if allowable per local regulatory
authority)


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:



- Histological diagnosis of unresectable stage III or IV metastatic melanoma

- Prior Ipilimumab induction treatment (3mg/kg)

- Documented disease control [Stable Disease (SD) ≥ 3 months or PR/CR] after Ipilimumab
induction

- Documented progressive disease following disease control

Exclusion Criteria:

- Subjects 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

- Subjects who experienced any grade 3 immune-related adverse events (irAE) (except for
endocrinopathies where clinical symptoms were controlled with appropriate hormone
replacement therapy) or any grade 4 toxicity during prior treatment with Ipilimumab

- Subjects with a prior irAE that has not improved to grade 1 or better at
randomization

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival rate

Outcome Description:

The survival rate at 18 months is defined as the proportion of subjects still alive at 18 months or more from randomization divided by the total number of subjects randomized. Vital status will be assessed at each study visit. Analysis of overall survival rate will be done at 18 months from LPFV

Outcome Time Frame:

At 18 months from Last Patient First Visit (LPFV)

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

CA184-243

NCT ID:

NCT01709162

Start Date:

March 2013

Completion Date:

January 2020

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

Lehigh Valley HospitalAllentown, Pennsylvania  18103
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
The Angeles Clinic & Research InstituteLos Angeles, California  90404
Local InstitutionIndianapolis, Indiana  
Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio  
Local InstitutionBirmingham, Alabama  
Local InstitutionCorona, California  
Local InstitutionAurora, Colorado  
Local InstitutionFort Lauderdale, Florida  
Local InstitutionWichita, Kansas  
Local InstitutionWilmington, North Carolina  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionAustin, Texas  
Comprehensive Cancer Center of NevadaLas Vegas, Nevada  89109
Baptist Cancer InstituteJacksonville, Florida  32207
Mercy Medical Research InstituteSpringfield, Missouri  65807