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Study to Compare the Effect of Ipilimumab Retreatment With Chemotherapy in Advanced Melanoma

This study is currently recruiting participants.
Verified May 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01709162
First received: October 12, 2012
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Melanoma
 Biological: Ipilimumab
Drug: Chemotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Ipilimumab
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Survival rate [ Time Frame: At 18 months from Last Patient First Visit (LPFV) ] [ Designated as safety issue: No ]
    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

  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Overall survival is defined for each subject as the time between randomization and death. If a subject has not died, the subject will be censored at the time of last contact (last known alive date)


Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

    PFS is defined for each subject as the time between randomization date and the date of progression or death, whichever occurs first.

    Time frame: Every 3 months until 18 months, then every 6 months thereafter


  • Best Overall Response Rate (BORR) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

    BORR is defined by treatment arm as the total number of randomized subjects in the arm whose Best Overall Response (BOR) is Complete response (CR) or Partial response (PR), divided by the total number of randomized subjects in the arm.

    Time frame: Every 3 months until 18 months, then every 6 months thereafter


  • Quality of life outcomes measured by European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 score [ Time Frame: At Baseline (week 1 prior to first dose) and up to 5 years ] [ Designated as safety issue: No ]
    Time frame: At Baseline (week 1 prior to first dose), during treatment (every 6 weeks, always prior to dosing), at end of treatment, and at all visits thereafter


Estimated Enrollment: 138
Study Start Date: March 2013
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab 3mg/kg
Ipilimumab 3mg/kg (5mg/ml sterile solution for infusion), Intravenous (IV) infusion, every 3 weeks for 10 weeks (4 doses in total)
 Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
Active Comparator: Chemotherapy of Investigator's choice
Active comparator arm is chemotherapy as per investigator's choice and the interventions will be provided as per package instructions. Detailed specifications cannot be provided, as the drug(s) used in the comparator arm are not predefined
 Drug: Chemotherapy

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709162

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Show 36 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01709162     History of Changes
Other Study ID Numbers: CA184-243, 2012-003291-38
Study First Received: October 12, 2012
Last Updated: May 16, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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 May 22, 2013