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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01709162
First received: October 12, 2012
Last updated: September 22, 2014
Last verified: September 2014
  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:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall survival [ Time Frame: At 76 deaths (approximately 40 months) ] [ 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:
  • Disease Control Rate (DCR) [ Time Frame: Approximately up to 7 years ] [ Designated as safety issue: No ]

    DCR is defined by randomized arm as the total number of randomized subjects in the arm whose Best Overall Response (BOR) is Complete response (CR) or Partial response (PR) or Stable Disease(SD), divided by the total number of randomized subjects in the arm

    Time Frame: Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease (PD)


  • Best Overall Response Rate (BORR) [ Time Frame: Approximately up to 7 years ] [ Designated as safety issue: No ]

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

    Time Frame: Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease (PD)


  • European Organisation for Research and Treatment of Cancer(EORTC)-QLQ-C30 between retreatment with ipilimumab versus chemotherapy of investigator's choice [ Time Frame: Approximately up to 7 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 (approximately at week 12), and at all visits thereafter


Estimated Enrollment: 23
Study Start Date: November 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (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 more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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
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: NCT01709162

Locations
United States, Alabama
Birmingham Hematology & Oncology Associates Llc
Birmingham, Alabama, United States, 35205
United States, Colorado
Rocky Mountain Cancer Centers
Aurora, Colorado, United States, 80012
United States, Indiana
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, United States, 46260
United States, Kansas
Cancer Center Of Kansas
Wichita, Kansas, United States, 67214
United States, Nevada
Comprehensive Cancer Center Of Nevada
Las Vegas, Nevada, United States, 89148
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
United States, Texas
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States, 75246
Austria
Local Institution
Wien, Austria, A-1090
France
Local Institution
Bordeaux, France, 33075
Local Institution
Nantes Cedex 1, France, 44093
Local Institution
Paris, France, 75010
Germany
Local Institution
Augsburg, Germany, 86179
Local Institution
Erfurt, Germany, 99089
Local Institution
Goettingen, Germany, 37075
Local Institution
Heidelberg, Germany, 69115
Local Institution
Kiel, Germany, 24105
Local Institution
Koln, Germany, 50937
Local Institution
Muenster, Germany, 48149
Local Institution
Regensburg, Germany, 93053
Local Institution
Tubingen, Germany, 72076
Italy
Local Institution
Siena, Italy, 53100
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: NCT01709162     History of Changes
Other Study ID Numbers: CA184-243, 2012-003291-38
Study First Received: October 12, 2012
Last Updated: September 22, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
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
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2014