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

This study has been terminated.
(Discontinued early due to enrollment challenges and changes in treatment standards)
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01709162
First received: October 12, 2012
Last updated: October 27, 2015
Last verified: September 2015
  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: From randomization to death or last known alive date, assessed up to 15.6 months ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Disease Control Rate (DCR) [ 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 ] [ Designated as safety issue: No ]
    DCR is defined per arm as the total number of randomized participants with best overall response as complete response, partial response, or stable disease, divided by the total number of randomized participants in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined time frame. Thus, no participants were analyzed. Because the study ended before best overall response could be determined, no participants were analyzed.

  • Best Overall Response Rate (BORR) [ 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 ] [ Designated as safety issue: No ]
    BORR is defined per arm as the total number of randomized patients with a best overall response of complete response or partial response, divided by the total number of randomized patients in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined timeframe. Because the study ended before best overall response for all patients was defined, no participant data was analyzed.


Other Outcome Measures:
  • Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs) [ Time Frame: From Day 1 of treatment to 90 days after last dose (or to death date for death information) ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=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.


Enrollment: 31
Study Start Date: March 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ipilimumab, 3 mg/kg
Participants 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
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
Active Comparator: Chemotherapy
Participants received the investigator's choice of chemotherapy, administered per package instructions.
Drug: Chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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
  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
Erfurt, Germany, 99089
Local Institution
Goettingen, Germany, 37075
Local Institution
Heidelberg, Germany, 69115
Local Institution
Kiel, Germany, 24105
Local Institution
Koln, Germany, 50937
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:
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
Results First Received: September 17, 2015
Last Updated: October 27, 2015
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
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016