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

Primary Purpose

Melanoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ipilimumab
Chemotherapy
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birmingham Hematology & Oncology Associates Llc
  • Rocky Mountain Cancer Centers
  • Investigative Clinical Research Of Indiana, Llc
  • Cancer Center Of Kansas
  • Comprehensive Cancer Center Of Nevada
  • Lehigh Valley Hospital
  • Texas Oncology Sammons Cancer Center
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ipilimumab, 3 mg/kg

Chemotherapy

Arm Description

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

Participants received the investigator's choice of chemotherapy, administered per package instructions.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Disease Control Rate (DCR)
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)
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.

Full Information

First Posted
October 12, 2012
Last Updated
October 27, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01709162
Brief Title
Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Discontinued early due to enrollment challenges and changes in treatment standards
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipilimumab, 3 mg/kg
Arm Type
Experimental
Arm Description
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
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Participants received the investigator's choice of chemotherapy, administered per package instructions.
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy, BMS-734016
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Primary Outcome Measure Information:
Title
Overall Survival
Description
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)
Time Frame
From randomization to death or last known alive date, assessed up to 15.6 months
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
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.
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
Title
Best Overall Response Rate (BORR)
Description
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.
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
Other Pre-specified Outcome Measures:
Title
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)
Description
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.
Time Frame
From Day 1 of treatment to 90 days after last dose (or to death date for death information)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Hematology & Oncology Associates Llc
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Investigative Clinical Research Of Indiana, Llc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Cancer Center Of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Comprehensive Cancer Center Of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Texas Oncology Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Local Institution
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Local Institution
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Local Institution
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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

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