Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01134614
First received: April 27, 2010
Last updated: March 23, 2015
Last verified: March 2015
Results First Received: March 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Melanoma
Stage III Melanoma
Stage IV Melanoma
Interventions: Biological: ipilimumab
Biological: sargramostim

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from ECOG member institutions between December 28, 2010 and July 28, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A (Ipilimumab and Sargramostim)

ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.

ipilimumab: Given IV

sargramostim: Given SC

Arm B (Ipilimumab)

ARM B: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, anti-tumor response is assessed and patients then receive maintenance therapy of ipilimumab IV over 90 minutes on day 1. Treatment with ipilimumab repeats every 12 weeks. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

ipilimumab: Given IV


Participant Flow:   Overall Study
    Arm A (Ipilimumab and Sargramostim)     Arm B (Ipilimumab)  
STARTED     123     122  
Treated     119     121  
Treated and Toxicity Assessed     118     120  
COMPLETED     0 [1]   0 [2]
NOT COMPLETED     123     122  
Still on treatment as of March 2013                 21                 13  
Progressive disease                 60                 54  
Adverse Event                 26                 39  
Death                 5                 8  
Withdrawal by Subject                 3                 2  
Alternative therapy                 2                 0  
Complicating disease                 2                 1  
Physician's decision                 0                 1  
Never started treatment                 4                 1  
Pt received tx not allowed on study                 0                 1  
Symptomatic deterioration                 0                 1  
Patient in hospice care                 0                 1  
[1] Treatment continues until disease progression or unacceptable toxicity.
[2] Treatment continues until disease progression or unacceptable toxicities



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized patients are included in this analysis.

Reporting Groups
  Description
Arm A (Ipilimumab and Sargramostim)

ARM A: Patients receive induction therapy comprising ipilimumab intravenously (IV) over 90 minutes on day 1 and sargramostim subcutaneously (SC) once daily on days 1-14. Treatment repeats every 21 days for 4 cycles. After 12 weeks of induction treatment, patients then receive maintenance therapy comprising ipilimumab IV over 90 minutes on day 1 and sargramostim SC once daily on days 1-14. Treatment with ipilimumab repeats every 12 weeks and treatment with sargramostim repeats every 21 days. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy until disease progression or unacceptable toxicity.

ipilimumab: Given IV

sargramostim: Given SC

Arm B (Ipilimumab)

ARM B: Patients receive induction therapy comprising ipilimumab as in arm A. Patients then receive maintenance therapy comprising ipilimumab IV as in arm A. After 12 weeks of maintenance therapy, anti-tumor response is reassessed and patients with responsive or stable disease then continue maintenance therapy comprising ipilimumab IV as in arm A. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

ipilimumab: Given IV

Total Total of all reporting groups

Baseline Measures
    Arm A (Ipilimumab and Sargramostim)     Arm B (Ipilimumab)     Total  
Number of Participants  
[units: participants]
  123     122     245  
Age  
[units: years]
Median (Full Range)
  61    (25 to 86)     64    (21 to 89)     63    (21 to 89)  
Gender  
[units: participants]
     
Female     38     44     82  
Male     85     78     163  
Region of Enrollment  
[units: participants]
     
United States     123     122     245  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years ]

2.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years ]

3.  Secondary:   Proportion of Patients With Objective Response   [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


Publications:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01134614     History of Changes
Other Study ID Numbers: NCI-2011-02039, NCI-2011-02039, E1608, U10CA021115
Study First Received: April 27, 2010
Results First Received: March 23, 2015
Last Updated: March 23, 2015
Health Authority: United States: Food and Drug Administration