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Yervoy With Sylatron Unresectable Stage 3 or 4 Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496807
First Posted: December 21, 2011
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
Results First Submitted: January 31, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Melanoma
Interventions: Drug: Sylatron
Drug: Yervoy

  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
Between February 17, 2012 and December 5, 2013, 33 patients were screened and 31 patients were enrolled on treatment at Moffitt Cancer Center.

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
Yervoy With Sylatron Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).

Participant Flow:   Overall Study
    Yervoy With Sylatron
STARTED   31 
COMPLETED   1 
NOT COMPLETED   30 
Progressive Disease                21 
Participant preference/toxicity                8 
Change in diagnosis                1 



  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 evaluable participants will be those who completed treatment per study criteria.

Reporting Groups
  Description
Yervoy With Sylatron Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).

Baseline Measures
   Yervoy With Sylatron 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      14  45.2% 
>=65 years      17  54.8% 
Age 
[Units: Years]
Median (Full Range)
 65 
 (38 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      13  41.9% 
Male      18  58.1% 
Region of Enrollment 
[Units: Participants]
 
United States   31 


  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (MTD) of Sylatron   [ Time Frame: Up to 48 Months ]

2.  Primary:   Maximum Tolerated Dose (MTD) of Ipilimumab   [ Time Frame: Up to 48 Months ]

3.  Secondary:   Number of Participants With Overall Response (OR)   [ Time Frame: Up to 54 Months ]

4.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Up to 54 Months ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 54 Months ]

6.  Secondary:   Treatment Related Adverse Events (AEs) - Grade 3 to 5   [ Time Frame: 4 Years, 1 Month ]

7.  Other Pre-specified:   Count of Participants Developing Positive Autoantibody Screen   [ Time Frame: Up to 54 Months ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Andrew Brohl
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-3242
e-mail: andrew.brohl@moffitt.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01496807     History of Changes
Other Study ID Numbers: MCC-16755
First Submitted: December 19, 2011
First Posted: December 21, 2011
Results First Submitted: January 31, 2017
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017