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Ipilimumab With Lymphodepletion Plus Adoptive Cell Transfer and High Dose IL-2 in Melanoma Mets Pts

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Lion Biotechnologies
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01701674
First received: October 3, 2012
Last updated: May 12, 2017
Last verified: March 2017
Results First Received: March 22, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Metastatic Melanoma
Interventions: Drug: Ipilimumab
Procedure: Tumor Infiltrating Lymphocytes (TIL)
Drug: Administration of Lymphodepletion
Drug: Cyclophosphamide as Part of Lymphodepletion
Drug: Fludarabine as Part of Lymphodepletion
Drug: High Dose IL-2
Biological: Adoptive Cell Therapy with TIL

  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 at Moffitt Cancer Center, April 2013 through July 2014.

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
Experimental: Combination Therapy The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.

Participant Flow:   Overall Study
    Experimental: Combination Therapy
STARTED   13 
COMPLETED   12 
NOT COMPLETED   1 
Unable to safely complete treatment                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 participants (13). All evaluable participants (12) may be referenced for some outcome measures.

Reporting Groups
  Description
Experimental: Combination Therapy The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.

Baseline Measures
   Experimental: Combination Therapy 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      10  76.9% 
>=65 years      3  23.1% 
Age 
[Units: Years]
Mean (Full Range)
 49 
 (22 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  46.2% 
Male      7  53.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Occurrence of Dose Limiting Toxicity (DLT) Events   [ Time Frame: 3 months ]

2.  Primary:   Rate of Meeting Feasibility Requirements   [ Time Frame: 3 months ]

3.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   10/2017  

4.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: 3 months ]
Results not yet reported.   Anticipated Reporting Date:   10/2017  


  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. Amod Sarnaik
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-8581
e-mail: amod.sarnaik@moffitt.org



Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01701674     History of Changes
Other Study ID Numbers: MCC-17057
CA184-213 ( Other Identifier: Bristol-Myers Squibb )
Study First Received: October 3, 2012
Results First Received: March 22, 2017
Last Updated: May 12, 2017