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Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma (imMUno)

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.
 
ClinicalTrials.gov Identifier: NCT03964298
Recruitment Status : Enrolling by invitation
First Posted : May 28, 2019
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Tracking Information
First Submitted Date July 12, 2017
First Posted Date May 28, 2019
Last Update Posted Date October 31, 2019
Actual Study Start Date November 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2019)
  • Response rate Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of Response rate
  • Progression Free Survival Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of PFS (Progression Free Survival)
  • Global Survival Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of Global Survival
  • Stability Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of Stability at 6 months
  • Objective response Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of Objective response
Original Primary Outcome Measures
 (submitted: May 24, 2019)
  • Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of Response rate
  • Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of PFS (Progression Free Survival)
  • Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of Global Survival
  • Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of Stability at 6 months
  • Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of Objective response
Change History
Current Secondary Outcome Measures
 (submitted: May 24, 2019)
Exploration of PD-1 inhibitors biomarkers [ Time Frame: December 2019 ]
The study of PD-1 inhibitors biomarkers could be useful to identify a group of patients whose the molecules are most activated and then for futures studies.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma
Official Title Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma
Brief Summary Study of the activity of PD-1 inhibitors in metastatic uveal melanoma
Detailed Description The aim of the research is to study the activity of PD-1 inhibitors in patients with metastatic uveal melanoma and treated by Nivolumab and Pembrolizumab. These molecules have already received the authorities approvals. The data collected will be crucial for the understanding of the mechanism of PD-1 inhibitors and also for the futures studies.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Biocollection of tumoral tissues
Sampling Method Probability Sample
Study Population Patients with metastatic uveal melanoma.
Condition Uveal Melanoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 24, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with metastatic uveal melanoma
  • Patients who received at least once injection of Nivolumab or Pembrolizumab in the case of the disease's treatment

Exclusion Criteria:

  • Antecedent of another evolutionary tumor pathology
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03964298
Other Study ID Numbers IC-2016-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Institut Curie
Study Sponsor Institut Curie
Collaborators Not Provided
Investigators
Study Director: Manuel Rodrigues, MD Institut Curie
PRS Account Institut Curie
Verification Date October 2019