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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

Brief Summary:
Study of the activity of PD-1 inhibitors in metastatic uveal melanoma

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma
Actual Study Start Date : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019





Primary Outcome Measures :
  1. Response rate Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of Response rate

  2. Progression Free Survival Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of PFS (Progression Free Survival)

  3. Global Survival Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of Global Survival

  4. Stability Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of Stability at 6 months

  5. Objective response Data collection of the efficacity of PD-1 inhibitors [ Time Frame: December 2019 ]
    Description of Objective response


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Biocollection of tumoral tissues


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with metastatic uveal melanoma.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964298


Locations
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France
Rodrigues
Paris, Ile-de-France, France, 75005
Sponsors and Collaborators
Institut Curie
Investigators
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Study Director: Manuel Rodrigues, MD Institut Curie
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT03964298    
Other Study ID Numbers: IC-2016-05
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases