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

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

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75005
      • Rodrigues

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with metastatic uveal melanoma.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate Data collection of the efficacity of PD-1 inhibitors	Description of Response rate	December 2019
Progression Free Survival Data collection of the efficacity of PD-1 inhibitors	Description of PFS (Progression Free Survival)	December 2019
Global Survival Data collection of the efficacity of PD-1 inhibitors	Description of Global Survival	December 2019
Stability Data collection of the efficacity of PD-1 inhibitors	Description of Stability at 6 months	December 2019
Objective response Data collection of the efficacity of PD-1 inhibitors	Description of Objective response	December 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploration of PD-1 inhibitors biomarkers	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.	December 2019

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Study Director: Manuel Rodrigues, MD, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Eye Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Uveal Diseases; Neuroendocrine Tumors; Nevi and Melanomas; Eye Neoplasms; Melanoma; Uveal Neoplasms
• Other Study ID Numbers: IC-2016-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No