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

• Conditions: Uveal Melanoma

• Registration Number: NCT03964298
• Lead Sponsor: Institut Curie

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-28
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-31
• Primary Completion: 2019-11
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Exploration of PD-1 inhibitors biomarkers	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.

Trial Locations

Locations (1)

Rodrigues; 🇫🇷 Paris, Ile-de-France, France