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

Uveal Melanoma Clinical Trial

— imMUno  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03964298
• Other study ID #: IC-2016-05
• Status: Enrolling by invitation
• Start date: November 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2019
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Locations

Country	Name	City	State
France	Rodrigues	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate Data collection of the efficacity of PD-1 inhibitors	Description of Response rate	December 2019
Primary	Progression Free Survival Data collection of the efficacity of PD-1 inhibitors	Description of PFS (Progression Free Survival)	December 2019
Primary	Global Survival Data collection of the efficacity of PD-1 inhibitors	Description of Global Survival	December 2019
Primary	Stability Data collection of the efficacity of PD-1 inhibitors	Description of Stability at 6 months	December 2019
Primary	Objective response Data collection of the efficacity of PD-1 inhibitors	Description of Objective response	December 2019
Secondary	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