NCT03964298

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2017

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

July 12, 2017

Last Update Submit

August 7, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • Exploration of PD-1 inhibitors biomarkers

    December 2019

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with metastatic uveal melanoma.

You may qualify if:

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

You may not qualify if:

  • Antecedent of another evolutionary tumor pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rodrigues

Paris, Île-de-France Region, 75005, France

Location

Related Publications (1)

  • Saint-Ghislain M, Derrien AC, Geoffrois L, Gastaud L, Lesimple T, Negrier S, Penel N, Kurtz JE, Le Corre Y, Dutriaux C, Gardrat S, Barnhill R, Matet A, Cassoux N, Houy A, Ramtohul T, Servois V, Mariani P, Piperno-Neumann S, Stern MH, Rodrigues M. MBD4 deficiency is predictive of response to immune checkpoint inhibitors in metastatic uveal melanoma patients. Eur J Cancer. 2022 Sep;173:105-112. doi: 10.1016/j.ejca.2022.06.033. Epub 2022 Jul 19.

Biospecimen

Retention: SAMPLES WITH DNA

Biocollection of tumoral tissues

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Study Officials

  • Manuel Rodrigues, MD

    Institut Curie

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2017

First Posted

May 28, 2019

Study Start

November 1, 2016

Primary Completion

November 1, 2019

Study Completion

December 1, 2020

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations