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Completed

NCT Number: NCT03964298

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

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

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Key information

Conditions

Uveal Melanoma Eye Diseases Eye Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Uveal Diseases Uveal Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Rodrigues

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

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Acronym: imMUno

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
May 28, 2019
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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