Uveal MelanomaimMUnoNCT03964298
Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma
An observational study of Uveal Melanoma, run by Institut Curie at 1 site in France.
Trial summary
Study of the activity of PD-1 inhibitors in metastatic uveal melanoma Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uveal Melanoma
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with metastatic uveal melanoma.
Who may be able to join
- Patients with metastatic uveal melanoma
- Patients who received at least once injection of Nivolumab or Pembrolizumab in the case of the disease's treatment
Who cannot join
- Antecedent of another evolutionary tumor pathology
Trial locations and contacts
1 site in 1 country.
About this study
Study of the activity of PD-1 inhibitors in metastatic uveal melanoma
Read the 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.
- Conditions
- Uveal Melanoma
- Medical subject headings
- Uveal Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate Data collection of the efficacity of PD-1 inhibitors
Description of Response rate
Measured: December 2019
Progression Free Survival Data collection of the efficacity of PD-1 inhibitors
Description of PFS (Progression Free Survival)
Measured: December 2019
Global Survival Data collection of the efficacity of PD-1 inhibitors
Description of Global Survival
Measured: December 2019
Stability Data collection of the efficacity of PD-1 inhibitors
Description of Stability at 6 months
Measured: December 2019
Objective response Data collection of the efficacity of PD-1 inhibitors
Description of Objective response
Measured: December 2019
Secondary outcomes (1)
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.
Measured: December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study startNov 2016
- Primary completionNov 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Rodrigues, MD, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964298
- Sponsor's protocol ID
- IC-2016-05
- Acronym
- imMUno
- Status last verified
- Aug 2025
- First submitted
- 12 Jul 2017
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35863105
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Activity of PD-1 Inhibitors in Metastatic Uveal Melanoma
- ClinicalTrials.gov ID
- NCT03964298
- Acronym / sponsor ID
- imMUno / IC-2016-05
- Conditions
- Uveal Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with metastatic uveal melanoma.
Key inclusion criteria (2 listed)
- Patients with metastatic uveal melanoma
- Patients who received at least once injection of Nivolumab or Pembrolizumab in the case of the disease's treatment
Key exclusion criteria (1 listed)
- Antecedent of another evolutionary tumor pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response rate Data collection of the efficacity of PD-1 inhibitors
Time frame: December 2019
Description of Response rate
Progression Free Survival Data collection of the efficacity of PD-1 inhibitors
Time frame: December 2019
Description of PFS (Progression Free Survival)
Global Survival Data collection of the efficacity of PD-1 inhibitors
Time frame: December 2019
Description of Global Survival
Stability Data collection of the efficacity of PD-1 inhibitors
Time frame: December 2019
Description of Stability at 6 months
Objective response Data collection of the efficacity of PD-1 inhibitors
Time frame: December 2019
Description of Objective response
1 secondary outcome
Exploration of PD-1 inhibitors biomarkers
Time frame: December 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Results publication: PubMed 35863105Saint-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Rodrigues, MD study director
Institut Curie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveal Melanoma, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate Data collection of the efficacity of PD-1 inhibitors (time frame: December 2019). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03964298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.