MelanomaPost-ATUNCT03325257
Post-ATU Study of Nivolumab
An observational study of Melanoma, run by Nantes University Hospital at 17 sites in France.
Trial summary
Nivolumab obtained European Marketing authorization in June 2015. Before this date, a Temporary Authorization for Use (ATU) Program in France for nivolumab was set up between September 2014 and August 2015. This program enrolled approximately 600 melanoma patients (unresectable or metastatic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Routine care
- How many people
- 350 participants
- Where
- 17 sitesFrance
- Study dates
- 9 Mar 2017to 1 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients
Who may be able to join
- Patients with unresectable or metastatic melanoma cared in participating sites,
- Patients included in French nivolumab ATU program,
- Patients treated by at least one perfusion of nivolumab,
- Patients agreed to participate to the study.
Who cannot join
- Patients with unresectable or metastatic melanoma not included in French nivolumab ATU program,
- Patients having initiated Nivolumab after the 31th December 2015,
- Patients disagreed to participate.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Chu Amiens
Amiens, 80408
Hopital St andré-CHU DE Bordeaux
Bordeaux, 33000
Chu Clermont-Ferrand
Clermont-Ferrand, 63000
Chu Dijon
Dijon, 21000
CHU de Grenoble
Grenoble, La Tronche, 38700
CH du Mans
Le Mans, 72000
Chru Lille
Lille, 59000
Centre Léon Bérard de Lyon
Lyon, 69008
Hospices Civils de Lyon: Lyon Sud
Lyon, 69229
Hôpitaux de Marseille
Marseille, 13000
CHU NICE
Nice, 06000
AP-HP Hôpital Ambroise Paré
Paris, Boulogne Billancourt, 992100
CH de PAU
Pau, 64000
CHU de Rouen
Rouen, 76038
Chu Toulouse
Toulouse, 31000
Ch Valence
Valence, 26000
Institut Gustave Roussy
Villejuif, 94800
About this study
Official title: Two-years Follow-up of Melanoma Patients Treated by Nivolumab During the French ATU Program
Nivolumab obtained European Marketing authorization in June 2015. Before this date, a Temporary Authorization for Use (ATU) Program in France for nivolumab was set up between September 2014 and August 2015. This program enrolled approximately 600 melanoma patients (unresectable or metastatic).
It appears relevant to conduct a study on patients treated during the ATU to assess thoroughly patient characteristics, efficacy, safety, and patterns of use of nivolumab in real-life conditions.
Read the detailed description
In order to reach goals of this study, collaboration had been established between BMS and the RIC-Mel network (network for Research and Clinical Investigational Research on Melanoma) (NCT03315468).
The RIC-Mel network has set up a national database in order to reference the active file of melanoma patients in France. The RIC-Mel database, supported by Nantes University Hospital, had been approved by French authorities (CCTIRS and CNIL). The RIC-Mel network is coordinated by Pr B. DRENO (Nantes University Hospital) and Pr C. LEBBE (Saint-Louis Hospital, AP-HP, Paris). Nowadays, 49 centres located all over the country are participating, with more than 19,000 melanoma patients included in the database. The RIC-Mel database is referred as one of the privileged access to any research program on melanoma by the Cancerology Group (GCC) of the French Society of Dermatology .
Based on this, BMS and the RIC-Mel network had established a partnership to set up a study in order to estimate the overall survival of melanoma patients treated by Nivolumab during the French ATU program.
Data are collected in the RIC-Mel database by participating centres. Information of centres, follow-up of activity, data reviewing and extractions are realized by the RIC-Mel network. Data analysis is performed by BMS following a developed statistical protocol.
Patients included in the study were patients with unresectable or advanced metastatic melanoma, which received at least one of Nivolumab, dispensed during the French ATU program.
- Conditions
- Melanoma
- Being tested
- Routine care
- Keywords
- Unresectable melanoma, metastatic melanoma, Immunotherapy, Nivolumab, Temporary Auhorization for Use (ATU)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careOther
This study is an observational one - there is no change to the routine care. Patients received the Nivolumab independently of the study. Only data will be collected during this project.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival of patients included in the study thanks to subgroups of interest
Overall survival is defined as the time from index date (initiation of Nivolumab) until date of death due to any cause. Overall survival will be censored on the last date a subject was known to be alive. Estimates of survival rates will be realized for 1-year and 2-year survival. Median time will also be calculated.
Subgroups of interest are described in the description of the first Secondary Outcome Measure.
Safety Issue: No
Measured: 2 years
Secondary outcomes (7)
Distribution of melanoma patients included in the study in all subgroups of interest thanks to their clinical features at the time of treatment initiation
Subgroups of interest, based on information collected in medical records, were :
- ECOG performance status (PF). ECOG PF is attempted to quantify cancer patients' general well-being and activities of daily life. The classifications were 0, 1 or ≥2.
- LDH level. This level is considered as a prognostic factor: higher the LDH level, the worst the prognosis. The classifications were ≤Upper Limit of Normal (ULN), >ULN, >2 ULN or N/R (Unknown).
- History of brain metastasis. These metastases are considered as one of the most difficult-to-treat complications of melanoma. The classifications were No or Yes.
- Line of therapy. The classifications were 0, 1, 2 or >2.
- BRAF status. BRAF is a proto-oncogene. Melanoma patients with BRAF mutation are eligible to targeted therapy.The classifications were Yes (mutated), No (wild-type) and Unknown (no research).
- Number of metastatic sites. Safety Issue: No
Measured: Day 1
Proportion of melanoma patients included in the study categorized by genders overall and by subgroups of interest
Distribution of females and males. This analyse will be performed for all the study population and by subgroups of interest (as defined in the primary Outcome Measure).Safety Issue: No
Measured: Day 1
Distribution of age of melanoma patients included in the study overall and by subgroups of interest
Age of patients is the age at the start of Nivolumab treatment Safety Issue: No
Measured: Day 1
Description of Nivolumab treatment of melanoma patients included in the study
Average and median of Nivolumab treatment duration and infusion number will be assessed. Median time to discontinuation, whatever the reason and median time to discontinuation of dose related to adverse events. Distribution of reasons for discontinuation.
Safety Issue: No
Measured: 2 years
Incidence of select grade 3, 4 and 5 adverse events (AE) in melanoma patients included in the study and related to Nivolumab treatment
An AE is defined as any undesirable experience or manifestation associated with the use of a medical product in a patient. AEs are categorized by grades, which refer to severity : Grade 3 - Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living, Grade 4 - Life-threatening consequences, urgent intervention indicated, Grade 5 - Death related to AE. Proportion of patients with at least one or more select AE, distribution, average and median time of AE occurrence, duration and evolution of AEs as well as description of action on Nivolumab treatment will also be assessed.
Safety Issue: Yes
Measured: 2 years
Progression-free survival of melanoma patients included in the study
Progression-free survival is defined as the time since Nivolumab initiation to either the first disease progression date or at last known tumour assessment date, or death due to any cause, whichever occurs first.
Safety Issue: No
Measured: 2 years
Objective response rate of melanoma patients included in the study
Objective response rate as the number of subjects with a best objective response of either a partial response of a complete response. Objective response rate is the proportion of patients with an objective response. Safety Issue: No
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start9 Mar 2017
- Primary completion6 Sep 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Brigitte DRENO, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325257
- Sponsor's protocol ID
- RC17_0027
- Acronym
- Post-ATU
- Status last verified
- Sep 2021
- First submitted
- 13 Jul 2017
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-years Follow-up of Melanoma Patients Treated by Nivolumab During the French ATU Program
- ClinicalTrials.gov ID
- NCT03325257
- Acronym / sponsor ID
- Post-ATU / RC17_0027
- Conditions
- Melanoma
- Keywords
- Unresectable melanoma, metastatic melanoma, Immunotherapy, Nivolumab, Temporary Auhorization for Use (ATU)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 30 Oct 2017 (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.
Nivolumab obtained European Marketing authorization in June 2015. Before this date, a Temporary Authorization for Use (ATU) Program in France for nivolumab was set up between September 2014 and August 2015. This program enrolled approximately 600 melanoma patients (unresectable or metastatic).
It appears relevant to conduct a study on patients treated during the ATU to assess thoroughly patient characteristics, efficacy, safety, and patterns of use of nivolumab in real-life conditions.
Detailed description
In order to reach goals of this study, collaboration had been established between BMS and the RIC-Mel network (network for Research and Clinical Investigational Research on Melanoma) (NCT03315468).
The RIC-Mel network has set up a national database in order to reference the active file of melanoma patients in France. The RIC-Mel database, supported by Nantes University Hospital, had been approved by French authorities (CCTIRS and CNIL). The RIC-Mel network is coordinated by Pr B. DRENO (Nantes University Hospital) and Pr C. LEBBE (Saint-Louis Hospital, AP-HP, Paris). Nowadays, 49 centres located all over the country are participating, with more than 19,000 melanoma patients included in the database. The RIC-Mel database is referred as one of the privileged access to any research program on melanoma by the Cancerology Group (GCC) of the French Society of Dermatology .
Based on this, BMS and the RIC-Mel network had established a partnership to set up a study in order to estimate the overall survival of melanoma patients treated by Nivolumab during the French ATU program.
Data are collected in the RIC-Mel database by participating centres. Information of centres, follow-up of activity, data reviewing and extractions are realized by the RIC-Mel network. Data analysis is performed by BMS following a developed statistical protocol.
Patients included in the study were patients with unresectable or advanced metastatic melanoma, which received at least one of Nivolumab, dispensed during the French ATU program.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients
Key inclusion criteria (4 listed)
- Patients with unresectable or metastatic melanoma cared in participating sites,
- Patients included in French nivolumab ATU program,
- Patients treated by at least one perfusion of nivolumab,
- Patients agreed to participate to the study.
Key exclusion criteria (3 listed)
- Patients with unresectable or metastatic melanoma not included in French nivolumab ATU program,
- Patients having initiated Nivolumab after the 31th December 2015,
- Patients disagreed to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine careThis study is an observational one - there is no change to the routine care. Patients received the Nivolumab independently of the study. Only data will be collected during this project. | Other | – |
Primary outcome
Overall Survival of patients included in the study thanks to subgroups of interest
Time frame: 2 years
Overall survival is defined as the time from index date (initiation of Nivolumab) until date of death due to any cause. Overall survival will be censored on the last date a subject was known to be alive. Estimates of survival rates will be realized for 1-year and 2-year survival. Median time will also be calculated. Subgroups of interest are described in the description of the first Secondary Outcome Measure. Safety Issue: No
7 secondary outcomes
Distribution of melanoma patients included in the study in all subgroups of interest thanks to their clinical features at the time of treatment initiation
Time frame: Day 1
Proportion of melanoma patients included in the study categorized by genders overall and by subgroups of interest
Time frame: Day 1
Distribution of age of melanoma patients included in the study overall and by subgroups of interest
Time frame: Day 1
Description of Nivolumab treatment of melanoma patients included in the study
Time frame: 2 years
Incidence of select grade 3, 4 and 5 adverse events (AE) in melanoma patients included in the study and related to Nivolumab treatment
Time frame: 2 years
Progression-free survival of melanoma patients included in the study
Time frame: 2 years
Objective response rate of melanoma patients included in the study
Time frame: 2 years
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 14 Sep 2021.
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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.
Brigitte DRENO, PU-PH principal investigator
Nantes University Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Nantes University Hospital at 17 sites 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 4 inclusion and 3 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 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
Overall Survival of patients included in the study thanks to subgroups of interest (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2021.