MelanomaIMMUSPHINXNCT03627026
Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients
A study testing Blood samples will be collected at different time points: in people with Melanoma, run by Institut Claudius Regaud at 2 sites in France.
Trial summary
This trial is a translational proof-of-concept, open-label, prospective cohort study of 60 patients aiming to identify the clinical markers and/or biomarkers associated with therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Blood samples will be collected at different time points:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Jun 2019to 3 Jun 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years at the time of study entry.
- Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 8th edition), including mucosal melanoma, without intracranial active disease.
- Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone, nivolumab plus ipilimumab) has been decided.
- Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented.
- Patient must be naïve to immune checkpoint inhibitor treatment for locally advanced and/or metastatic disease (i.e., no prior treatment with ICI and current treatment with ICI not yet started).
- ECOG Performance status 0-2.
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- Life expectancy of at least 3 months.
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.
- Patient affiliated to a Social Health Insurance in France.
Who cannot join
- Patient pregnant, or breast-feeding.
- Uveal melanoma.
- Any condition contraindicated with sampling procedures required by the protocol.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
- Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection.
- Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Chu Nantes
Nantes, 44093
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, 31059
About this study
This trial is a translational proof-of-concept, open-label, prospective cohort study of 60 patients aiming to identify the clinical markers and/or biomarkers associated with therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma.
The study will be conducted on a population of patients treated with anti-PD-1 alone (nivolumab or pembrolizumab) or in combination (nivolumab + ipilimumab) in the context of routine care.
Read more
For each included patient, blood samples will be collected at different time points.
If feasible, an optional tumor biopsy specimen will be collected during baseline visit.
All included patients will be followed-up for tumor response and toxicity until Week 12.
After Week 12, survival data (tumor status and/or survival status) will be collected every 3 months until a maximum duration of 1 year from the first study dose.
- Conditions
- Melanoma
- Being tested
- Blood samples will be collected at different time points:
- Keywords
- Melanoma, Sphingolipids, Immune checkpoints, Tumor-infiltrating lymphocytes, Immunosuppressive cytokines, Circulating leukocytes
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples will be collected at different time points:Other
- Baseline
- Week 6 Day 1
- Week 12 Day 1
If feasible, an optional tumor biopsy specimen will be collected during baseline visit for a maximum of 30 patients included in IUCT-O center.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with immune checkpoint inhibitor | Other | Not described Receives: Other: Blood samples will be collected at different time points: |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the discriminant capacity to predict progression at 12 weeks evaluated using RECIST V1.1 criteria.
Measured: 12 weeks per patient
Secondary outcomes (3)
Objective response (i.e. complete or partial response) will be defined using RECIST V1.1 criteria at week 12.
Measured: 12 weeks per patient
Response duration is defined as the time from objective response until progression according to investigator judgment, or death.
Measured: 12 months per patient
Progression Free Survival is defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first.
Measured: 12 months per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start11 Jun 2019
- Primary completion8 Sep 2023
- Study completion3 Jun 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627026
- Sponsor's protocol ID
- 18 CUTA 05
- Acronym
- IMMUSPHINX
- Status last verified
- Jun 2024
- First submitted
- 8 Aug 2018
- Last updated
- 10 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients
- ClinicalTrials.gov ID
- NCT03627026
- Acronym / sponsor ID
- IMMUSPHINX / 18 CUTA 05
- Conditions
- Melanoma
- Keywords
- Melanoma, Sphingolipids, Immune checkpoints, Tumor-infiltrating lymphocytes, Immunosuppressive cytokines, Circulating leukocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 8 Sep 2023 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 13 Aug 2018 (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.
This trial is a translational proof-of-concept, open-label, prospective cohort study of 60 patients aiming to identify the clinical markers and/or biomarkers associated with therapeutic response to immune checkpoints inhibitors, in patients with advanced melanoma.
The study will be conducted on a population of patients treated with anti-PD-1 alone (nivolumab or pembrolizumab) or in combination (nivolumab + ipilimumab) in the context of routine care.
For each included patient, blood samples will be collected at different time points.
If feasible, an optional tumor biopsy specimen will be collected during baseline visit.
All included patients will be followed-up for tumor response and toxicity until Week 12.
After Week 12, survival data (tumor status and/or survival status) will be collected every 3 months until a maximum duration of 1 year from the first study dose.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with immune checkpoint inhibitor | Other | Other: Blood samples will be collected at different time points: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years at the time of study entry.
- Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 8th edition), including mucosal melanoma, without intracranial active disease.
- Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone, nivolumab plus ipilimumab) has been decided.
- Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented.
- Patient must be naïve to immune checkpoint inhibitor treatment for locally advanced and/or metastatic disease (i.e., no prior treatment with ICI and current treatment with ICI not yet started).
Key exclusion criteria (6 listed)
- Patient pregnant, or breast-feeding.
- Uveal melanoma.
- Any condition contraindicated with sampling procedures required by the protocol.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
- Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection.
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 |
|---|---|---|
| Blood samples will be collected at different time points:* Baseline * Week 6 Day 1 * Week 12 Day 1 If feasible, an optional tumor biopsy specimen will be collected during baseline visit for a maximum of 30 patients included in IUCT-O center. | Other | Patients treated with immune checkpoint inhibitor |
Primary outcome
The primary endpoint is the discriminant capacity to predict progression at 12 weeks evaluated using RECIST V1.1 criteria.
Time frame: 12 weeks per patient
3 secondary outcomes
Objective response (i.e. complete or partial response) will be defined using RECIST V1.1 criteria at week 12.
Time frame: 12 weeks per patient
Response duration is defined as the time from objective response until progression according to investigator judgment, or death.
Time frame: 12 months per patient
Progression Free Survival is defined as the time from inclusion until progression according to investigator judgment, or death, whichever occurs first.
Time frame: 12 months per patient
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 10 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples will be collected at different time points: in people with Melanoma, run by Institut Claudius Regaud at 2 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 9 inclusion and 6 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 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The primary endpoint is the discriminant capacity to predict progression at 12 weeks evaluated using RECIST V1.1 criteria. (time frame: 12 weeks per patient). 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 10 Jun 2024.