MelanomaPHENOMENALNCT06154668
Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients
An observational study of Melanoma, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Despite being standard of care, there are still many medical requirements related to immune checkpoint blocker based therapies such as identify patients susceptible to respond with the less adverse events, evaluate the clinical benefit of adjuvant treatment /risk of relapse and design new strategies for non-responder… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- How many people
- 707 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2024to Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with unresectable (stage III) or metastatic (stage IV) melanoma, followed at CHU Grenoble - Alpes in Dermatology deparment for diagnosis, follow-up or recurrence of melanoma, and treated with immune checkpoint blocker in curative or adjuvant setting.
Who may be able to join
- Patient with histologically confirmed melanoma (stage I, II, III or IV based on AJCC classification)
- Able to sign the informed collection consent for the retrospective part or to express their non-opposition to the research for the prospective part of the study
Who cannot join
- Subject under guardianship or subject deprived of freedom
- Persons benefiting from special protection (as defined in Articles L1121-5 and L1121-8 of the Public Health Code): minors, pregnant or breastfeeding women, adults protected by law (under guardianship, curatorship or deprived of liberty) and persons hospitalized without their consent (as defined in Articles L3212-1 and L3212-3 of the Public Health Code).
- ocular melanoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes
Grenoble, 38043
Stéphane MOURET, +33 (0)4 76 76 7081, SMouret1@chu-grenoble.fr
Julie CHARLES
About this study
Official title: Phenotypic, Functional, Metabolic and Transcriptomic Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients
Despite being standard of care, there are still many medical requirements related to immune checkpoint blocker based therapies such as identify patients susceptible to respond with the less adverse events, evaluate the clinical benefit of adjuvant treatment /risk of relapse and design new strategies for non-responder patients.
Thus, this project aims at understanding the impact of anti-PD1 on the immune system through investigation of the phenotypic, functional, metabolic and transcriptomic profiles of circulating DC subsets and effectors in response to anti-PD1 therapy in melanoma patients.
The primary objective of the study is to identify the biomarkers of response to anti-PD1 according to the type of patient before the start of the treatment.
- Conditions
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort #A | monotherapy anti-PD1 first line | |
| Cohort #B | monotherapy anti-PD1 second line | |
| Cohort #C | monotherapy anti-PD1 adjuvant | |
| Cohort #D | combotherapy anti-PD1/CTLA-4 first line | |
| Cohort #E | untreated stage I and II melanoma patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of biomarkers of response to anti6PD1 according to the type of patient before the start of treatment
response to treatment according to immunological parameters at T0 between patients responding (R), stable (SD) and non-responding (NR) to treatment
Measured: 6 months
Secondary outcomes (1)
identification of early biomarkers predictive of the response to anti-PD1
comparison of immunological parameters according to the type of patients (R, SD and NR) for each time point
Measured: at each time point (3, 4 or 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start17 Jan 2024
- Primary completionJan 2030 (estimated)
- Study completionJan 2031 (estimated)
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.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 707 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Etablissement Français du Sang
- Responsible party
- Sponsor
- Investigators
- Julie Charles, MD, PhD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154668
- Sponsor's protocol ID
- 38RC23.0280
- Other IDs
- 2023-A01722-43
- Acronym
- PHENOMENAL
- Status last verified
- Feb 2024
- First submitted
- 23 Nov 2023
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic, Functional, Metabolic and Transcriptomic Profiling of Circulating Immune Cells to Uncover Response Signatures to Anti-PD1 Immunotherapy in Melanoma Patients
- ClinicalTrials.gov ID
- NCT06154668
- Acronym / sponsor ID
- PHENOMENAL / 38RC23.0280
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 707 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Etablissement Français du Sang
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 4 Dec 2023 (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.
Despite being standard of care, there are still many medical requirements related to immune checkpoint blocker based therapies such as identify patients susceptible to respond with the less adverse events, evaluate the clinical benefit of adjuvant treatment /risk of relapse and design new strategies for non-responder patients.
Thus, this project aims at understanding the impact of anti-PD1 on the immune system through investigation of the phenotypic, functional, metabolic and transcriptomic profiles of circulating DC subsets and effectors in response to anti-PD1 therapy in melanoma patients.
The primary objective of the study is to identify the biomarkers of response to anti-PD1 according to the type of patient before the start of the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort #A | – | –monotherapy anti-PD1 first line |
| Cohort #B | – | –monotherapy anti-PD1 second line |
| Cohort #C | – | –monotherapy anti-PD1 adjuvant |
| Cohort #D | – | –combotherapy anti-PD1/CTLA-4 first line |
| Cohort #E | – | –untreated stage I and II melanoma patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable (stage III) or metastatic (stage IV) melanoma, followed at CHU Grenoble - Alpes in Dermatology deparment for diagnosis, follow-up or recurrence of melanoma, and treated with immune checkpoint blocker in curative or adjuvant setting.
Key inclusion criteria (2 listed)
- Patient with histologically confirmed melanoma (stage I, II, III or IV based on AJCC classification)
- Able to sign the informed collection consent for the retrospective part or to express their non-opposition to the research for the prospective part of the study
Key exclusion criteria (3 listed)
- Subject under guardianship or subject deprived of freedom
- Persons benefiting from special protection (as defined in Articles L1121-5 and L1121-8 of the Public Health Code): minors, pregnant or breastfeeding women, adults protected by law (under guardianship, curatorship or deprived of liberty) and persons hospitalized without their consent (as defined in Articles L3212-1 and L3212-3 of the Public Health Code).
- ocular melanoma
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
Identification of biomarkers of response to anti6PD1 according to the type of patient before the start of treatment
Time frame: 6 months
response to treatment according to immunological parameters at T0 between patients responding (R), stable (SD) and non-responding (NR) to treatment
1 secondary outcome
identification of early biomarkers predictive of the response to anti-PD1
Time frame: at each time point (3, 4 or 6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 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.
Julie Charles, MD, PhD principal investigator
CHU Grenoble Alpes
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 Melanoma, run by University Hospital, Grenoble 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 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: looking for participants now, as of the sponsor's last update on 20 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Charles, MD, PhD (476769320 ext. 33, jcharles@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of biomarkers of response to anti6PD1 according to the type of patient before the start of treatment (time frame: 6 months). 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 20 Feb 2024.