Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients (IMMUSPHINX)
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|ClinicalTrials.gov Identifier: NCT03627026|
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : March 18, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Other: Blood samples will be collected at different time points:||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||June 2021|
|Patients treated with immune checkpoint inhibitor||
Other: Blood samples will be collected at different time points:
If feasible, an optional tumor biopsy specimen will be collected during baseline visit for a maximum of 30 patients included in IUCT-O center.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627026
|Contact: Nicolas MEYER, MD, PhD||05 31 15 60 email@example.com|
|Chu Nantes||Not yet recruiting|
|Nantes, France, 44093|
|Contact: Brigitte DRENO 02 40 08 31 18 firstname.lastname@example.org|
|Institut Universitaire Du Cancer de Toulouse - Oncopole||Recruiting|
|Toulouse, France, 31059|
|Contact: Nicolas MEYER, MD, PhD 05 31 15 60 34 email@example.com|