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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
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Patients treated with immune checkpoint inhibitor Other: 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.





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Response duration is defined as the time from objective response until progression according to investigator judgment, or death. [ Time Frame: 12 months per patient ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years at the time of study entry.
  2. Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 8th edition), including mucosal melanoma, without intracranial disease.
  3. Patient for which a treatment with immune checkpoint inhibitor (nivolumab alone, pembrolizumab alone, nivolumab plus ipilimumab) has been decided.
  4. Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented.
  5. 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).
  6. Measurable disease per RECIST 1.1.
  7. ECOG Performance status 0-2.
  8. Life expectancy of at least 3 months.
  9. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.
  10. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

  1. Patient pregnant, or breast-feeding.
  2. Uveal melanoma.
  3. Any condition contraindicated with sampling procedures required by the protocol.
  4. 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.
  5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection.
  6. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.

Information from the National Library of Medicine

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


Contacts
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Contact: Nicolas MEYER, MD, PhD 05 31 15 60 34 meyer.n@chu-toulouse.fr

Locations
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France
Chu Nantes Not yet recruiting
Nantes, France, 44093
Contact: Brigitte DRENO    02 40 08 31 18    brigitte.dreno@chu-nantes.fr   
Institut Universitaire Du Cancer de Toulouse - Oncopole Recruiting
Toulouse, France, 31059
Contact: Nicolas MEYER, MD, PhD    05 31 15 60 34    meyer.n@chu-toulouse.fr   
Sponsors and Collaborators
Institut Claudius Regaud

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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT03627026     History of Changes
Other Study ID Numbers: 18 CUTA 05
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Claudius Regaud:
Melanoma
Sphingolipids
Immune checkpoints
Tumor-infiltrating lymphocytes
Immunosuppressive cytokines
Circulating leukocytes

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas