Evaluation of Sphingolipids as Predictive Biomarkers of Immune Checkpoint Inhibitor Response in Melanoma Patients

NCT ID: NCT03627026

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-11
• Study Completion Date: 2024-06-03

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients treated with immune checkpoint inhibitor

Group Type: OTHER

Blood samples will be collected at different time points:

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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 active 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. ECOG Performance status 0-2.

7. Life expectancy of at least 3 months.

8. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.

9. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Claudius Regaud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Nantes

Nantes, , France

Institut Universitaire Du Cancer de Toulouse - Oncopole

Toulouse, , France

Countries

France

Other Identifiers

18 CUTA 05

Identifier Type: -

Identifier Source: org_study_id