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Adoptive Transfer of Specific Melanoma Antigens CD8+ T Cells in Metastatic Melanoma Patients: a Phase I/II Study (MelSort)

Primary Purpose

Metastatic Melanoma

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Melanoma antigens-specific CD8+ T lymphocytes
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring Onco-dermatology, Adoptive transfer, Immunotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female ≥ 18 and ≤ 75 years
  • Patient expressing the HLA-A*0201 subtype of the human leukocyte antigen (HLA -A2)
  • Patient with metastatic melanoma stage IIIc or IV (AJCC 2010) except brain metastases
  • Tumor expressing the antigens Melan-A and MELOE-1 detected by RT-PCR
  • Absence of cerebral metastases
  • ECOG ≤ 1 or Karnofsky ≥ 80%
  • Prior adjuvant melanoma treatment (before metastatic stage) authorized (anti- BRAF, anti-CTLA4, IFN, TIL... )
  • Disease measurable / evaluable within 28 days before the first administration of study treatment
  • Negative viral serology (HIV 1/2, Ag p24 , HTLV 1/2 , hepatitis B and C, syphilis)

  • Results of analysis:

    • Hemoglobin ≥ 10 g / dl or ≥ 6.25 mmol / l
    • Leukocytes ≥ 4000/μl
    • Lymphocytes ≥ 1500/μl
    • Platelets ≥ 80.000/μl
    • Creatinine ≤ 2.5 N
    • Total bilirubin ≤ 3 N
    • AST and ALT ≤ 3 N without liver metastases; ≤ 5 N with liver metastases
  • Negative pregnancy test for women of childbearing age
  • Patient affiliated to a social security system
  • Patient who has signed informed consent

Exclusion Criteria:

  • Brain metastases
  • Ocular primitive melanoma
  • Treatment of metastatic melanoma by more than two lines (chemotherapy , immunotherapy, targeted therapy or radiotherapy) or within 4 weeks before the inclusion
  • Treatment with ipilimumab within 8 weeks before the inclusion
  • Known allergy to albumin
  • Contraindication to the use of vasopressors
  • Positive viral serology for HIV 1/2 , Ag p24 , HTLV 1/2, hepatitis B or C, or syphilis
  • Women who are pregnant, nursing or refusing to use contraceptives, women with no negative pregnancy test at baseline
  • Presence of a second active cancer (with the exception of cervical cancer in situ or skin cancer other than melanoma)
  • History of event or current event of a progressive or non-stabilized severe heart disease (congestive heart failure, coronary artery disease, uncontrolled hypertension, serious arrhythmias or ECG signs of previous myocardial infarction)
  • Uncontrolled thyroid dysfunction
  • Any serious acute or chronic illness (active infection requiring antibiotics, bleeding disorders or other condition requiring concomitant treatment not allowed in this study)
  • History of chronic autoimmune disease (Addison's disease, multiple sclerosis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, ... ) with the exception of patients with active vitiligo or a history of vitiligo
  • History of uveitis and retinopathy associated with melanoma
  • Adults under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous somatic cell therapy

Arm Description

Patients treated with melanoma antigens-specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin.

Outcomes

Primary Outcome Measures

Clinical and biological safety defined by the NCI (Common Toxicity Criteria - Version 4.0, may 2009, http:// ctep.cancer.gov)
Serious adverse effects of grade 3 and 4 will be considered to decide the suspension of inclusion

Secondary Outcome Measures

Progression-free survival
Overall survival
Overall tumor response (complete response, partial response, stable disease) evaluated according to Response Evaluation Criteria in Solid Tumor (RECIST) and immune-related Response Criteria (irRC)
Duration of clinical responses defined as the time interval between the evaluation of the first objective response or stable disease and the first evaluation of disease progression
Persistence of injected specific T cells evaluated by immunomonitoring

Full Information

First Posted
April 3, 2015
Last Updated
January 15, 2020
Sponsor
Nantes University Hospital
Collaborators
UMR892
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1. Study Identification

Unique Protocol Identification Number
NCT02424916
Brief Title
Adoptive Transfer of Specific Melanoma Antigens CD8+ T Cells in Metastatic Melanoma Patients: a Phase I/II Study
Acronym
MelSort
Official Title
Adoptive Transfer of CD8+ T Cells, Sorted With HLA-peptide Multimers and Specific for Melan-A and MELOE-1 Melanoma Antigens, to Metastatic Melanoma Patients. A Phase I/II, Non-randomized, Open Monocentric Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 26, 2015 (Actual)
Primary Completion Date
May 6, 2019 (Actual)
Study Completion Date
May 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
UMR892

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the safety as well as the potential clinical efficacy of an adoptive transfer of CD8+ T cells, sorted with HLA-peptide multimers and specific for Melan-A and MELOE-1 melanoma antigens, to patients suffering from advanced metastatic melanoma (stages IIIc and IV).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
Onco-dermatology, Adoptive transfer, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous somatic cell therapy
Arm Type
Experimental
Arm Description
Patients treated with melanoma antigens-specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin.
Intervention Type
Biological
Intervention Name(s)
Melanoma antigens-specific CD8+ T lymphocytes
Intervention Description
The intervention uses an autologous somatic cell therapy medicinal product. It consists in the intravenous injection of melanoma antigens (Melan-A and MELOE-1) - specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin.
Primary Outcome Measure Information:
Title
Clinical and biological safety defined by the NCI (Common Toxicity Criteria - Version 4.0, may 2009, http:// ctep.cancer.gov)
Description
Serious adverse effects of grade 3 and 4 will be considered to decide the suspension of inclusion
Time Frame
Until disease progression during the follow-up period of the study (12 months)
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
From the date of the first treatment until the date of the first documented progression or the date of death from any cause, whichever came first, assessed up to 2 years
Title
Overall survival
Time Frame
From the date of the first treatment until the date of death, assessed up to 2 years
Title
Overall tumor response (complete response, partial response, stable disease) evaluated according to Response Evaluation Criteria in Solid Tumor (RECIST) and immune-related Response Criteria (irRC)
Time Frame
At 12 months
Title
Duration of clinical responses defined as the time interval between the evaluation of the first objective response or stable disease and the first evaluation of disease progression
Time Frame
At 12 months
Title
Persistence of injected specific T cells evaluated by immunomonitoring
Time Frame
At 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥ 18 and ≤ 75 years Patient expressing the HLA-A*0201 subtype of the human leukocyte antigen (HLA -A2) Patient with metastatic melanoma stage IIIc or IV (AJCC 2010) except brain metastases Tumor expressing the antigens Melan-A and MELOE-1 detected by RT-PCR Absence of cerebral metastases ECOG ≤ 1 or Karnofsky ≥ 80% Prior adjuvant melanoma treatment (before metastatic stage) authorized (anti- BRAF, anti-CTLA4, IFN, TIL... ) Disease measurable / evaluable within 28 days before the first administration of study treatment Negative viral serology (HIV 1/2, Ag p24 , HTLV 1/2 , hepatitis B and C, syphilis) Results of analysis: Hemoglobin ≥ 10 g / dl or ≥ 6.25 mmol / l Leukocytes ≥ 4000/μl Lymphocytes ≥ 1500/μl Platelets ≥ 80.000/μl Creatinine ≤ 2.5 N Total bilirubin ≤ 3 N AST and ALT ≤ 3 N without liver metastases; ≤ 5 N with liver metastases Negative pregnancy test for women of childbearing age Patient affiliated to a social security system Patient who has signed informed consent Exclusion Criteria: Brain metastases Ocular primitive melanoma Treatment of metastatic melanoma by more than two lines (chemotherapy , immunotherapy, targeted therapy or radiotherapy) or within 4 weeks before the inclusion Treatment with ipilimumab within 8 weeks before the inclusion Known allergy to albumin Contraindication to the use of vasopressors Positive viral serology for HIV 1/2 , Ag p24 , HTLV 1/2, hepatitis B or C, or syphilis Women who are pregnant, nursing or refusing to use contraceptives, women with no negative pregnancy test at baseline Presence of a second active cancer (with the exception of cervical cancer in situ or skin cancer other than melanoma) History of event or current event of a progressive or non-stabilized severe heart disease (congestive heart failure, coronary artery disease, uncontrolled hypertension, serious arrhythmias or ECG signs of previous myocardial infarction) Uncontrolled thyroid dysfunction Any serious acute or chronic illness (active infection requiring antibiotics, bleeding disorders or other condition requiring concomitant treatment not allowed in this study) History of chronic autoimmune disease (Addison's disease, multiple sclerosis, Graves' disease, rheumatoid arthritis, systemic lupus erythematosus, ... ) with the exception of patients with active vitiligo or a history of vitiligo History of uveitis and retinopathy associated with melanoma Adults under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Adoptive Transfer of Specific Melanoma Antigens CD8+ T Cells in Metastatic Melanoma Patients: a Phase I/II Study

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