Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02424916
Recruitment Status : Completed
First Posted : April 23, 2015
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
UMR892
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE April 3, 2015
First Posted Date  ICMJE April 23, 2015
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE May 26, 2015
Actual Primary Completion Date May 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
Clinical and biological safety defined by the NCI (Common Toxicity Criteria - Version 4.0, may 2009, http:// ctep.cancer.gov) [ Time Frame: Until disease progression during the follow-up period of the study (12 months) ]
Serious adverse effects of grade 3 and 4 will be considered to decide the suspension of inclusion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2015)
  • 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 ]
  • Overall survival [ Time Frame: From the date of the first treatment until the date of death, assessed up to 2 years ]
  • 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 ]
  • 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 ]
  • Persistence of injected specific T cells evaluated by immunomonitoring [ Time Frame: At 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adoptive Transfer of Specific Melanoma Antigens CD8+ T Cells in Metastatic Melanoma Patients: a Phase I/II Study
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Melanoma
Intervention  ICMJE Biological: Melanoma antigens-specific CD8+ T lymphocytes
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.
Study Arms  ICMJE Experimental: Autologous somatic cell therapy
Patients treated with melanoma antigens-specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin.
Intervention: Biological: Melanoma antigens-specific CD8+ T lymphocytes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2020)
7
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2015)
17
Actual Study Completion Date  ICMJE May 6, 2019
Actual Primary Completion Date May 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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")
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02424916
Other Study ID Numbers  ICMJE RC12_0261
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE UMR892
Investigators  ICMJE Not Provided
PRS Account Nantes University Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP