Metastatic MelanomaPhase 1/2MelSortNCT02424916
Adoptive Transfer of Specific Melanoma Antigens CD8+ T Cells in Metastatic Melanoma Patients: a Phase I/II Study
A Phase 1/2 study testing Melanoma antigens-specific CD8+ T lymphocytes in people with Metastatic Melanoma, run by Nantes University Hospital at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Melanoma antigens-specific CD8+ T lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 26 May 2015to 6 May 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- 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
Who cannot join
- 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
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- 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")
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Metastatic Melanoma
- Being tested
- Melanoma antigens-specific CD8+ T lymphocytes
- Keywords
- Onco-dermatology, Adoptive transfer, Immunotherapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melanoma antigens-specific CD8+ T lymphocytesBiological
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 group | Role | What they receive |
|---|---|---|
| Autologous somatic cell therapy | Experimental | Patients treated with melanoma antigens-specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin. Receives: Biological: Melanoma antigens-specific CD8+ T lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Until disease progression during the follow-up period of the study (12 months)
Secondary outcomes (5)
Progression-free survival
Measured: 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
Measured: 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)
Measured: 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
Measured: At 12 months
Persistence of injected specific T cells evaluated by immunomonitoring
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study start26 May 2015
- Primary completion6 May 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- UMR892
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424916
- Sponsor's protocol ID
- RC12_0261
- Acronym
- MelSort
- Status last verified
- Jan 2020
- First submitted
- 3 Apr 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02424916
- Acronym / sponsor ID
- MelSort / RC12_0261
- Conditions
- Metastatic Melanoma
- Keywords
- Onco-dermatology, Adoptive transfer, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- UMR892
- Study start
- 26 May 2015 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous somatic cell therapy | Experimental | Biological: Melanoma antigens-specific CD8+ T lymphocytesPatients treated with melanoma antigens-specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melanoma antigens-specific CD8+ T lymphocytesThe 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. | Biological | Autologous somatic cell therapy |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Melanoma antigens-specific CD8+ T lymphocytes in people with Metastatic Melanoma, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.