MelanomaPhase 1/2NCT00365937
Immunization of Disease-Free Melanoma Patients With Different HLA-A2 Peptides
A Phase 1/2 study testing Immunological peptides and immunological adjuvants, HLA-A2 peptides and Montanide ISA51 in people with Melanoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Open-label single center study. Patients will be divided in four groups of 7. Group 1: 8 melanoma-specific peptides in saline; Group 2: same mix of peptides + Montanide ISA51; Group 3: same mix of peptides + IMP321 500 µg; Group 4: same mix of peptides + IMP321 500 µg + Montanide ISA51. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Immunological peptides and immunological adjuvants, HLA-A2 peptides and Montanide ISA51
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2006to 13 Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven cutaneous melanoma.
- Patient's melanoma must be in one of the following AJCC stages :
- only primary tumor : T3b-T4, N0, M0. regional lymph node metastasis and/or in-transit metastasis, no distant metastasis (any T, N1-N3, M0) that has been removed.
- Any distant metastasis that has been removed (M1) HLA-A2 positive. Patients with previous regional metastatic disease must have one of their resected lesions analyzed by RT-PCR to determine expression of genes MAGE-1, MAGE-3, MAGE-4, MAGE-10, MAGE-C2, NA17, Tyrosinase or NY-ESO-1. However, expression of these genes by the tumor is not required to enter the study.
- Absence of detectable melanoma lesions. WHO/ECOG performance status of 1 or less (Karnofsky scale ≥ 70%).
- The following laboratory results:
- Hemoglobin ≥ 10 g/dl; Neutrophils ≥ 1,500/µl; Lymphocytes ≥ 700/µl; Platelets ≥ 100,000/µl; Serum creatinin ≤ 2.0 mg/dl; Serum bilirubin ≤ 2.0 mg/dl; LDH within normal institutional limits.
- Age > 18 years. Able to give written informed consent.
Who cannot join
- Clinically significant heart disease (NYHA Class III or IV). Other serious illnesses, e.g. serious infections requiring antibiotics, bleeding disorders, a second active malignancy, except basal cell carcinoma or in situ carcinoma of the uterine cervix.
- Active immunodeficiency disease or autoimmune disease. Positive serology for HIV (human immunodeficiency virus) or HCV (hepatitis C virus). Serum hepatitis B antigen (HBsAg) must be negative.
- More than one line of previous chemotherapy, or immunotherapy for the melanoma. Previous vaccination with one of the antigen present in the vaccine. Treatment with steroids or major immunosuppressive drugs within 4 weeks before study entry. Topical or inhalational steroids are permitted.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Pregnancy or lactation. Women of childbearing potential not using a medically acceptable means of contraception.
- Psychiatric or addictive disorders that may compromise the ability to give informed consent.
- Lack of availability of the patient for immunological and clinical follow-up assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Open-label single center study. Patients will be divided in four groups of 7. Group 1: 8 melanoma-specific peptides in saline; Group 2: same mix of peptides + Montanide ISA51; Group 3: same mix of peptides + IMP321 500 µg; Group 4: same mix of peptides + IMP321 500 µg + Montanide ISA51. These vaccines will be administered every 3 weeks on 5 occasions by intradermal and superficial subcutaneous injections.
Read the detailed description
Open-label single center study. Patients will be divided in four groups of 7. The patients will be entered sequentially at the time they present in clinic, and randomized in one of the four groups.
The first group of patients will receive a dose of 300 µg of each of the MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2, NA17.A2, Tyrosinase.A2 and NY-ESO-1.A2 peptides without adjuvant. The peptides will be mixed together and administered by intradermal and superficial subcutaneous injections at two sites every three weeks on 5 occasions (3 months).
The second group of patients will receive on 5 occasions a vaccine containing the same 8 peptides mixed together but emulsified in 1 ml of Montanide ISA51. This vaccine will be also administered by intradermal and subcutaneous injections every three weeks.
The third cohort of patients will receive at 3 weeks-interval on 5 occasions the mix of 8 peptides and 500 µg of IMP321. These two injections will be done at the same site, first adjuvant IMP321 then the peptides.
The last seven patients will receive as vaccine the same mix of peptides emulsified with Montanide ISA 51 VG and IMP321 injected with the same procedure as cohort 3. These vaccines will be administrated every 3 weeks on 5 occasions by intradermal and superficial subcutaneous injections.
Blood samples will be obtained from a buffy-coat at weeks 1 and 16. PBL collected at baseline (day 1) and at week 16 will be tested to determine whether a specific CTL response, defined as a 10-times or more increase in CTL frequency, occurred.
For the patients with an anti-vaccine lymphocyte response, 100 ml of blood will be collected every three months in order to monitor their immune response. If a decrease in CTL frequency by a factor 10 is observed, the patients will be revaccinated three times at three weeks interval with the peptide(s) against which he developed an immune response mixed with the adjuvant he already received.
The disease status will be assessed at study entry and thereafter every 3 months during one year. At any time, relapse will result in withdrawal of the patient from the trial.
- Conditions
- Melanoma
- Being tested
- Immunological peptides and immunological adjuvants, HLA-A2 peptides, Montanide ISA51, IMP321
- Keywords
- immunotherapy, adjuvants, IMP321, Montanide ISA51 VG, tumor-specific peptides
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunological peptides and immunological adjuvantsBiological
HLA-A2 peptidesBiological
Tyrosinase.A2: lyophilized powder, 326 mcg, 5 injections every 3 weeks MAGE-C2.A2: lyophilized powder, 320 mcg, 5 injections every 3 weeks NY-ESO-1b.A2: lyophilized powder, 290 mcg, 5 injections every 3 weeks MAGE-4.A2: lyophilized powder, 299 mcg, 5 injections every 3 weeks MAGE-3.A2: lyophilized powder, 300 mcg, 5 injections every 3 weeks MAGE-1.A2: lyophilized powder, 298 mcg, 5 injections every 3 weeks NA17.A2 (GnTV): lyophilized powder, 300 mcg, 5 injections every 3 weeks MAGE-10.A2: lyophilized powder, 309 mcg, 5 injections every 3 weeks
Montanide ISA51Biological
Oil emulsion (W/O: droplet test S57 IN 001), conductivity less than 10mcs.cm-1, viscosity: 1500 mPas (brookfield DVI - spindle 2- Speed 30). For human applications. Injected 5 times every 3 weeks.
IMP321Biological
Official name of the LAG-3 molecule is CD223. Chemical structure: hLAG-3Ig is a soluble human recombinant LAG-3 protein comprising the extra-cellular Ig-like domains.
The IMP321 drug product is composed of a soluble recombinant protein at a 1.18 mg/ml concentration, in PBS (Na2HPO4 2H2O 8.1mM, KH2PO4 1.47mM, NaCl 137mM, KCl 2.68mM, PH 7.2). Batch number: S017/LC1/041011.IMP321 will be provided in 250mcl aliquots in brosilicate siliconized vials.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The eight HLA-A2 peptides Receives: Biological: Immunological peptides and immunological adjuvants; Biological: HLA-A2 peptides |
| Group B | Experimental | The eight HLA-A2 peptides + immunological adjuvant Montanide ISA51 Receives: Biological: Immunological peptides and immunological adjuvants; Biological: HLA-A2 peptides; Biological: Montanide ISA51 |
| Group C | Experimental | the eight peptides HLA-A2 + IMP321 Receives: Biological: Immunological peptides and immunological adjuvants; Biological: HLA-A2 peptides; Biological: IMP321 |
| Group D | Experimental | The eight HLA-A2 peptides + the 2 immunological adjuvants (Montanides ISA 51 and IMP321) Receives: Biological: Immunological peptides and immunological adjuvants; Biological: HLA-A2 peptides; Biological: Montanide ISA51; Biological: IMP321 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: Determination of the cytolytic T lymphocyte response in the different arms.; Toxicity of the combination peptide and immunological adjuvants
Secondary outcomes (1)
Secondary: Disease-free survival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startAug 2006
- Primary completion13 Dec 2013
- Study completion13 Dec 2013
Why it stopped: New regulatories of the peptides by the pharmaceutical company (the seller)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Immutep S.A.S.
- Responsible party
- Sponsor
- Investigators
- Jean-François Baurain, M.D, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365937
- Sponsor's protocol ID
- LUC 05-003
- Status last verified
- Mar 2019
- First submitted
- 17 Aug 2006
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunization of Disease-Free Melanoma Patients With Different HLA-A2 Peptides
- ClinicalTrials.gov ID
- NCT00365937
- Acronym / sponsor ID
- LUC 05-003
- Conditions
- Melanoma
- Keywords
- immunotherapy, adjuvants, IMP321, Montanide ISA51 VG, tumor-specific peptides
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New regulatories of the peptides by the pharmaceutical company (the seller)
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Immutep S.A.S.
- Study start
- Aug 2006 (actual)
- Primary completion
- 13 Dec 2013 (actual)
- Study completion
- 13 Dec 2013 (actual)
- First posted
- 18 Aug 2006 (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.
Open-label single center study. Patients will be divided in four groups of 7. Group 1: 8 melanoma-specific peptides in saline; Group 2: same mix of peptides + Montanide ISA51; Group 3: same mix of peptides + IMP321 500 µg; Group 4: same mix of peptides + IMP321 500 µg + Montanide ISA51. These vaccines will be administered every 3 weeks on 5 occasions by intradermal and superficial subcutaneous injections.
Detailed description
Open-label single center study. Patients will be divided in four groups of 7. The patients will be entered sequentially at the time they present in clinic, and randomized in one of the four groups.
The first group of patients will receive a dose of 300 µg of each of the MAGE-1.A2, MAGE-3.A2, MAGE-4.A2, MAGE-10.A2, MAGE-C2.A2, NA17.A2, Tyrosinase.A2 and NY-ESO-1.A2 peptides without adjuvant. The peptides will be mixed together and administered by intradermal and superficial subcutaneous injections at two sites every three weeks on 5 occasions (3 months).
The second group of patients will receive on 5 occasions a vaccine containing the same 8 peptides mixed together but emulsified in 1 ml of Montanide ISA51. This vaccine will be also administered by intradermal and subcutaneous injections every three weeks.
The third cohort of patients will receive at 3 weeks-interval on 5 occasions the mix of 8 peptides and 500 µg of IMP321. These two injections will be done at the same site, first adjuvant IMP321 then the peptides.
The last seven patients will receive as vaccine the same mix of peptides emulsified with Montanide ISA 51 VG and IMP321 injected with the same procedure as cohort 3. These vaccines will be administrated every 3 weeks on 5 occasions by intradermal and superficial subcutaneous injections.
Blood samples will be obtained from a buffy-coat at weeks 1 and 16. PBL collected at baseline (day 1) and at week 16 will be tested to determine whether a specific CTL response, defined as a 10-times or more increase in CTL frequency, occurred.
For the patients with an anti-vaccine lymphocyte response, 100 ml of blood will be collected every three months in order to monitor their immune response. If a decrease in CTL frequency by a factor 10 is observed, the patients will be revaccinated three times at three weeks interval with the peptide(s) against which he developed an immune response mixed with the adjuvant he already received.
The disease status will be assessed at study entry and thereafter every 3 months during one year. At any time, relapse will result in withdrawal of the patient from the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Immunological peptides and immunological adjuvants, Biological: HLA-A2 peptidesThe eight HLA-A2 peptides |
| Group B | Experimental | Biological: Immunological peptides and immunological adjuvants, Biological: HLA-A2 peptides, Biological: Montanide ISA51The eight HLA-A2 peptides + immunological adjuvant Montanide ISA51 |
| Group C | Experimental | Biological: Immunological peptides and immunological adjuvants, Biological: HLA-A2 peptides, Biological: IMP321the eight peptides HLA-A2 + IMP321 |
| Group D | Experimental | Biological: Immunological peptides and immunological adjuvants, Biological: HLA-A2 peptides, Biological: Montanide ISA51, Biological: IMP321The eight HLA-A2 peptides + the 2 immunological adjuvants (Montanides ISA 51 and IMP321) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically proven cutaneous melanoma.
- only primary tumor : T3b-T4, N0, M0. regional lymph node metastasis and/or in-transit metastasis, no distant metastasis (any T, N1-N3, M0) that has been removed.
- Any distant metastasis that has been removed (M1) HLA-A2 positive. Patients with previous regional metastatic disease must have one of their resected lesions analyzed by RT-PCR to determine expression of genes MAGE-1, MAGE-3, MAGE-4, MAGE-10, MAGE-C2, NA17, Tyrosinase or NY-ESO-1. However, expression of these genes by the tumor is not required to enter the study.
- Absence of detectable melanoma lesions. WHO/ECOG performance status of 1 or less (Karnofsky scale ≥ 70%).
- Hemoglobin ≥ 10 g/dl; Neutrophils ≥ 1,500/µl; Lymphocytes ≥ 700/µl; Platelets ≥ 100,000/µl; Serum creatinin ≤ 2.0 mg/dl; Serum bilirubin ≤ 2.0 mg/dl; LDH within normal institutional limits.
Key exclusion criteria (7 listed)
- Clinically significant heart disease (NYHA Class III or IV). Other serious illnesses, e.g. serious infections requiring antibiotics, bleeding disorders, a second active malignancy, except basal cell carcinoma or in situ carcinoma of the uterine cervix.
- Active immunodeficiency disease or autoimmune disease. Positive serology for HIV (human immunodeficiency virus) or HCV (hepatitis C virus). Serum hepatitis B antigen (HBsAg) must be negative.
- More than one line of previous chemotherapy, or immunotherapy for the melanoma. Previous vaccination with one of the antigen present in the vaccine. Treatment with steroids or major immunosuppressive drugs within 4 weeks before study entry. Topical or inhalational steroids are permitted.
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
- Pregnancy or lactation. Women of childbearing potential not using a medically acceptable means of contraception.
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 |
|---|---|---|
| Immunological peptides and immunological adjuvants | Biological | Group A, Group B, Group C, Group D |
| HLA-A2 peptidesTyrosinase.A2: lyophilized powder, 326 mcg, 5 injections every 3 weeks MAGE-C2.A2: lyophilized powder, 320 mcg, 5 injections every 3 weeks NY-ESO-1b.A2: lyophilized powder, 290 mcg, 5 injections every 3 weeks MAGE-4.A2: lyophilized powder, 299 mcg, 5 injections every 3 weeks MAGE-3.A2: lyophilized powder, 300 mcg, 5 injections every 3 weeks MAGE-1.A2: lyophilized powder, 298 mcg, 5 injections every 3 weeks NA17.A2 (GnTV): lyophilized powder, 300 mcg, 5 injections every 3 weeks MAGE-10.A2: lyophilized powder, 309 mcg, 5 injections every 3 weeks | Biological | Group A, Group B, Group C, Group D |
| Montanide ISA51Oil emulsion (W/O: droplet test S57 IN 001), conductivity less than 10mcs.cm-1, viscosity: 1500 mPas (brookfield DVI - spindle 2- Speed 30). For human applications. Injected 5 times every 3 weeks. | Biological | Group B, Group D |
| IMP321Official name of the LAG-3 molecule is CD223. Chemical structure: hLAG-3Ig is a soluble human recombinant LAG-3 protein comprising the extra-cellular Ig-like domains. The IMP321 drug product is composed of a soluble recombinant protein at a 1.18 mg/ml concentration, in PBS (Na2HPO4 2H2O 8.1mM, KH2PO4 1.47mM, NaCl 137mM, KCl 2.68mM, PH 7.2). Batch number: S017/LC1/041011.IMP321 will be provided in 250mcl aliquots in brosilicate siliconized vials. | Biological | Group C, Group D |
Primary outcome
Primary: Determination of the cytolytic T lymphocyte response in the different arms.; Toxicity of the combination peptide and immunological adjuvants
1 secondary outcome
Secondary: Disease-free survival.
Results and safety
The study was stopped early (reason given: New regulatories of the peptides by the pharmaceutical company (the seller)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
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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.
Jean-François Baurain, M.D, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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 Immunological peptides and immunological adjuvants, HLA-A2 peptides and Montanide ISA51 in people with Melanoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 Mar 2019. 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 Belgium. 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 was stopped early (reason given: New regulatories of the peptides by the pharmaceutical company (the seller)). Results are not available in the source record.
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?
Primary: Determination of the cytolytic T lymphocyte response in the different arms.; Toxicity of the combination peptide and immunological adjuvants. 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 6 Mar 2019.