Malignant Melanoma With MetastasisPhase 1NCT02077114
Vaccination With Peptides in Combination With Either Ipilimumab or Vemurafenib for the Treatment of Unresectable Stage III or IV Malignant Melanoma
A Phase 1 study testing Vaccine consisting of a peptide derived from the protein IDO in people with Malignant Melanoma With Metastasis, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to assess whether a vaccine containing a small fragment of the protein IDO, which may be present in cancer cells and cells of the immune system, is safe to use in combination with either Ipilimumab or Vemurafenib in the treatment of malignant melanoma that has metastasized. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Melanoma With Metastasis
- What is being tested?
- Vaccine consisting of a peptide derived from the protein IDO
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Sep 2014
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Measurable disease according to RECIST 1.1
- ECOG performance status ≤ 2
- Patients with asymptomatic brain metastases allowed (treatment with systemic glucocorticoids is not compatible with participation)
- Women of childbearing potential must have negative s-hCG prior to initiation of treatment, and use effective contraception during treatment and up to 26 weeks after the last treatment. Safe contraception include: Birth control pills, intrauterine devices, depot injection of progesterone, subdermal implantation (eg Implanon), hormonal vaginal ring and transdermal patch.
- All patients must meet all inclusion criteria in the treatment group they belong to.
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- Histologic confirmed stage III (non-operable) or stage IV melanoma with BRAF V600 documented mutation
- Patients should be fully recovered from any previous systemic or topical treatment for metastatic malignant melanoma
- Adequate haematological, renal and hepatic function:
- Neutrophils ≥ 1.5 x 10^9 / l
- Platelet count ≥ 100 x 10^9 / l
- Hemoglobin ≥ 5.6 mmol / l
- Serum creatinine ≤ 1.5 times upper normal limit
- AST or ALT ≤ 2.5 times upper normal limit (≤ 5 times upper normal limit if it is considered that an increase due to liver metastases)
- Serum bilirubin ≤ 1.5 times upper normal limit
- Alkaline phosphatase ≤ 2.5 times upper normal limit (≤ 5 times upper normal limit if it is considered that an increase due to liver metastases)
- Histologic verified stage III (non-operable) or stage IV malignant melanoma
- Patients previously treated with anti-CTLA-4 therapy can be included, unless this treatment is stopped due to lack of efficacy or side effects
- There must be at least 21 days since last systemic treatment of malignant melanoma and the patient must be free of side effects from this treatment. After palliative radiotherapy elsewhere than in the brain, treatment with Ipilimumab and peptide vaccine can be initiated, without a 21 day break. When radiotherapy is used for brain metastases, treatment, however, can only be initiated when the patient is not dependent on prednisolone.
- Adequate haematological, renal and hepatic function:
- Leukocytes ≥ 2 x 10^9 / l
- Neutrophils ≥ 1 x 10^9 / l
- Platelet count ≥ 75 x 10^9 / l
- Hemoglobin ≥ 5.6 mmol / l (possibly after transfusion)
- Serum creatinine ≤ 2 times upper limit of normal
- AST or ALT ≤ 2.5 times upper normal limit (≤ 5 times upper normal limit if it is considered that an increase due to liver metastases)
- Serum bilirubin ≤ 2 times upper normal limit (except for patients with Gilbert's syndrome, which allowed bilirubin up to 3.0 mg / dL)
Who cannot join
- Concomitant immunosuppressive therapy including prednisolone and methotrexate
- Known infection with HIV, hepatitis B and C virus, even if infection remain stable with medical treatment
- Other malignancy within the past three years, other than squamous cell and basal cell skin carcinoma
- Serious somatic disease, severe asthma, severe COPD, poorly controlled cardiovascular disease or diabetes
- Patients must not have undergone major intestinal surgery within the last 28 days.
- Severe allergies or previous anaphylactoid reactions
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- Pregnant or lactating women
- Psychiatric illness that is perceived by the investigator to likely affect patient compliance
- Known hypersensitivity to ingredients in the adjuvant substances Montanide or Aldara cream
- At least one of the following within the past six months: myocardial infarction, severe / unstable angina pectoris, symptomatic congestive heart failure, cerebrovascular event or transient ischaemic attack, pulmonary embolism, poorly controlled hypertension,
- Congenital long QT syndrome, previous or current significant ventricular or atrial dysrhythmia ≥ 2nd degree (NCI CTCAE version 4.0)
- Corrected QT interval ≥ 450 msec at baseline
- Uncontrolled medical illness such as infection requiring intravenous antibiotics
- Other severe acute, chronic or psychiatric condition or abnormal laboratory value, which can increase the risk associated with Vemurafenib treatment
- Autoimmune diseases: History of inflammatory bowel disease, including Crohn's disease and ulcerative colitis, systemic autoimmune disease eg. rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis, including Wegener granulomatosis. Patients with motor neuropathy believed to be of autoimmune origin such as Guillain-Barre and Myasthenia gravis can not be included in the study.
- Treatment with any vaccine to prevent infection within 28 prior to initiation of treatment with the peptide vaccine and Ipilimumab
- Systemic treatment with prednisolone.
- Life-threatening diseases that require treatment with immunosuppressive agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peptide Vaccination in Combination With Either Ipilimumab or Vemurafenib for the Treatment of Patients With Unresectable Stage III or IV Malignant Melanoma A Phase I Study (First in Man)
The purpose of the study is to assess whether a vaccine containing a small fragment of the protein IDO, which may be present in cancer cells and cells of the immune system, is safe to use in combination with either Ipilimumab or Vemurafenib in the treatment of malignant melanoma that has metastasized.
- Conditions
- Malignant Melanoma With Metastasis
- Being tested
- Vaccine consisting of a peptide derived from the protein IDO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine consisting of a peptide derived from the protein IDOBiological
Also called IDOlong
All patients will receive seven vaccines containing IDOlong
| Study group | Role | What they receive |
|---|---|---|
| Ipilimumab | Experimental | Patient who according to standard criteria are candidates to treatment with Ipilimumab Receives: Biological: Vaccine consisting of a peptide derived from the protein IDO |
| Vemurafenib | Experimental | Patients who according to standard criteria are candidates to treatment with Vemurafenib Receives: Biological: Vaccine consisting of a peptide derived from the protein IDO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events during and after treatment as a Measure of Safety and Tolerability.
Primary endpoints will be assessed according to CTCAE ver. 4.0
Measured: Ipilimumab+vaccine combination: Day 84. Vemurafenib+vaccine combination: Day 56.
Secondary outcomes (1)
Vaccine related immune response
Reactivity towards epitopes nested within the sequence of the peptide used for vaccination, will be assessed in T cells from peripheral blood, obtained at the specified sample times. Reactivity will be assessed using ELISpot technology, where secretion of interferon gamma and tumor necrosis factor alpha is measured during in vitro stimulation with the peptide used for vaccination. In addition to this, combinatorial coding with fluor chrome conjugated HLA tetramers are used to enumerate precursor frequency of CD8 T cells specific for epitopes within the peptide sequence
Measured: Ipilimumab: Day 1 (before first treatnent), day 21, day 42, day 63 and at day 84. Thereafter every 12 weeks until progression or up to 104 weeks. Vemurafenib: Day 1, day 28, day 56. Thereafter every 28 days until progression or up to week 104 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Melanoma With MetastasisStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Bjørn, Herlev Hospital
- Investigators
- Jon Bjørn, MD, Principal investigator, Center for Cancer Immune TherapyInge Marie Svane, MD, PhD, Professor, Study chair, Center for Cancer Immune Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077114
- Sponsor's protocol ID
- MM1304
- Status last verified
- Sep 2014
- First submitted
- 20 Feb 2014
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peptide Vaccination in Combination With Either Ipilimumab or Vemurafenib for the Treatment of Patients With Unresectable Stage III or IV Malignant Melanoma A Phase I Study (First in Man)
- ClinicalTrials.gov ID
- NCT02077114
- Acronym / sponsor ID
- MM1304
- Conditions
- Malignant Melanoma With Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- First posted
- 4 Mar 2014 (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.
The purpose of the study is to assess whether a vaccine containing a small fragment of the protein IDO, which may be present in cancer cells and cells of the immune system, is safe to use in combination with either Ipilimumab or Vemurafenib in the treatment of malignant melanoma that has metastasized.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipilimumab | Experimental | Biological: Vaccine consisting of a peptide derived from the protein IDOPatient who according to standard criteria are candidates to treatment with Ipilimumab |
| Vemurafenib | Experimental | Biological: Vaccine consisting of a peptide derived from the protein IDOPatients who according to standard criteria are candidates to treatment with Vemurafenib |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- All patients must meet all inclusion criteria in the treatment group they belong to.
- Histologic confirmed stage III (non-operable) or stage IV melanoma with BRAF V600 documented mutation
- Patients should be fully recovered from any previous systemic or topical treatment for metastatic malignant melanoma
- Adequate haematological, renal and hepatic function:
- Histologic verified stage III (non-operable) or stage IV malignant melanoma
Key exclusion criteria (18 listed)
- At least one of the following within the past six months: myocardial infarction, severe / unstable angina pectoris, symptomatic congestive heart failure, cerebrovascular event or transient ischaemic attack, pulmonary embolism, poorly controlled hypertension,
- Congenital long QT syndrome, previous or current significant ventricular or atrial dysrhythmia ≥ 2nd degree (NCI CTCAE version 4.0)
- Corrected QT interval ≥ 450 msec at baseline
- Uncontrolled medical illness such as infection requiring intravenous antibiotics
- Other severe acute, chronic or psychiatric condition or abnormal laboratory value, which can increase the risk associated with Vemurafenib treatment
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 |
|---|---|---|
| Vaccine consisting of a peptide derived from the protein IDOAlso: IDOlongAll patients will receive seven vaccines containing IDOlong | Biological | Ipilimumab, Vemurafenib |
Primary outcome
Number of Participants with Adverse Events during and after treatment as a Measure of Safety and Tolerability.
Time frame: Ipilimumab+vaccine combination: Day 84. Vemurafenib+vaccine combination: Day 56.
Primary endpoints will be assessed according to CTCAE ver. 4.0
1 secondary outcome
Vaccine related immune response
Time frame: Ipilimumab: Day 1 (before first treatnent), day 21, day 42, day 63 and at day 84. Thereafter every 12 weeks until progression or up to 104 weeks. Vemurafenib: Day 1, day 28, day 56. Thereafter every 28 days until progression or up to week 104 weeks.
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 26 Sep 2014.
- Related InfoLink provided by the sponsor.
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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.
Jon Bjørn, MD principal investigator
Center for Cancer Immune Therapy
Inge Marie Svane, MD, PhD, Professor study chair
Center for Cancer Immune Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vaccine consisting of a peptide derived from the protein IDO in people with Malignant Melanoma With Metastasis, run by Herlev Hospital at 1 site in Denmark.
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 27 inclusion and 18 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 26 Sep 2014. 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 Denmark. 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 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.
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?
Number of Participants with Adverse Events during and after treatment as a Measure of Safety and Tolerability. (time frame: Ipilimumab+vaccine combination: Day 84. Vemurafenib+vaccine combination: Day 56.). 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 26 Sep 2014.