MelanomaPhase 1/2Mel63; CHAMPNCT02425306
Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma
A Phase 1/2 study testing 6MHP, Montanide ISA-51 and polyICLC in people with Melanoma, run by Craig L Slingluff, Jr at 1 site in United States.
Trial summary
This study evaluates whether it is safe to administer a peptide vaccine in combination with different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- 6MHP, Montanide ISA-51 and polyICLC
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2015to 8 Jan 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Part 1 only: Participants with stage IIB, IIC, III, or IV melanoma at original diagnosis or at restaging after recurrence. Patients with high-risk stage IIA melanoma (by DecisionDx Melanoma test, Castle Biosciences, Inc,;Friendswood, TX) also may be eligible. These participants may have had cutaneous, uveal, mucosal primary melanoma, or an unknown primary melanoma. Diagnosis of melanoma must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on version 7 AJCC staging system.
- Part 2 only: Patients with a diagnosis of stage IIIB-IV melanoma with one or more tumor deposits accessible for biopsy and/or excision. These participants may have had cutaneous, uveal, mucosal primary melanoma, or an unknown primary melanoma. Diagnosis of melanoma must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on version 7 AJCC staging system.
- Patients must have adequate cutaneous, subcutaneous, soft tissue, or nodal metastases of melanoma readily accessible for biopsy
- Participants will be required to have radiological studies to rule out radiologically evident disease. Required studies include:
- Chest CT scan,
- Abdominal and pelvic CT scan, and
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- Head CT scan or MRI
- PET/CT fusion scan may replace scans of the chest, abdomen, and pelvis.
- Participants who have had brain metastases will be eligible if all of the following are true:
- Each brain metastasis must have been completely removed by surgery or each unresected brain metastasis must have been treated with stereotactic radiosurgery.
- There has been no evident growth of any brain metastasis since the most recent treatment.
- No brain metastasis is > 2 cm in diameter at the time of registration.
- The most recent surgical resections or gamma-knife therapy for malignant melanoma must have been completed ≥ 1 week and for Part 1, ≤ 6 months prior to registration.
- All participants must have:
- ECOG performance status of 0 or 1 (Appendix 3)
- Ability and willingness to give informed consent
- Laboratory parameters as follows:
- ANC > 1000/mm3
- Platelets > 100,000/mm3
- Hgb > 9 g/dL
- HgbA1c ≤ 7.5%
- Hepatic:
- AST and ALT ≤ 2.5 x upper limits of normal (ULN)
- Bilirubin ≤ 2.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 4x ULN is allowed)
- Alkaline phosphatase ≤ 2.5 x ULN
- Renal
- Creatinine ≤ 1.5 x ULN
- Serology (within 6 months of study entry)
- HIV negative
- Hepatitis C negative (no evidence of active virus)
- Blood is to be collected for HLA typing (Class I and Class II), which will be analyzed as part of the immunologic endpoints, but HLA type will not be an inclusion/exclusion criterion.
- Age 18 years or older at registration.
- Part 1 only: Participants must have at least two intact (undissected) axillary and/or inguinal lymph node basins.
- Part 2 only: Participants must have at least one intact (undissected) axillary and/or inguinal lymph node basin.
Who cannot join
- Participants who have received the following medications or treatments at any time within 4 weeks of registration:
- Chemotherapy
- Interferon (e.g. Intron-A®)
- Radiation therapy (Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week and ≤ 6 months prior to registration)
- Allergy desensitization injections
- High doses of systemic corticosteroids, with the following qualifications and exceptions:
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- In patients with adrenal or pituitary insufficiency replacement steroid doses are allowed; however, daily doses of 10 mg or more of prednisone (or equivalent) per day administered parenterally or orally are not allowed in patients with normal adrenal and pituitary function.
- Inhaled steroids (e.g.: Advair®, Flovent®, Azmacort®) are permitted at low doses (less than 500 mcg fluticasone per day, or equivalent) (76,77).
- Topical, nasal, and intra-articular corticosteroids are acceptable.
- Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
- Interleukins (e.g. Proleukin®)
- Any investigational medication
- Targeted therapies specific for mutated BRAF or for MEK
- Participants who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks
- Participants who are currently receiving a checkpoint molecule blockade therapy, or who have received this therapy within the preceding 12 weeks.
- Participants with known or suspected allergies to any component of the vaccine.
- Participants may not have been vaccinated previously with any of the synthetic peptides included in this protocol. Participants who have received vaccinations containing agents other than the synthetic peptides included in this protocol and have recurred during or after administration of the vaccine will be eligible to enroll 12 weeks following their last vaccination.
- Pregnancy. Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) obtained within 2 weeks prior to registration. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination.
- Female participants must not be breastfeeding
- Participants in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator.
- Participants classified according to the New York Heart Association classification as having Class III or IV heart disease (Appendix 4).
- Participants with uncontrolled diabetes, defined as having a HgbA1c ≥ 7.5%.
- Participants must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. The following will not be exclusionary:
- The presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms
- Clinical evidence of vitiligo
- Other forms of depigmenting illness
- Mild arthritis requiring NSAID medications
- Participants who have another cancer diagnosis, except that the following diagnoses will be allowed:
- squamous cell cancer of the skin without known metastasis
- basal cell cancer of the skin without known metastasis
- carcinoma in situ of the breast (DCIS or LCIS)
- carcinoma in situ of the cervix
- any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 5 years
- Participants with known addiction to alcohol or drugs who are actively taking those agents, or participants with recent (within 1 year) or ongoing illicit IV drug use.
- Body weight < 110 pounds (without clothes) at registration, due to the amount and frequency with which blood will be drawn.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: A Trial to Evaluate the Immunogenicity and Safety of a Melanoma Helper Peptide Vaccine Plus Novel Adjuvant Combinations (MEL63)
This study evaluates whether it is safe to administer a peptide vaccine in combination with different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study will also evaluate the effects of the combination of the peptide vaccine and the adjuvants on the immune system. The investigators will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tissue from the sites of vaccination.
- Conditions
- Melanoma
- Being tested
- 6MHP, Montanide ISA-51, polyICLC, Cyclophosphamide
- Keywords
- peptide, vaccine, adjuvant, polyICLC, cyclophosphamide, Montanide ISA-51
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6MHPBiological
Also called 6 melanoma helper peptide vaccine
6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Montanide ISA-51Drug
Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
polyICLCDrug
polyICLC, local adjuvant
CyclophosphamideDrug
Cyclophosphamide, systemic adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Arm A:6MHP + Montanide ISA-51 | Experimental | Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Receives: Biological: 6MHP; Drug: Montanide ISA-51 |
| Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide | Experimental | Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5) Receives: Biological: 6MHP; Drug: Montanide ISA-51; Drug: Cyclophosphamide |
| Arm C:6MHP + polyICLC + Montanide ISA-51 | Experimental | Part 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Receives: Biological: 6MHP; Drug: Montanide ISA-51; Drug: polyICLC |
| Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide | Experimental | Parts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days:
* Day -6 (Cycle 1)
* Day 8 (Cycle 2)
* Day 22 (Cycle 3)
* Day 36 (Cycle 4)
* Day 50 (Cycle 5) Receives: Biological: 6MHP; Drug: Montanide ISA-51; Drug: polyICLC; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Treatment-related adverse events, by CTCAE v4, Dose-limiting toxicities.
Measured: 30 days after administration of the last dose of 6MHP or cyclophosphamide
Immunogenicity-CD4+ T Cell Responses
CD4+ T cell responses to 6 MHP: durable helper T cell response to 6MHP at 2 or more consecutive timepoints in the PBMC.
Measured: through day 85
Immunogenicity-modification of the Tumor Microenvironment (Part 2 Only)
increased infiltration of CD4+ and CD8+ T lymphocytes into melanoma metastases
Measured: through day 22
Secondary outcomes (1)
Immunogenicity-CD8+ T Cell Responses
CD8+ T cell responses to defined melanoma antigens
Measured: through day 85
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 start12 May 2015
- Primary completion18 Aug 2017
- Study completion8 Jan 2018
Why it stopped: Slow accrual to part 2 of the study. Accrual to part 1 is complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig L Slingluff, Jr
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Institute for Cancer Research, Cancer Research Institute, New York City
- Responsible party
- Sponsor-investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Craig L. Slingluff, Jr., MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425306
- Sponsor's protocol ID
- 17860
- Acronym
- Mel63; CHAMP
- Status last verified
- Oct 2023
- First submitted
- 20 Apr 2015
- Last updated
- 30 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Evaluate the Immunogenicity and Safety of a Melanoma Helper Peptide Vaccine Plus Novel Adjuvant Combinations (MEL63)
- ClinicalTrials.gov ID
- NCT02425306
- Acronym / sponsor ID
- Mel63; CHAMP / 17860
- Conditions
- Melanoma
- Keywords
- peptide, vaccine, adjuvant, polyICLC, cyclophosphamide, Montanide ISA-51
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual to part 2 of the study. Accrual to part 1 is complete.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Craig L Slingluff, JrUniversity, hospital or other
- Collaborators
- Ludwig Institute for Cancer Research, Cancer Research Institute, New York City
- Study start
- 12 May 2015 (actual)
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Posted 29 Apr 2021
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 whether it is safe to administer a peptide vaccine in combination with different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study will also evaluate the effects of the combination of the peptide vaccine and the adjuvants on the immune system. The investigators will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tissue from the sites of vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A:6MHP + Montanide ISA-51 | Experimental | Biological: 6MHP, Drug: Montanide ISA-51Part 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. |
| Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide | Experimental | Biological: 6MHP, Drug: Montanide ISA-51, Drug: CyclophosphamidePart 1: 200 mcg of 6MHP emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days: * Day -6 (Cycle 1) * Day 8 (Cycle 2) * Day 22 (Cycle 3) * Day 36 (Cycle 4) * Day 50 (Cycle 5) |
| Arm C:6MHP + polyICLC + Montanide ISA-51 | Experimental | Biological: 6MHP, Drug: Montanide ISA-51, Drug: polyICLCPart 1: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. |
| Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide | Experimental | Biological: 6MHP, Drug: Montanide ISA-51, Drug: polyICLC, Drug: CyclophosphamideParts 1 and 2: 200 mcg of 6MHP plus 1 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered on 1, 8, 15, 36, 57 and 78. Cyclophosphamide (50 mg) will be taken orally once a day for 7 days followed by a 7 day rest period. This will be repeated for 5 cycles. Cycles will begin on the following days: * Day -6 (Cycle 1) * Day 8 (Cycle 2) * Day 22 (Cycle 3) * Day 36 (Cycle 4) * Day 50 (Cycle 5) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Part 1 only: Participants with stage IIB, IIC, III, or IV melanoma at original diagnosis or at restaging after recurrence. Patients with high-risk stage IIA melanoma (by DecisionDx Melanoma test, Castle Biosciences, Inc,;Friendswood, TX) also may be eligible. These participants may have had cutaneous, uveal, mucosal primary melanoma, or an unknown primary melanoma. Diagnosis of melanoma must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on version 7 AJCC staging system.
- Part 2 only: Patients with a diagnosis of stage IIIB-IV melanoma with one or more tumor deposits accessible for biopsy and/or excision. These participants may have had cutaneous, uveal, mucosal primary melanoma, or an unknown primary melanoma. Diagnosis of melanoma must be confirmed by cytological or histological examination. Staging of cutaneous melanoma will be based on version 7 AJCC staging system.
- Patients must have adequate cutaneous, subcutaneous, soft tissue, or nodal metastases of melanoma readily accessible for biopsy
- Participants will be required to have radiological studies to rule out radiologically evident disease. Required studies include:
- Participants who have had brain metastases will be eligible if all of the following are true:
Key exclusion criteria (35 listed)
- Participants who have received the following medications or treatments at any time within 4 weeks of registration:
- Participants who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks
- Participants who are currently receiving a checkpoint molecule blockade therapy, or who have received this therapy within the preceding 12 weeks.
- Participants with known or suspected allergies to any component of the vaccine.
- Participants may not have been vaccinated previously with any of the synthetic peptides included in this protocol. Participants who have received vaccinations containing agents other than the synthetic peptides included in this protocol and have recurred during or after administration of the vaccine will be eligible to enroll 12 weeks following their last vaccination.
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 |
|---|---|---|
| 6MHPAlso: 6 melanoma helper peptide vaccine6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides | Biological | Arm A:6MHP + Montanide ISA-51, Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide, Arm C:6MHP + polyICLC + Montanide ISA-51, Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide |
| Montanide ISA-51Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant | Drug | Arm A:6MHP + Montanide ISA-51, Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide, Arm C:6MHP + polyICLC + Montanide ISA-51, Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide |
| polyICLCpolyICLC, local adjuvant | Drug | Arm C:6MHP + polyICLC + Montanide ISA-51, Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide |
| CyclophosphamideCyclophosphamide, systemic adjuvant | Drug | Arm B:6MHP + Montanide ISA-51 + Cyclophosphamide, Arm D:6MHP + polyICLC + Montanide ISA-51 + Cyclophosphamide |
Primary outcome
Number of Participants With Adverse Events
Time frame: 30 days after administration of the last dose of 6MHP or cyclophosphamide
Treatment-related adverse events, by CTCAE v4, Dose-limiting toxicities.
Immunogenicity-CD4+ T Cell Responses
Time frame: through day 85
CD4+ T cell responses to 6 MHP: durable helper T cell response to 6MHP at 2 or more consecutive timepoints in the PBMC.
Immunogenicity-modification of the Tumor Microenvironment (Part 2 Only)
Time frame: through day 22
increased infiltration of CD4+ and CD8+ T lymphocytes into melanoma metastases
1 secondary outcome
Immunogenicity-CD8+ T Cell Responses
Time frame: through day 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Craig L. Slingluff, Jr., MD principal investigator
University of Virginia
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 6MHP, Montanide ISA-51 and polyICLC in people with Melanoma, run by Craig L Slingluff, Jr at 1 site in United States.
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 34 inclusion and 35 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 30 Oct 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (time frame: 30 days after administration of the last dose of 6MHP or cyclophosphamide). The study lists 3 primary outcomes in all. 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 30 Oct 2023.