A Clinical Trial to Evaluate a Melanoma Helper Peptide Vaccine Plus Dabrafenib and Trametinib (Mel61)

  • STATUS
    Recruiting
  • End date
    Dec 12, 2023
  • participants needed
    27
  • sponsor
    Craig L Slingluff, Jr
Updated on 12 July 2022
ct scan
metastatic melanoma
measurable disease
melanoma skin
BRAF
metastasis
brain metastases
peptide vaccine
mek inhibitor
braf inhibitor
trametinib
immunomodulators
dabrafenib
immunologic adjuvant
malignant melanoma of skin

Summary

This study evaluates whether it is safe to administer a helper peptide vaccine with BRAF inhibitor and MEK inhibitor therapy. This study will also evaluate the effects of the combination of the peptide vaccine and BRAF inhibitors/MEK inhibitors on the immune system. We will monitor these effects by performing tests in the laboratory on participants' blood and tumor samples.

Details
Condition Melanoma
Treatment 6MHP, Dabrafenib, Trametinib, MEK inhibitor, BRAF inhibitor
Clinical Study IdentifierNCT02382549
SponsorCraig L Slingluff, Jr
Last Modified on12 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Cohort 1 (Advanced): Measurable stage IIIB, IIIC, IIID or IV melanoma with clinical or
radiological evidence of disease. These participants may have had cutaneous, uveal, mucosal
primary melanoma, or an unknown primary melanoma. Staging must be confirmed by cytological
or histological examination. Staging of cutaneous melanoma will be based on the revised
AJCC 8th Edition staging system (Appendix 2) 66
Cohort 2 (Neo-adjuvant): Resectable stage IIIB, IIIC, IIID, or IV melanoma at initial
presentation or subsequent recurrence. These participants have disease amenable to complete
surgical resection at the time of enrollment in the study. The resectable disease does not
need to be measurable by RECIST v1.1 criteria
Cohort 3 (Adjuvant): Participants with stage IIIA, IIIB, IIIC, IIID or IV melanoma resected
to no evidence of disease. Participants must initiate therapy within 12 weeks of last
surgical resection and within 12 weeks of being rendered clinically free of disease by
non-surgical approaches Patients that have undergone ablative therapy to a metastatic
lesion (e.g. GKRS, radiofrequency ablation) that manifest no additional sites of disease at
Participants must be eligible to be treated with BRAF inhibitor and MEK inhibitor
combination
enrollment are eligible for treatment on cohort 3
Participants with prior therapy with targeted therapies specific for mutated BRAF
including BRAF and/or MEK inhibitors are eligible provided that there was clinical
benefit to prior therapy with these agents as judged by the treating physician. There
must be an interval of at least 6 months from the last BRAF/MEK therapy and enrollment
Chest CT scan
in this clinical study
Abdominal and pelvic CT scan, and
Participants will be required to have radiological studies at baseline to establish
Head CT scan or MRI
measurable disease for cohort 1 or to prove lack of distant metastases for cohorts 2
and 3. Required studies include
No brain metastasis is > 2 cm in diameter at the time of registration
Participants in cohorst 1 & 2 who have metastatic melanoma safely available for biopsy
Neurologic symptoms have returned to baseline off steroids
pretreatment and on day 22 must consent to having those biopsies. These metastases may
Subjects are not using steroids for at least 7 days prior to registration
be in nodes, skin, soft tissue, liver, or other sites that can be accessed by needle
biopsy, incisional or excisional biopsy, with or without image guidance
ECOG performance status of 0-2
1.6 Participants who have had brain metastases will be eligible if all of the
Participants must have the ability and willingness to give informed consent
following are true
Laboratory parameters as follows
Each brain metastasis must have been completely removed by surgery or each
ANC > 1000/mm3
unresected brain metastasis must have been treated with stereotactic radiosurgery
Platelets > 100,000/mm3
or systemic immunotherapy
Hgb > 9 g/dL
There has been no evident growth of any brain metastasis since the most recent
treatment if the last treatment is >4 weeks prior to enrollment
Bilirubin up to 2.5 x ULN
Alkaline phosphatase up to 2.5 x ULN
Creatinine up to 1.5 x ULN
The most recent surgical resections or gamma-knife therapy for malignant melanoma
Age 18 years or older at registration
must have been completed ≥ 1 week prior to registration
HgB-A1c ≤ 8.5%
AST and ALT up to 2.5 x upper limits of normal (ULN). Patients known to have
Gilbert's disease may be eligible with AST and ALT up to 5 x ULN
Participants must have at least two intact (undissected) axillary and/or inguinal
lymph node basins

Exclusion Criteria

Allergy desensitization injections
Any investigational medication
HIV positivity or evidence of active Hepatitis C virus
Participants with known or suspected allergies to any component of the vaccine
Pregnancy
Participants who have received the following medications or treatments at any time
Female participants must not be breastfeeding
within 4 weeks of registration
• Chemotherapy
Interferon (e.g. Intron-A®)
Radiation therapy (Stereotactic radiotherapy, such as gamma knife, can be used ≥
week and ≤ 6 months prior to registration)
squamous cell cancer of the skin without known metastasis
Corticosteroids, administered transdermally, parenterally or orally. Inhaled
basal cell cancer of the skin without known metastasis
steroids (e.g.: Advair®, Flovent®, Azmacort®) are not permitted. Topical
carcinoma in situ of the breast (DCIS or LCIS)
corticosteroids are acceptable
carcinoma in situ of the cervix
Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
Interleukins (e.g. Proleukin®)
Body weight < 110 pounds
Participants with a known history of glucose-6-phosphate dehydrogenase deficiency
Participants who are currently receiving nitrosoureas or who have received this
therapy 6 weeks prior to registration
Participants who are currently receiving a checkpoint molecule blockade therapy, or
who have received this therapy within 3weeks prior to registration
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
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
Participants with uncontrolled diabetes, defined as having a HgB-A1c greater than
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
Participants who have another cancer diagnosis, except that the following diagnoses
will be allowed
any cancer without distant metastasis that has been treated successfully, without
evidence of recurrence or metastasis for over 3 years
Participants with known addiction to alcohol or drugs who are actively taking those
agents, or participants with recent (within 1 year of registration) or ongoing illicit
IV drug use
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