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

  • STATUS
    Recruiting
  • End date
    Jun 3, 2023
  • participants needed
    27
  • sponsor
    Craig L Slingluff, Jr
Updated on 23 February 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 dabrafenib and trametinib. This study will also evaluate the effects of the combination of the peptide vaccine and dabrafenib and trametinib 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
Clinical Study IdentifierNCT02382549
SponsorCraig L Slingluff, Jr
Last Modified on23 February 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
enrollment are eligible for treatment on cohort 3
Participants must be eligible to be treated with BRAF inhibitor and MEK inhibitor combination
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 in this clinical study
Participants will be required to have radiological studies at baseline to establish measurable disease for cohort 1 or to prove lack of distant metastases for cohorts 2 and 3. Required studies include
Chest CT scan
Abdominal and pelvic CT scan, and
Head CT scan or MRI
Participants in cohorst 1 & 2 who have metastatic melanoma safely available for biopsy pretreatment and on day 22 must consent to having those biopsies. These metastases may 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
1.6 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 or systemic immunotherapy
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
No brain metastasis is > 2 cm in diameter at the time of registration
Neurologic symptoms have returned to baseline off steroids
Subjects are not using steroids for at least 7 days prior to registration
The most recent surgical resections or gamma-knife therapy for malignant melanoma must have been completed 1 week prior to registration
ECOG performance status of 0-2
Participants must have the ability and willingness to give informed consent
Laboratory parameters as follows
ANC > 1000/mm3
Platelets > 100,000/mm3
Hgb > 9 g/dL
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
Bilirubin up to 2.5 x ULN
Alkaline phosphatase up to 2.5 x ULN
Creatinine up to 1.5 x ULN
Age 18 years or older at registration
Participants must have at least two intact (undissected) axillary and/or inguinal lymph node basins

Exclusion Criteria

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
Corticosteroids, administered transdermally, parenterally or orally. Inhaled steroids (e.g.: Advair, Flovent, Azmacort) are not permitted. Topical corticosteroids are acceptable
Growth factors (e.g. Procrit, Aranesp, Neulasta)
Interleukins (e.g. Proleukin)
Any investigational medication
HIV positivity or evidence of active Hepatitis C virus
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 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 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
Participants with uncontrolled diabetes, defined as having a HgB-A1c greater than 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
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 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
Body weight < 110 pounds
Participants with a known history of glucose-6-phosphate dehydrogenase deficiency
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