A Clinical Trial to Evaluate a Melanoma Helper Peptide Vaccine Plus Dabrafenib and Trametinib
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, a lymph node, and tumor samples.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
|Eligible Ages||18 Years and Over|
- - Participants with measurable stage IIIB, IIIC, or IV melanoma that have clinical or radiological evidence of disease.
- - Participants must be eligible to be treated with BRAF inhibitor and MEK inhibitor combination.
- - Participants will be required to have radiological studies to define radiologically evident disease.
- - Chest CT scan, - Abdominal and pelvic CT scan, and - Head CT scan or MRI - Participants who have metastatic melanoma available for biopsy pretreatment and on day 22 must consent to having those biopsies.
- - Participants who have had brain metastases will be eligible if all of the following are true: - The total number of brain metastases ever ≤ 3 - 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 ≤ 6 months prior to registration.
- - ECOG performance status of 0 or 1 - 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 ≤ 7.5% - AST and ALT up to 2.5 x upper limits of normal (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.
- - Growth factors (e.g. Procrit®, Aranesp®, Neulasta®) - Interleukins (e.g. Proleukin®) - Any investigational medication - Targeted therapies specific for mutated BRAF - MEK inhibitor - 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.
- - 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 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Craig L Slingluff, Jr|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908