Accepts Healthy Volunteers
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.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence.
- - Complete resection within 13 weeks prior to the first dose of pembrolizumab.
- - Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases.
- - Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing.
- - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- - Normal organ and marrow function reported at screening.
- - Prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry.
- - Prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas.
- - Live vaccine within 30 days prior to the first dose of pembrolizumab.
- - Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample.
- - Active autoimmune disease.
- - Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab.
- - Solid organ or allogeneic bone marrow transplant.
- - Pneumonitis or a history of (noninfectious) pneumonitis that required steroids.
- - Prior interstitial lung disease.
- - Clinically significant heart failure.
- - Known history of human immunodeficiency virus (HIV) - Known active hepatitis B or C.
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 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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Australia, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: mRNA-4157 and Pembrolizumab
Participants will receive up to 9 doses of mRNA-4157 (every 21 days). Participants may continue on pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
Active Comparator: Pembrolizumab
Participants will receive pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.
Biological: - mRNA-4157
Personalized cancer vaccine
Biological: - Pembrolizumab
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you. Please note all sites listed may not currently be active in the trial. Please continue to check back for additional site locations.