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|
- - Male or female, ≥18 years old with the ability to understand and provide signed and witnessed informed consent, and agree to comply with protocol requirements.
- - Part A: Participants must have one of the histologically-confirmed solid malignancies listed below, must be clinically disease-free at study entry (that is, participants in the adjuvant setting).
- - Part B: Participants must have one of the histologically- or cytologically-confirmed unresectable (locally advanced or metastatic) solid malignancies listed below, have measurable disease at study entry defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
- - Part C: Participants must have one of the histologically- or cytologically confirmed unresectable (locally advanced or metastatic) solid malignancies listed below, must not have received prior anti-programmed cell death protein 1 (PD-1)/programmed death -ligand 1 (PD-L1) therapy, and must have measurable disease at study entry defined by RECIST 1.1.
- - Part D: Participants must have completed resected adjuvant melanoma and must be clinically disease-free at study entry.
- - Parts A and D: Participants must have a formalin-fixed paraffin embedded (FFPE) tumor sample available (for example, from their prior surgery) that is suitable for the next generation sequencing (NGS) required for this study.
- - Parts B and C: Participants must have at least 1 lesion amenable to the mandatory fresh tumor biopsy at study entry and provide a biopsy suitable for the next generation sequencing (NGS) required for this study.
- - Participants must have resolution of toxic effect(s) from prior therapy to Grade 1 or less.
- - Participant is willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug (male and female participants of childbearing potential).
- - Participants with Performance Scale (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) PS.
- - Life expectancy >12 weeks at Screening.
- - Participants with adequate organ and marrow function.
- - Parts A and D: Participant must consent to required apheresis procedure and meet additional inclusion criteria per local institutional apheresis procedure.
- - Treatment with any of the following: 1.
- - Prior PD-1/PD-L1 treatment is permitted for participants in Parts A, B, and D of this study, but only participants who have progressed on their prior PD-1/PD-L1 treatment without a partial or complete response, and without discontinuing for drug-related toxicity are eligible.
- - Active central nervous system metastases and/or carcinomatous meningitis.
- - Active autoimmune disease that has required systemic treatment in past 2 years.
- - Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
- - Has a diagnosis of immunodeficiency.
- - Any clinically-significant cardiac disease defined as New York Heart Association Class III or IV within the past 6 months of Screening, unless, in the opinion of the Investigator, the disease is well-controlled.
- - A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
- - Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- - Previously identified hypersensitivity to components of the formulations used in this study.
- - Had a solid organ or allogeneic bone marrow transplant.
- - Participants with a history of interstitial lung disease.
- - An active infection requiring systemic therapy.
- - A known history of human immunodeficiency virus (HIV) - Known active Hepatitis B or Hepatitis C.
- - Known additional malignancy that is progressing or requires active treatment, exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone curative therapy, or in situ cervical cancer.
- - Participants participating in apheresis; mandatory in the Part A apheresis expansion phase cohort and Part D (optional for other study parts), must not meet any of the exclusion criteria on any day when apheresis is performed, either protocol specific apheresis criteria, or per local institutional apheresis protocol.
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.
The disease, disorder, syndrome, illness, or injury that is being studied.
This is a multi-part, dose-escalation study of mRNA-4157 monotherapy in participants with resected solid tumors (Part A) and of mRNA-4157 in combination with pembrolizumab in participants with both unresectable (locally advanced or metastatic) solid tumors (Parts B and C) and resected cutaneous melanoma (Part D). Parts A and B will include a dose escalation phase of the study to identify doses of mRNA-4157 for the expansion phase of the study. Doses of mRNA-4157 will be administered to participants in a dose escalation regimen. Participants in Parts B, C, and D dose expansion phase will receive mRNA-4157 at a recommended dose for expansion.
Experimental: Part A: Dose Escalation
Participants will receive a fixed applicable dose of mRNA-4157 administered via an intramuscular (IM) injection on Day 1 of each 21-day cycle for up to 9 cycles.
Experimental: Part B: Dose Escalation
Participants will receive a fixed applicable dose of mRNA-4157 administered via an IM injection on Day 1 of each 21-day cycle for up to 9 cycles and fixed-dose of pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 35 cycles (approximately 2 years of treatment), whichever is sooner.
Experimental: Part A: Dose Expansion
Participants will receive mRNA-4157 via IM injection at an applicable dose, identified during the dose escalation phase of the study, on Day 1 of each 21-day cycle for up to 9 cycles.
Experimental: Part B, C, and D: Dose Expansion
Participants will receive mRNA-4157 via IM injection at an applicable dose, identified during the dose escalation phase of the study, on Day 1 of each 21-day cycle for up to 9 cycles. Participants will also receive a fixed-dose of pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 35 cycles (approximately 2 years of treatment), whichever is sooner.
Biological: - mRNA-4157
Personalized cancer vaccine, IM injection
Biological: - Pembrolizumab
Contact a Trial Team
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