Can a Ready-Made mRNA vaccine train the immune system to fight many cancers?
NCT ID NCT06880549
First seen Jun 24, 2026 · Last updated Aug 23, 2026 · Updated 4 times
Summary
This Phase 1 trial tests two experimental mRNA immunotherapies, mRNA-4106 and mRNA-4200, in about 42 people with advanced solid tumors. Unlike personalized cancer vaccines made from a patient's own tumor mutations, these are off-the-shelf therapies designed to target shared antigens found across many tumor types. The study aims to assess safety and find the right dose, with mRNA-4106 given alone and mRNA-4200 combined with the checkpoint inhibitor pembrolizumab. The goal is to see whether these therapies can stimulate T-cell responses against common tumor targets, but it is too early to know if they will shrink tumors or extend survival in humans.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mRNA-4106 and mRNA-4200, experimental off-the-shelf mRNA cancer immunotherapies, given alone or with pembrolizumab
- What this could lead to
- If these therapies work, they could offer a ready-made, scalable form of cancer immunotherapy that trains the immune system to attack multiple shared tumor targets across many patients and cancer types.
- What could go wrong
- This is a small Phase 1 trial focused on safety and dosing, with no human efficacy data yet. Shared non-mutated antigens may be weaker immune targets than personalized neoantigens, and previous shared-antigen vaccines have often produced immune responses without strong tumor shrinkage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Arm 1: Histologically confirmed advanced or metastatic cancer (melanoma, non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal carcinoma, head and neck squamous cell carcinoma (HNSCC), urinary bladder cancer (UBC), colon/rectal adenocarcinomas, gastric, ovarian, cervical, and endometrial carcinomas) with measurable disease as determined by Response Evaluation Criteria In Solid Tumors volume 1.1 (RECIST v1.1) and have completed or refused all standard therapies (no limit to prior lines of therapy). Participants must have a tumor lesion amenable to biopsy, or alternatively archival tumor tissue is acceptable as long as the collection date is within one year of the enrollment date. * Arm 2: Histologically confirmed advanced or metastatic cancer (melanoma, NSCLC, esophageal carcinoma, HNSCC, urothelial/bladder carcinoma, gastric, colon/rectal adenocarcinomas, ovarian, cervical, and endometrial carcinomas \[Note: HCC not included\]) with measurable disease as determined by RECIST v1.1 and have completed or refused all standard therapies (no more than 5 prior lines of therapy). Participants must have a tumor lesion amenable to biopsy, or alternatively archival tumor tissue is acceptable if no intervening systemic therapy was received. * Arm 2: Participant life expectancy of ≥90 days. * Arm 1 and Arm 2: Participant has an Eastern Cooperative Oncology Group performance status of ≤1. * Arm 1 and Arm 2: Participant has adequate hematological and biological function. * Arm 1 and Arm 2: Participants who could become pregnant: negative pregnancy test within 24 hours before the first dose of study treatment. Key Exclusion Criteria: * Arm 1 and Arm 2: Participant has active central nervous system tumors or metastases * Arm 1 and Arm 2: Participant has received treatment with prohibited medications/treatments (that is, concurrent anticancer therapy including other chemotherapy, hormonal anticancer therapy, biologic therapy, or immunotherapy) or investigational agents within 5 half-lives or 14 days prior to the first day of study treatment (Cycle 1 Day 1), whichever is shorter. * Arm 1 and Arm 2: Participant has required the use of immunosuppressive doses of systemic steroids or absorbed topical steroids (doses \>10 milligrams \[mg\] prednisone daily equivalent) within 2 weeks before study treatment administration or currently requiring maintenance doses of \>10 mg prednisone or equivalent per day. * Arm 1 and Arm 2: Participant has any plan to receive a live attenuated vaccine during study treatment or has received a live vaccine within 30 days before the first dose of study treatment. * Arm 1 and Arm 2: Participant has reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline. Any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Events Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and prespecified laboratory values. * Arm 1 and Arm 2: Participant has any unstable or clinically significant concurrent medical/psychiatric illness or social situation that would limit compliance with study requirements or compromise the ability of the participant to provide written informed consent, per the discretion of the Investigator. * Arm 1 and Arm 2: Participant has concurrent enrollment in another clinical study (unless it is an observational noninterventional clinical study). Note: Other inclusion and exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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START Los Angeles
NOT_YET_RECRUITINGLos Angeles, California, 90025, United States
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START Midwest
RECRUITINGGrand Rapids, Michigan, 49546, United States
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START Mountain Region
RECRUITINGWest Valley City, Utah, 84119, United States
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START San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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Other studies related to the condition(s) this trial covers.
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