NCT06880549 · ModernaTX, Inc.
A Study of mRNA-4106 or mRNA-4200 Administered Alone or in Combination With Anti-Cancer Agents in Participants With Solid Tumors
What this study is about
The purpose of this study is to assess the safety and how well patients handle the treatment of mRNA-4106 treatment given alone and of mRNA-4200 in combination with checkpoint inhibitor therapy in participants with solid tumors.
View original scientific description
The purpose of this study is to assess the safety and tolerability of mRNA-4106 monotherapy and of mRNA-4200 in combination with checkpoint inhibitor therapy in participants with solid tumors.
Interventions
BIOLOGICAL
mRNA-4106
Intramuscular injection
BIOLOGICAL
Pembrolizumab
Intravenous infusion
BIOLOGICAL
mRNA-4200
Intramuscular injection
Primary outcome measures
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: For Arm 1: Days 1-21 and Arm 2: Days 1-42
Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Time frame: Up to 2 years and 3 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Los Angeles, California
- Grand Rapids, Michigan
- San Antonio, Texas
- West Valley City, Utah
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2026 · Source of record for eligibility and locations