Testing mRNA-4106 alone and with immune therapy for advanced solid tumors

A Phase 1, Open-label, Multicenter, Dose-escalation Study of mRNA-4106 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Solid Tumors

This study is testing a new treatment called mRNA-4106, both by itself and with other immune therapies, to see if it can help people with advanced solid tumors who have run out of other options or are newly diagnosed.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ModernaTX, Inc. (Industry-sponsored)
• Drugs / interventions: Nivolumab, Relatlimab, chemotherapy, immunotherapy, prednisone
• Locations: 3 sites (Grand Rapids, Michigan and 2 other locations)
• Trial ID: NCT06880549 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of mRNA-4106, both as a standalone treatment and in combination with immune checkpoint inhibitors, in patients with advanced solid tumors. Participants will be divided into two arms: one receiving mRNA-4106 alone and the other receiving it alongside nivolumab and relatlimab. The study aims to determine the effectiveness of this novel therapy in patients who have exhausted standard treatment options or are newly diagnosed with specific types of advanced cancers. The assessment will include monitoring for adverse effects and measuring tumor response according to established criteria.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed advanced or metastatic solid tumors who have either completed or refused standard therapies.

Not a fit: Patients with resectable tumors or those who have not yet received any prior therapy for their specific cancer type may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies involving mRNA therapies and immune checkpoint inhibitors have shown promising results, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Arm 1, Monotherapy Arm: 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 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, Combination with Nivolumab/Relatlimab Arm: Histologically confirmed unresectable or metastatic melanoma, with measurable disease as determined by RECIST v1.1 and have not had any prior therapy for this cancer in this setting (that is, first-line therapy). Note that prior adjuvant, neoadjuvant, or perioperative melanoma therapy (that is, anti-CTLA-4, anti-PD1/L1, BRAF/MEK inhibitors, or interferon) is permitted if disease recurrence did not occur within 3 months from the last treatment date.
* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
* Participant has adequate hematological and biological function.
* Participants who could become pregnant: negative pregnancy test within 24 hours before the first dose of study treatment.

Exclusion Criteria:

* Participant has active central nervous system tumors or metastases
* Participant has received treatment with prohibited medications/treatments (ie, 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.
* Participant has required the use of immunosuppressive doses of systemic steroids or absorbed topical steroids (doses \>10 mg prednisone daily equivalent) within 2 weeks before study treatment administration or currently requiring maintenance doses of \>10 mg prednisone or equivalent per day.
* 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.
* Participant has reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and prespecified laboratory values.
* 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.
* 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 this trial is running

Grand Rapids, Michigan and 2 other locations

• START Midwest — Grand Rapids, Michigan, United States (Recruiting)
• START San Antonio — San Antonio, Texas, United States (Recruiting)
• START Mountain Region — West Valley City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Moderna WeCare Team

Conditions Advanced Solid Tumors; Locally advanced; Metastatic; Relapsed or refractory solid tumor malignancies; Nivolumab/relatlimab; Oncology; Melanoma; Solid tumors