A Study of mRNA-4106 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Solid Tumors

NCT06880549 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: mRNA-4106-P101
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the safety and tolerability of mRNA-4106 administered alone and in combination with checkpoint inhibitor (CPI) therapy in participants with solid tumors.

Conditions

Advanced Solid Tumors

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose Limiting Toxicities (DLTs)

  For Arm 1: Days 1-21 and Arm 2: Days 1-28

• Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest

  Up to 2 years

Study Arms (2)

Arm 1 (Dose Escalation): mRNA-4106 Alone

EXPERIMENTAL

Participants will receive mRNA-4106 at a test dose as monotherapy.

Biological: mRNA-4106

Arm 2 (Dose Confirmation): mRNA-4106 in Combination with Nivolumab/Relatlimab

EXPERIMENTAL

Participants will receive mRNA-4106 at an applicable dose in combination with nivolumab/relatlimab at a standard dose.

Biological: mRNA-4106; Biological: Nivolumab/Relatlimab

Interventions

mRNA-4106 BIOLOGICAL

Intramuscular Injection

Arm 1 (Dose Escalation): mRNA-4106 Alone; Arm 2 (Dose Confirmation): mRNA-4106 in Combination with Nivolumab/Relatlimab

Nivolumab/Relatlimab BIOLOGICAL

Intravenous infusion

Arm 2 (Dose Confirmation): mRNA-4106 in Combination with Nivolumab/Relatlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (3)

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

START San Antonio

San Antonio, Texas, 78229, United States

Location

START Mountain Region

West Valley City, Utah, 84119, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Recurrence; Neoplasms; Melanoma

Interventions

Nivolumab; relatlimab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): January 10, 2029
• Study Completion (Estimated): January 10, 2029
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

US (3)