RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-25

Study Completion:2029-01-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06880549

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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).

Inclusion Criteria

Exclusion 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.

* 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).

Contacts and Locations

Study Contact

Moderna WeCare Team

CONTACT

1-866-663-3762

WeCareClinicalTrials@modernatx.com

Study Locations (Sites)

START Midwest

Grand Rapids, Michigan, 49546

United States

START San Antonio

San Antonio, Texas, 78229

United States

START Mountain Region

West Valley City, Utah, 84119

United States

Collaborators and Investigators

Sponsor: ModernaTX, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-25

Study Completion Date2029-01-10

Study Record Updates

Study Start Date2025-03-25

Study Completion Date2029-01-10

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Advanced Solid Tumors