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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Arm 1: Histologically confirmed advanced or metastatic cancer (cutaneous melanoma, non-small cell lung cancer \[NSCLC\], hepatocellular carcinoma \[HCC\], esophageal carcinoma, head and neck squamous cell carcinoma \[HNSCC\], colon/rectal adenocarcinomas, urothelial/bladder, gastric, ovarian, cervical, and endometrial carcinomas) with measurable disease as determined by Response Evaluation Criteria In Solid Tumors version 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 (cutaneous 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 in the advanced/metastatic disease setting). Participants must have archival or fresh tumor tissue available for submission at Screening.
* 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 highly sensitive 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 it's running

• 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
• START Los Angeles
  Los Angeles, California, United States Not yet recruiting

Study contacts

• Study coordinator: Moderna WeCare Team
• Email: WeCareClinicalTrials@modernatx.com
• Phone: 1-866-663-3762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.