Recruiting
Phase 1

mRNA-4106 & Immune Checkpoint Blockade

Sponsor:

Moderna

Code:

NCT06880549

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mRNA-4106

Pembrolizumab

mRNA-4200

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumors

Study ID

NCT06880549

Start date

Mar 25, 2025

Status verified date

Aug, 2026

Completion date

Aug 3, 2027

Anticipated

Primary completion date

Aug 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key 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.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 (Dose Escalation): mRNA-4106 Alone

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

experimental: Arm 2 (Dose Escalation): mRNA-4200 Alone and in Combination with Pembrolizumab

Participants will receive mRNA-4200 as monotherapy, followed by mRNA-4200 in combination with pembrolizumab, and continuation of pembrolizumab alone.

Interventions

mRNA-4106

Intramuscular injection

Pembrolizumab

Intravenous infusion

mRNA-4200

Intramuscular injection

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

More Information

Sponsor

ModernaTX, Inc.

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Locally advanced
  • Metastatic
  • Relapsed or refractory solid tumor malignancies
  • Pembrolizumab
  • Oncology
  • Melanoma
  • Solid tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ModernaTX, Inc. on 2026-08-10.