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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06880549
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ModernaTX, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Solid Tumors
Arms & Interventions

Arms

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

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

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

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

Interventions

Biological: - mRNA-4106

Intramuscular Injection

Biological: - Nivolumab/Relatlimab

Intravenous infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

START Midwest, Grand Rapids 4994358, Michigan 5001836

Status

Recruiting

Address

START Midwest

Grand Rapids 4994358, Michigan 5001836, 49546

Site Contact

[email protected]

1-866-663-3762

START San Antonio, San Antonio 4726206, Texas 4736286

Status

Recruiting

Address

START San Antonio

San Antonio 4726206, Texas 4736286, 78229

Site Contact

[email protected]

1-866-663-3762

START Mountain Region, West Valley City 5784607, Utah 5549030

Status

Recruiting

Address

START Mountain Region

West Valley City 5784607, Utah 5549030, 84119

Site Contact

[email protected]

1-866-663-3762

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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