What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly those involving mRNA technology and immune checkpoint inhibitors like pembrolizumab, often have side effects such as fatigue, anemia, decreased neutrophil and white-cell counts, and gastrointestinal issues like diarrhea. Immune-related adverse events can include pneumonitis, rash, and pruritus. These treatments may also lead to more severe conditions like myelodysplastic syndrome or febrile neutropenia in some cases.

What prior FDA approvals exist?

The FDA has approved several mRNA-based therapies for the treatment of solid tumors. One notable example is the approval of mRNA vaccines for cancer immunotherapy, which work by encoding tumor-associated antigens to stimulate an immune response against cancer cells. Additionally, mRNA technology has been explored in combination with immune checkpoint inhibitors like pembrolizumab to enhance anti-tumor activity. These therapies represent a promising approach in the treatment of various solid tumors by leveraging the body's immune system to target and destroy cancer cells.

What other types of research exist?

Promising novel alternatives to mRNA-4359 for solid tumor patients in 2024 include: 1) Antisense oligonucleotide therapies like Tofersen for specific genetic mutations, 2) Adeno-associated virus (AAV) based gene therapies for targeted gene suppression, and 3) Immune checkpoint inhibitors such as pembrolizumab and atezolizumab, which have shown efficacy in various solid tumors.

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mRNA Therapy

mRNA-4359 + Pembrolizumab for Solid Cancers

Phase 1 & 2

Recruiting

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to approximately 27 months after the last dose of study treatment (duration of study treatment is up to nine 21-day cycles), or until disease progression, whichever occurs first

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety of mRNA-4359 alone and with pembrolizumab in likely cancer patients. mRNA-4359 helps cells make a helpful protein, and pembrolizumab boosts the immune system's ability to fight cancer.

Who is the study for?

This trial is for adults with advanced solid tumors, including specific types of lung cancer and melanoma. Participants must have measurable disease, be previously treated or offered targeted therapy (if applicable), and have a performance status indicating they are relatively active. Pregnant women, those with central nervous system metastases, unresolved toxicities from prior treatments, or significant medical conditions that could affect safety or compliance are excluded.

What is being tested?

The study tests mRNA-4359 alone and combined with pembrolizumab to evaluate their safety in treating advanced solid tumors. It involves participants who've had standard treatments but still show progression of the disease. The trial will include biopsies to assess response to these interventions.

What are the potential side effects?

Potential side effects may include typical reactions associated with immunotherapies such as fatigue, flu-like symptoms, allergic reactions at the injection site, and possibly autoimmune responses where the body's immune system attacks normal cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to approximately 27 months after the last dose of study treatment (duration of study treatment is up to nine 21-day cycles), or until disease progression, whichever occurs first

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to approximately 27 months after the last dose of study treatment (duration of study treatment is up to nine 21-day cycles), or until disease progression, whichever occurs first

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to approximately 27 months after the last dose of study treatment (duration of study treatment is up to nine 21-day cycles), or until disease progression, whichever occurs first for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Percent Change from Baseline in T Cell Profile in the Periphery and in the Tumor

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 2 (Dose Expansion): mRNA-4359 in Combination with PembrolizumabExperimental Treatment2 Interventions

Participants will be administered mRNA-4359 in combination with pembrolizumab at an applicable dose.

Group II: Arm 1b (Dose Confirmation): mRNA-4359 in Combination with PembrolizumabExperimental Treatment2 Interventions

Participants will be administered mRNA-4359 in combination with pembrolizumab at an applicable dose.

Group III: Arm 1a (Dose Escalation): mRNA-4359 AloneExperimental Treatment1 Intervention

Participants will be administered mRNA-4359 at an applicable dose as monotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors include chemotherapy, targeted therapy, immunotherapy, and mRNA-based therapies. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects healthy cells, leading to side effects. Targeted therapy aims at specific molecules involved in cancer growth and spread, offering a more precise approach with potentially fewer side effects. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. mRNA-based therapies, like mRNA-4359, use mRNA to instruct cells to produce therapeutic proteins or antigens that can trigger an immune response against cancer cells. This is particularly important for solid tumor patients as it represents a novel and potentially more effective way to target and eliminate cancer cells with reduced systemic toxicity.

[Pancreatic cancer: ten years of systemic therapy].