Your session is about to expire
← Back to Search
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 up to 34 months
Awards & highlights
Study Summary
This trial is testing a new drug, mRNA-4359, to see if it is safe and if it has any side effects when used alone or with another drug, pembrolizumab.
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.Check my eligibility
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.See study design
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 ~ up to 34 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 34 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Adverse Events (AEs), AE of Special Interest (AESIs), and Serious AEs (SAEs)
Number of Participants with Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Disease Control Rate (DCR) Based on RECIST v1.1
Duration of Response (DOR) Based on RECIST v1.1
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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 2
~2010
Find a Location
Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,379,123 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use condoms or not donate sperm during and up to 120 days after treatment.My side effects from previous cancer treatments are mild or back to normal, except for hair loss or skin changes.I have active brain tumors or cancer that has spread to my brain.I plan to get, or have received a live vaccine recently.I haven't taken any prohibited cancer treatments or investigational drugs recently.I have advanced cancer and my previous treatments didn't work or weren't suitable for me.I need more than 10mg of prednisone daily for an adverse event, besides other immunosuppressants.I have melanoma or NSCLC that didn't respond to checkpoint inhibitors, with a tumor that can be biopsied.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1a (Dose Escalation): mRNA-4359 Alone
- Group 2: Arm 2 (Dose Expansion): mRNA-4359 in Combination with Pembrolizumab
- Group 3: Arm 1b (Dose Confirmation): mRNA-4359 in Combination with Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been accepted into this research study?
"This trial requires 194 suitable individuals to take part. The University of Colorado Cancer Center in Aurora and UCSF Helen Diller Family Comprehensive Cancer Centre are among the multiple locations where patients can apply to enrolment."
Answered by AI
How many medical centers in North America are trialing this research?
"This trial is enrolling patients from 10 sites situated in various cities, including Aurora, San Francisco and Huntersville. Participants are encouraged to select the closest medical centre to minimize travel burdens if they choose to participate."
Answered by AI
Are there any remaining opportunities to join this experimentation?
"Affirmative. Per the information on clinicaltrials.gov, this medical examination is actively recruiting patients. It was first posted in August 18th 2022 and modified for the last time October 24th 2022 with a total of 194 participants needed from 10 different sites."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger