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Cancer Vaccine

mRNA-4157 + Pembrolizumab for Cancer (KEYNOTE-603 Trial)

Phase 1
Recruiting
Research Sponsored by ModernaTX, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with completely resected Stage II, III or IV cutaneous melanoma
Participants must have formalin-fixed paraffin embedded (FFPE) tumor sample available for NGS, and at least 1 lesion amenable to fresh tumor biopsy at study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through disease progression by response evaluation criteria of solid tumors version 1.1 (recist 1.1), start of new anti-cancer therapy, withdrawal of consent, death and last safety follow-up visit (up to approximately 3 years)
Awards & highlights

KEYNOTE-603 Trial Summary

This trial is testing a new cancer treatment that uses a person's own immune system to fight the disease.

Who is the study for?
Adults with certain unresectable solid tumors or those who are disease-free after resection can join. They must have measurable disease, not received prior PD-1/PD-L1 therapy (for some parts), and be suitable for pembrolizumab treatment. Participants need a tumor sample for sequencing and agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the safety and immune response to mRNA-4157 alone in patients with removed tumors, and combined with pembrolizumab in those with unresectable tumors. It aims to understand how well these treatments are tolerated.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, flu-like symptoms such as fever or chills, fatigue, muscle pain, joint pain, headaches, possible autoimmune responses due to pembrolizumab's effect on the immune system.

KEYNOTE-603 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My skin cancer was surgically removed and was stage II, III, or IV.
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I have a tumor sample for testing and at least one tumor that can be biopsied.
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My cancer is advanced, cannot be surgically removed, and can be measured for changes.
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I am currently free from any signs of cancer.
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My cancer is advanced, can't be removed by surgery, and hasn't been treated with anti-PD-1/PD-L1 therapy.
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I had surgery for pancreatic cancer with no signs of spread and am ready for additional treatment.
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I have Stage II-IIIB lung or advanced stomach cancer with tissue samples available.
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I am fully active or restricted in physically strenuous activity but can do light work.

KEYNOTE-603 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through disease progression by response evaluation criteria of solid tumors version 1.1 (recist 1.1), start of new anti-cancer therapy, withdrawal of consent, death and last safety follow-up visit (up to approximately 3 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through disease progression by response evaluation criteria of solid tumors version 1.1 (recist 1.1), start of new anti-cancer therapy, withdrawal of consent, death and last safety follow-up visit (up to approximately 3 years) for reporting.

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
Secondary outcome measures
Part A2: Recurrence-free Survival (RFS)
Part C: Duration of Response (DoR)
Part C: Overall Response Rate (ORR): Number of Participants with Tumor Response (Partial or Complete)
+5 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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

KEYNOTE-603 Trial Design

8Treatment groups
Experimental Treatment
Group I: Part E3: Dose ExpansionExperimental Treatment3 Interventions
Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle, pembrolizumab Q3W via IV infusion, and SoC chemotherapy Q2W or Q3W for up to 4 cycles during the perioperative and adjuvant phases.
Group II: Part E2: Dose ExpansionExperimental Treatment3 Interventions
Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle, pembrolizumab Q6W via IV infusion, and SoC chemotherapy Q3W for up to 4 cycles during the perioperative and adjuvant phases.
Group III: Part E1: Dose ExpansionExperimental Treatment3 Interventions
Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle, pembrolizumab every 6 weeks (Q6W) via IV infusion, and SoC chemotherapy every 3 weeks (Q3W) for up to 4 cycles during the perioperative and adjuvant phases.
Group IV: Part D: Dose ExpansionExperimental Treatment2 Interventions
Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle for up to 9 cycles and pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 18 cycles (approximately 1 year of treatment), whichever is sooner.
Group V: Part C: Dose ExpansionExperimental Treatment2 Interventions
Participants will receive mRNA-4157 via IM injection on Day 1 of each 21-day cycle for up to 9 cycles and pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 35 cycles (approximately 2 years of treatment), whichever is sooner.
Group VI: Part B: Dose Escalation and Dose ExpansionExperimental Treatment2 Interventions
Participants will receive mRNA-4157 via an IM injection on Day 1 of each 21-day cycle for up to 9 cycles and pembrolizumab via IV infusion on Day 1 of each 21-day cycle until progression, unacceptable toxicity, or up to 35 cycles (approximately 2 years of treatment), whichever is sooner.
Group VII: Part A: Dose Escalation and Dose ExpansionExperimental Treatment1 Intervention
Participants will receive mRNA-4157 via an intramuscular (IM) injection on Day 1 of each 21-day cycle for up to 9 cycles.
Group VIII: Part A2: Dose ExpansionExperimental Treatment2 Interventions
Participants will receive mRNA-4157 via an IM injection on Day 1 of each 21-day cycle and a SoC treatment every 2 weeks (Q2W) on Day 1 of each 21-day cycle starting from Cycle 5 of mRNA-4157 for up to 12 cycles.
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
61,379,075 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,891 Previous Clinical Trials
5,060,179 Total Patients Enrolled

Media Library

mRNA-4157 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03313778 — Phase 1
Solid Tumors Research Study Groups: Part E3: Dose Expansion, Part B: Dose Escalation and Dose Expansion, Part A: Dose Escalation and Dose Expansion, Part E1: Dose Expansion, Part E2: Dose Expansion, Part D: Dose Expansion, Part C: Dose Expansion, Part A2: Dose Expansion
Solid Tumors Clinical Trial 2023: mRNA-4157 Highlights & Side Effects. Trial Name: NCT03313778 — Phase 1
mRNA-4157 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03313778 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been any prior experiments with mRNA-4157?

"mRNA-4157 was initially studied by the City of Hope back in 2010 and has since gone on to have 251 trials concluded. Currently, there are 961 open clinical studies with a sizeable portion being conducted out of Cleveland, Ohio."

Answered by AI

How many individuals are being administered treatment through this research project?

"This research project necessitates 143 individuals that meet the pre-defined criteria. Merck Sharp & Dohme LLC will manage this experiment at The Cleveland Clinic Foundation in Ohio and NYU Langone in New york City."

Answered by AI

Are there any vacancies available for participants in this trial?

"This clinical trial is open to new participants, as reported on the clinicaltrials.gov website. Initially posted in August 2017 and amended lastly in September 2022, this study seeks qualified volunteers."

Answered by AI

Has the Food and Drug Administration endorsed mRNA-4157?

"At Power, we have rated the safety of mRNA-4157 a 1 on account of it being in its first phase. This implies that there is limited data surrounding both its efficacy and safety profile."

Answered by AI

What medical conditions can be treated with mRNA-4157?

"mRNA-4157 has been shown to be effective in treating malignant neoplasms, unresectable melanoma, and cases of microsatellite instability high."

Answered by AI

How extensively is this clinical investigation being studied in North America?

"This clinical trial is operating from The Cleveland Clinic Foundation in Ohio, NYU Langone in NYC, and H Lee Moffitt Cancer Center & Research Institute in Florida. In addition to these locations, it runs at 9 other sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors
2017. "Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03313778.
~36 spots leftby Jun 2025
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