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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

No Placebo-Only Group

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

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)

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

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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 3

~3130

0 / 8Eligibility criteria met