Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors
NCT ID: NCT03313778
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
242 participants
INTERVENTIONAL
2017-08-14
2027-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: Dose Escalation and Dose Expansion
Participants will receive mRNA-4157 via an intramuscular (IM) injection on Day 1 of each 21-day cycle for up to 9 cycles.
mRNA-4157
IM injection
Part B: Dose Escalation and Dose Expansion
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.
mRNA-4157
IM injection
Pembrolizumab
Intravenous infusion
Part A2: Dose Expansion
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.
mRNA-4157
IM injection
SoC Treatment
Intravenous infusion
Part C: Dose Expansion
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.
mRNA-4157
IM injection
Pembrolizumab
Intravenous infusion
Part D: Dose Expansion
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.
mRNA-4157
IM injection
Pembrolizumab
Intravenous infusion
Part E1: Dose Expansion
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.
mRNA-4157
IM injection
Pembrolizumab
Intravenous infusion
SoC Treatment
Intravenous infusion
Part E2: Dose Expansion
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.
mRNA-4157
IM injection
Pembrolizumab
Intravenous infusion
SoC Treatment
Intravenous infusion
Part E3: Dose Expansion
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.
mRNA-4157
IM injection
Pembrolizumab
Intravenous infusion
SoC Treatment
Intravenous infusion
Interventions
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mRNA-4157
IM injection
Pembrolizumab
Intravenous infusion
SoC Treatment
Intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Part B: Participants must have one of the histologically- or cytologically-confirmed unresectable (locally advanced or metastatic) protocol-specified solid malignancies, have measurable disease at study entry defined by RECIST 1.1., and be considered suitable for treatment with pembrolizumab; in this study pembrolizumab will be considered an investigational study drug.
* Part C: Participants must have one of the histologically- or cytologically confirmed unresectable (locally advanced or metastatic) protocol-specified solid malignancies, must not have received prior anti-programmed cell death protein 1 (PD-1)/programmed death -ligand 1 (PD-L1) therapy, and must have measurable disease at study entry defined by RECIST 1.1.
* Part A2: Participants with histologically confirmed PDAC who have undergone complete macroscopic resection(that is, R0 - no cancer cells within 1 mm of all resection margins or R1 - cancer cells present within 1 mm of one or more resection margins) who had no evidence of metastatic disease with adequate recovery from surgery to receive adjuvant therapy.
* Parts E1 and E2: Participants with untreated histologically/cytologically confirmed Stage II-IIIB NSCLC (per AJCC version 8) that is considered resectable of non-squamous (adenocarcinoma only) or squamous cell carcinoma histology, absence of major associated pathologies that increase the surgery risk to an unacceptable level, must have a tumor tissue sample available for NGS and PD-L1 IHC testing as defined in the Laboratory Manual.
* Part E3: Participants with untreated, locally advanced surgically resectable, histologically/cytologically confirmed, gastric/GEJ adenocarcinoma, as defined by a primary lesion that is T3 or greater or with the presence of any positive clinical nodes (N+) and without evidence of metastatic disease, measurable disease according to RECIST version 1.1, absence of major associated pathologies that increase the surgery risk to an unacceptable level, must have a tumor tissue sample available for NGS and PD-L1 IHC testing as defined in the Laboratory Manual.
* Part D: Participants with completely resected Stage II, III or IV cutaneous melanoma.
* Parts A, A2, and D: Participants must have a formalin-fixed paraffin embedded (FFPE) tumor sample available (for example, from their prior surgery) that is suitable for the next generation sequencing (NGS) required for this study.
* Parts B and C: Participants must have at least 1 lesion amenable to the mandatory fresh tumor biopsy at study entry.
* Participants must have resolution of toxic effect(s) (as specified in the protocol) from prior therapy to Grade 1 or less.
* Participant is willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug (male and female participants of childbearing potential), or for a specified time after the last dose of SoC chemotherapy per SoC product labeling, whichever is later.
* Participants with Performance Scale (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) PS.
Exclusion Criteria
1. Any investigational agents, anti-cancer monoclonal antibody, anti-cancer therapeutic vaccine, immunostimulant (for example, IL-2), or study drugs from a previous clinical study within 4 weeks of the first dose of mRNA-4157 or pembrolizumab (note only a 2 week wash out is required from prior pembrolizumab treatment)
2. Any chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of the first dose of mRNA-4157 or pembrolizumab
3. Live-virus vaccination within 30 days of the first dose of mRNA-4157 or pembrolizumab. Seasonal flu vaccines that do not contain live virus are permitted.
4. Any systemic steroid therapy or other form of immunosuppressive therapy within 7 days of the first dose of mRNA-4157 or pembrolizumab
5. Transfusion of blood products (including platelets or red blood cells \[RBCs\]) or administration of colony stimulating factors (including granulocyte colony stimulating factor \[G-CSF\], granulocyte/macrophage colony stimulating factor \[GM-CSF\], or recombinant erythropoietin) within 1 week of the NGS blood sample during screening, and 4 weeks of the first dose of mRNA-4157 or pembrolizumab
* A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator
* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Previously identified hypersensitivity to chemotherapy agents that the participant would receive in their specific cohort or to components of the formulations used in this study
* Known additional malignancy that is progressing or requires active treatment, exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone curative therapy, or in situ cervical cancer.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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The George Washington Cancer Center
Washington D.C., District of Columbia, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
NYU Langone Medical Center
New York, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Westmead Hospital-Cnr Hawkesbury and Darcy Road
Westmead, New South Wales, Australia
One Clinical Research Perth
Perth, Western Australia, Australia
National Cancer Center East
Chiba, , Japan
Kindai University Hospital
Osaka, , Japan
National Cancer Center Hospital
Tokyo, , Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research
Tokyo, , Japan
NHS Tayside
Dundee, Scotland, United Kingdom
Royal Mardsen London
London, , United Kingdom
Royal Mardsen Sutton
Sutton, , United Kingdom
Countries
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References
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Berraondo P, Cuesta R, Sanmamed MF, Melero I. Immunogenicity and Efficacy of Personalized Adjuvant mRNA Cancer Vaccines. Cancer Discov. 2024 Nov 1;14(11):2021-2024. doi: 10.1158/2159-8290.CD-24-1196.
Other Identifiers
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2023-505192-77-00
Identifier Type: OTHER
Identifier Source: secondary_id
mRNA-4157-P101
Identifier Type: -
Identifier Source: org_study_id
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