mRNA-5671 / Moderna - LARVOL DELTA

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) (clinicaltrials.gov) - P1 | N=70 | Terminated | Sponsor: Merck Sharp & Dohme LLC | Completed ➔ Terminated; Business Reasons

Monotherapy • Trial termination • Colorectal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ALK • EGFR • KRAS • MSI

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) (clinicaltrials.gov) - P1 | N=70 | Completed | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Completed | N=100 ➔ 70

Combination therapy • Enrollment change • Monotherapy • Trial completion • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ALK • EGFR • KRAS • MSI

The paradigm shift in treatment from Covid-19 to oncology with mRNA vaccines. (PubMed, Cancer Treat Rev) - "The rapid development and large-scale production of mRNA platform has enabled for the development of both personalized vaccines (mRNA 4157, mRNA 4650 and RO7198457) and tetravalent vaccines (BNT111 and mRNA-5671). In other words, while developing a vaccine design, the underlying motivation should be a reasonable combination of delivery route and format. Exploring various administration routes and delivery route systems has boosted the development of mRNA vaccines."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Merck cuts ties to Moderna's early-phase KRAS vaccine, leaving mRNA specialist to mull next steps (FierceBiotech) - "Merck has dumped Moderna’s mutant KRAS vaccine mRNA-5671. The action, which comes shortly after Merck closed enrollment in a phase 1 trial, leaves Moderna pondering the next steps for the program."

Enrollment closed • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) (clinicaltrials.gov) - P1 | N=100 | Active, not recruiting | Sponsor: Merck Sharp & Dohme Corp. | Recruiting ➔ Active, not recruiting | Trial completion date: May 2025 ➔ Aug 2022 | Trial primary completion date: May 2025 ➔ Aug 2022

Combination therapy • Enrollment closed • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ALK • EGFR • KRAS • MSI

[VIRTUAL] Emerging Mechanisms to Target KRAS Directly (IASLC-WCLC 2020) - P1, P1/2 | "In preclinical studies, CD8 T cell responses to KRAS antigens were greatly enhanced following vaccination with mRNA encoding KRAS mutations.[1] A phase I study utilizing V941 with or without pembrolizumab in patients with KRAS mutant advanced or metastatic NSCLC, colorectal cancer (CRC) or pancreatic adenocarcinoma is currently recruiting (NCT03948763, Table1)...The degrader library design was based on using a parental compound chemically related to the mutant-selective covalent inhibitor ARS-1620 as the KRASG12C warhead and thalidomide as the cereblon (CRBN) warhead...Table 1. Vaccine and T cell trials focused on KRAS"

IO biomarker • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • Targeted Protein Degradation • CD8 • CRBN • KRAS

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Trial completion date: Nov 2026 ➔ May 2025; Trial primary completion date: Nov 2026 ➔ May 2025

Clinical • Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • ALK • EGFR • KRAS • MSI

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Trial completion date: May 2024 ➔ Oct 2026; Trial primary completion date: May 2024 ➔ Oct 2026

Clinical • Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Thoracic Cancer

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Trial completion date: Mar 2022 ➔ May 2024; Trial primary completion date: Jun 2021 ➔ May 2024

Clinical • Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • ALK • EGFR • KRAS • MSI-H

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) (clinicaltrials.gov) - P1; N=100; Not yet recruiting; Sponsor: Merck Sharp & Dohme Corp.

Clinical • Combination therapy • IO Biomarker • Monotherapy • New P1 trial • PD(L)-1 Biomarker

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001) (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • IO Biomarker • Monotherapy • PD(L)-1 Biomarker

Moderna provides business updates and reports second quarter 2019 financial results (BioSpace) - "First patient consented in Phase 2 PCV (mRNA-4157) study in patients with resected melanoma; First patient dosed in Phase 1 KRAS cancer vaccine (mRNA-5671 or Merck V941) study; First patient dosed in Phase 1 study of mRNA encoding IL12 (MEDI1191) injected intratumorally."

Enrollment open • Enrollment status