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A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)

NCT03948763 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-01-28

Study results available
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Summary

This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of V941(mRNA-5671/V941) as a monotherapy and in combination with pembrolizumab infusion.

Conditions

  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Pancreatic Neoplasms
  • Colorectal Neoplasms

Interventions

BIOLOGICAL

V941

V941 administered IM, Q3W for 9 3-week cycles

BIOLOGICAL

Pembrolizumab

Pembrolizumab 200 mg, IV for 35 3-week cycles

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp and Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-26
Primary Completion
2022-08-25
Completion
2022-08-25
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Hong Kong
  • New Zealand
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03948763 on ClinicalTrials.gov