← Back to Search

V940 + Pembrolizumab for Lung Cancer

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab

Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~12 years

Awards & highlights

Study Summary

This trial evaluates V940 + pembrolizumab vs. placebo + pembrolizumab for treating non-small cell lung cancer post-surgery. The primary hypothesis is that V940 + pembrolizumab is better at keeping the cancer away.

Who is the study for?

This trial is for adults with Stage II, IIIA, or IIIB non-small cell lung cancer that's been surgically removed. They must have completed at least one round of standard chemo and can't have any remaining signs of cancer. People with well-controlled HIV on ART, or past hepatitis B/C with undetectable viral loads can join. Exclusions include recent investigational drug use, chronic high-dose steroids, autoimmune disease treatments within 2 years, prior PD-1/PD-L1 therapy, active infections needing systemic treatment.Check my eligibility

What is being tested?

The study tests if adding V940 to pembrolizumab (a known immunotherapy) improves disease-free survival compared to a placebo plus pembrolizumab in patients who've had surgery for NSCLC. Participants are randomly assigned to either the V940 combo or the placebo combo after their surgery and initial chemotherapy.See study design

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects like inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid disorders), and infusion reactions during administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

It's been less than 6 months since my surgery aimed at curing my cancer and starting pembrolizumab.

Select...

I have received at least one round of standard chemotherapy for my cancer.

Select...

I currently show no signs of my disease.

Select...

My lung cancer was surgically removed and confirmed to be Stage II or III.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~12 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~12 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~12 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

Disease- Free Survival (DFS)

Secondary outcome measures

Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30

Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30

Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: V940 + PembrolizumabExperimental Treatment2 Interventions

Participants will receive 1 mg of V940 via intramuscular (IM) injection once every 3 weeks for up to 9 doses PLUS 400 mg of pembrolizumab via intravenous (IV) infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.

Group II: Placebo + PembrolizumabActive Control2 Interventions

Participants will receive V940-matched placebo via IM injection once every 3 weeks for up to 9 doses PLUS 400 mg of pembrolizumab via IV infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Industry Sponsor

108 Previous Clinical Trials

61,378,449 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,278 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,536 Total Patients Enrolled

Frequently Asked Questions

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

Are there still vacancies for volunteers in this investigation?

"According to clinicaltrials.gov, this trial is making an effort to find participants as it has just been updated on November 7th 2021 after initially being posted in late November of that same year."

Answered by AI

What levels of safety have been reported when administering V940 combined with Pembrolizumab?

"Our team at Power rated V940 + Pembrolizumab as a 3 on the safety scale, as there is pre-existing clinical evidence of its efficacy and multiple rounds of data indicating it's overall security."

Answered by AI

What is the size of this medical research project's experimental population?

"Affirmative. According to clinicaltrials.gov, this medical study - which was first created on November 23rd 2023 - is still recruiting participants. The research team aims to obtain 868 patients from 2 sites for the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

2023. "A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077760.

All > Fargo