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V940 + Pembrolizumab for Kidney Cancer

Phase 2

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~96 months

Awards & highlights

Study Summary

This trial aims to see if adding V940 to pembrolizumab is better than adding a placebo to pembrolizumab in terms of how long patients remain free of disease. The main

Who is the study for?

This trial is for adults with a specific kidney cancer (clear cell or papillary renal cell carcinoma). They should be at intermediate-high risk, have had surgery to remove the tumor and any isolated metastases within the last 12 weeks, and be in good physical condition (ECOG status of 0 or 1).Check my eligibility

What is being tested?

The study aims to see if adding V940 to pembrolizumab improves disease-free survival compared to using pembrolizumab with a placebo. Participants will randomly receive either the combination of V940 and pembrolizumab or a placebo plus pembrolizumab.See study design

What are the potential side effects?

Possible side effects include immune system reactions that can affect organs, infusion-related symptoms, fatigue, nausea, skin rash, and an increased chance of infections. The severity of side effects may vary among individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~96 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~96 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~96 months 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

Distant Metastasis-free survival (DMFS)

Overall Survival (OS)

Percentage of Participants Who Discontinue Study Treatment Due to an AE

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: V940 + PembrolizumabExperimental Treatment2 Interventions

Participants will receive V940 1 mg via intramuscular (IM) injection every 3 weeks (Q3W) for up to 9 doses plus Pembrolizumab 400 mg via an intravenous (IV) infusion every 6 weeks (Q6W) for 9 cycles (up to ~54 weeks). Each cycle is 6 weeks.

Group II: Placebo + PembrolizumabActive Control2 Interventions

Participants will receive placebo as an IM injection Q3W for up to 9 doses plus Pembrolizumab 400 mg via an IV infusion Q6W for 9 cycles (up to ~54 weeks). Each cycle is 6 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,896 Previous Clinical Trials

5,062,446 Total Patients Enrolled

ModernaTX, Inc.Industry Sponsor

108 Previous Clinical Trials

61,379,641 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,782 Previous Clinical Trials

8,066,044 Total Patients Enrolled

Frequently Asked Questions

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

What is the overall count of individuals participating in this clinical study?

"Indeed, the details on clinicaltrials.gov reveal that this current medical trial is actively seeking potential participants. Originally shared on April 22nd, 2024, and most recently revised on April 8th, 2024, the study aims to enlist a total of 272 individuals from two distinct locations."

Answered by AI

What are the potential risks associated with administering V940 in combination with Pembrolizumab to individuals?

"The safety evaluation of V940 + Pembrolizumab by our team at Power is rated as 2 on a scale from 1 to 3. This assessment is based on available safety data in this Phase 2 trial, with no substantial evidence yet supporting efficacy."

Answered by AI

Is the enrollment of participants currently ongoing for this research study?

"As per clinicaltrials.gov, this clinical investigation is actively seeking volunteers. The trial was initially listed on April 22nd, 2024 and last revised on April 8th of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)

2024. "A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06307431.

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