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V940 + Pembrolizumab for Kidney Cancer (INTerpath-004 Trial)

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

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).

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease-Free Survival (DFS)

Secondary study objectives

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 3

~3150

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