Pembrolizumab for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+250 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

Stay on Your Current Meds

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.

Eligibility Criteria

Adults who've had kidney cancer surgery with intermediate to high risk of recurrence, or no evidence of disease after metastasis removal. They must have good organ function, agree to contraception for 120 days post-treatment, and not have received prior advanced RCC therapy. Exclusions include recent other cancer treatments, major surgeries (other than nephrectomy/metastasectomy), dialysis history, active infections like HIV/hepatitis B/C, pregnancy/breastfeeding intentions during the study period.

Inclusion Criteria

My organs are functioning well.

I had surgery to remove a kidney or cancer spread at least 28 days ago but no more than 12 weeks ago.

My kidney cancer diagnosis includes clear cell characteristics.

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Exclusion Criteria

I have had cancer before, but it was treated and is not currently active, except for certain skin cancers or early-stage cancers.

I have blood clots in my veins after kidney surgery.

I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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Treatment Details

Interventions

Pembrolizumab (Monoclonal Antibodies)
Placebo (Other)

Trial OverviewThe trial tests pembrolizumab's effectiveness in preventing kidney cancer from returning after surgery compared to a placebo. Participants are randomly assigned to receive either pembrolizumab or a placebo and monitored for disease-free survival as the main outcome.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PembrolizumabExperimental Treatment1 Intervention

Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).

Group II: PlaceboPlacebo Group1 Intervention

Participants receive placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: