Your session is about to expire
← Back to Search
Monoclonal Antibodies
Pembrolizumab for Kidney Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has histologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell component with or without sarcomatoid features
Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by specific pathological tumor-node-metastasis and Fuhrman grading status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 42 months (database cutoff date 14 dec 2020)
Awards & highlights
Study Summary
This trial is testing whether the drug pembrolizumab can help prevent renal cell cancer from coming back after surgery.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroid disorders), and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer diagnosis includes clear cell characteristics.
Select...
My kidney cancer is at an intermediate to high risk level or I have no signs of disease after metastasis.
Select...
I had kidney surgery to remove cancer, and all the cancer was removed.
Select...
I have not had any treatment for advanced kidney cancer.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 42 months (database cutoff date 14 dec 2020)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 42 months (database cutoff date 14 dec 2020)
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) as Assessed by the Investigator
Secondary outcome measures
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score
Change From Baseline in the Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score
DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator
+7 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,828 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,577 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,486 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I have had cancer before, but it was treated and is not currently active, except for certain skin cancers or early-stage cancers.I had surgery to remove a kidney or cancer spread at least 28 days ago but no more than 12 weeks ago.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.My kidney cancer diagnosis includes clear cell characteristics.I have had pneumonitis treated with steroids or have it now.I have no tumors, confirmed by scans within the last 28 days.I agree to use birth control during and up to 120 days after the study.I am a man who can father children and agree to use birth control during and for 4 months after treatment.My kidney cancer is at an intermediate to high risk level or I have no signs of disease after metastasis.I had kidney surgery to remove cancer, and all the cancer was removed.I have been treated with specific immune system targeting drugs or participated in a Merck pembrolizumab trial.I haven't had cancer treatment or been in a trial for at least 4 weeks or 5 half-lives, and I've recovered from any side effects.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.You currently have an active hepatitis B or C virus infection.You have had an organ transplant in the past.I am currently on or have a history of dialysis.I have not had any treatment for advanced kidney cancer.I have not had major surgery, except for kidney removal or tumor removal, in the last 12 weeks.You have been diagnosed with HIV.I have provided the required tissue samples from my kidney surgery and any cancer removal surgeries.My cancer has spread to my brain or bones.I have not received a live vaccine in the last 30 days.I am currently being treated for an infection.I have an active tuberculosis infection.I have had radiation therapy for kidney cancer.I have an autoimmune disease treated with strong medication in the last 2 years.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial common in large metropolitan areas?
"This study is currently enrolling patients at 75 sites across America, including locations in Phoenix, Spokane and Los Angeles. To help reduce the demand on participants, it is encouraged that you pick a location closest to your home."
Answered by AI
What are the chief benefits of Pembrolizumab?
"Pembrolizumab is an immunotherapy medication used to treat various cancers, such as malignant neoplasms, unresectable melanoma, and microsatellite instability high."
Answered by AI
How many people are currently being enrolled in this trial?
"Unfortunately, this study is not currently enrolling patients. It was originally posted on June 9th, 2017 and last updated on November 29th, 2021. However, there are 2665 other trials for carcinoma and 1000 for Pembrolizumab that are recruiting right now."
Answered by AI
What other medical investigations have included Pembrolizumab?
"There are currently 1000 ongoing clinical trials investigating pembrolizumab. Out of those, 122 have reached phase 3. The majority of these studies take place in Houston, Texas; however, there are 36021 locations worldwide where research is being conducted."
Answered by AI
Are there long-term risks to taking Pembrolizumab?
"Pembrolizumab has received a score of 3 for safety. This is due to it being a Phase 3 trial, which means that there is both efficacy data and multiple rounds of safety data available."
Answered by AI
Are there still any places open in this trial for new participants?
"Unfortunately, this specific study is not presently enrolling patients. This clinical trial was first posted on June 9th, 2017 and had its last update on November 29th, 2021. With that said, there are 3665 other trials which are still recruiting."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger