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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

Must not have

Has residual thrombus post nephrectomy in the vena renalis or vena cava

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 42 months (database cutoff date 14 dec 2020)

Awards & highlights

Pivotal Trial

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.

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.

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 below

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My kidney cancer diagnosis includes clear cell characteristics.

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My kidney cancer is at an intermediate to high risk level or I have no signs of disease after metastasis.

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I had kidney surgery to remove cancer, and all the cancer was removed.

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I have not had any treatment for advanced kidney cancer.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have blood clots in my veins after kidney surgery.

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

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I have had pneumonitis treated with steroids or have it now.

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I have been treated with specific immune system targeting drugs or participated in a Merck pembrolizumab trial.

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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.

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I am currently on or have a history of dialysis.

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I have not had major surgery, except for kidney removal or tumor removal, in the last 12 weeks.

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My cancer has spread to my brain or bones.

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I am currently being treated for an infection.

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I have an active tuberculosis infection.

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I have had radiation therapy for kidney cancer.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 42 months (database cutoff date 14 dec 2020) 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) as Assessed by the Investigator

Secondary study objectives

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 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 3

~2810

0 / 16Eligibility criteria met