← Back to Search
Tyrosine Kinase Inhibitor
Pembrolizumab +/− Axitinib for Renal Cell Carcinoma
San Francisco, CA
Phase 2
Recruiting
Led By David Y Oh, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed RCC with a clear cell component
At least 18 years of age on day of signing informed consent
Must not have
Female of childbearing potential who has a positive urine pregnancy test within 72 hours prior to allocation
Has had an allogenic tissue/solid organ transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how well pembrolizumab with or without standard of care axitinib works in treating patients with clear cell kidney cancer that has spread.
See full description
Who is the study for?
Adults with advanced or metastatic clear cell kidney cancer who are undergoing surgery may join this trial. They should be in good physical condition, have a tumor that can be biopsied, and agree to use contraception if of childbearing potential. Exclusions include recent anti-cancer treatments, active infections, serious wounds, psychiatric issues affecting participation, pregnancy/breastfeeding intentions within 120 days post-treatment, prior PD-1/PD-L1 therapy or certain autoimmune diseases.Check my eligibility
What is being tested?
The study is testing the effectiveness of pembrolizumab (an immune system booster) alone or combined with axitinib (a drug blocking enzymes promoting cancer growth) compared to standard care involving surgery followed by chemotherapy/radiation. The goal is to see if these drugs better control kidney cancer and reduce its return after surgery.See study design
What are the potential side effects?
Pembrolizumab might cause immune-related reactions like inflammation in organs or skin rashes; axitinib could lead to high blood pressure or liver function changes. Both drugs may increase risks for infection and fatigue among other side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney cancer has been confirmed to have clear cells.
show original
Select...
I am 18 years old or older.
show original
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
show original
Select...
My cancer has spread beyond its original location.
show original
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am a woman who can have children and I had a positive pregnancy test recently.
show original
Select...
I have received an organ or tissue transplant from another person.
show original
Select...
I have or had lung inflammation treated with steroids.
show original
Select...
I am currently on medication for an infection.
show original
Select...
I have been diagnosed with HIV.
show original
Select...
I have an active TB infection.
show original
Select...
I have had a solid organ or bone marrow transplant.
show original
Select...
My high blood pressure is not well-managed despite taking medication.
show original
Select...
I am not eligible for surgery or targeted therapy for my condition.
show original
Select...
I have not experienced brain function issues in the last 6 months.
show original
Select...
I have previously received treatments targeting immune checkpoints.
show original
Select...
I have received systemic therapy for kidney cancer.
show original
Select...
My kidney cancer does not have clear cells.
show original
Select...
I have noticeable swelling in my abdomen.
show original
Select...
I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
show original
Select...
My cancer has spread to the bones but can't be measured by standard tests.
show original
Select...
I have active brain metastases or carcinomatous meningitis.
show original
Select...
I have a history of hepatitis B or an active hepatitis C infection.
show original
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants with >= 2-fold increase in the number of tumor-infiltrating immune cells (TIICs)
Secondary study objectives
Disease-Free Survival Rate (DFS) for participants who obtain CR or PR/SD with R0 resection and are treated 1 year of pembrolizumab-based therapy
Incidence of treatment-related adverse events
Median DFS for participants who obtain CR or PR/SD with R0 resection and are treated 1 year of pembrolizumab-based therapy
+3 moreSide effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Weight decreased
45%
Constipation
44%
Dysphagia
42%
Neutrophil count decreased
33%
Vomiting
33%
Dysgeusia
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypokalaemia
25%
Hypothyroidism
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Blood creatinine increased
23%
Oropharyngeal pain
22%
Diarrhoea
22%
Odynophagia
20%
Alanine aminotransferase increased
20%
Hyponatraemia
20%
Hypoacusis
19%
Asthenia
19%
Oral candidiasis
19%
Tinnitus
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Gamma-glutamyltransferase increased
12%
Dysphonia
11%
Dehydration
11%
Pneumonia
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
10%
Hyperthyroidism
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Hypophosphataemia
8%
Dizziness
8%
Hiccups
8%
Gastrooesophageal reflux disease
7%
Localised oedema
7%
Urinary tract infection
7%
Hyperkalaemia
7%
Erythema
7%
Ear pain
7%
Oral pain
6%
Arthralgia
6%
Anxiety
6%
Abdominal pain upper
6%
Dyspepsia
6%
Saliva altered
6%
Febrile neutropenia
5%
Oedema peripheral
5%
Back pain
5%
Dyspnoea
5%
Hypertension
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Trismus
3%
Laryngeal oedema
3%
Pneumonia aspiration
3%
Sepsis
3%
Pneumonitis
2%
Cellulitis
2%
Malnutrition
2%
Pharyngeal haemorrhage
1%
Colitis
1%
Mouth haemorrhage
1%
Oesophagitis
1%
Death
1%
General physical health deterioration
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Hypersensitivity
1%
Abscess neck
1%
Bronchitis
1%
Clostridium difficile colitis
1%
Device related infection
1%
Septic shock
1%
Stoma site infection
1%
Systemic infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Pulmonary embolism
1%
Respiratory failure
1%
Acute myocardial infarction
1%
Cardiac arrest
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B (Pembrolizumab + VEGF-TKI)Experimental Treatment4 Interventions
Preoperative treatment consists of 200 mg pembrolizumab IV on day 1 of each cycle, and 5mg axitinib (a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)) PO BID on days 1-42 of each cycle. Axitinib maybe titered in select patients after cycle 1. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of pre-operative treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with an R0 or R1 resection receive 400 mg pembrolizumab and 1, 3, 5, 7 or 10 mg axitinib PO BID every 42 days for up to 9 cycles (1 year), and patients with an R2 resection receive pembrolizumab IV and axitinib PO BID every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Group II: Cohort A (Pembrolizumab monotherapy)Experimental Treatment3 Interventions
Preoperative treatment consists of 200mg pembrolizumab IV on day 1 of each cycle. Treatment repeats every 21 days for up to 3 cycles (9 weeks).
Within 14-21 days following the end of treatment, patients undergo standard of care CN or MET. Patients with PD may undergo CN or MET per physician discretion.
Within 21-42 days after surgery, patients with R0 resection or R1 resection receive 400 mg pembrolizumab every 42 days for up to 9 cycles (1 year) and patients with R2 resection receive pembrolizumab every 42 days for up to 18 cycles (2 years) in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2630
Find a Location
Closest Location:University of California, San Francisco· San Francisco, CA· 2113 miles
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,632 Previous Clinical Trials
19,031,128 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,093 Previous Clinical Trials
5,230,860 Total Patients Enrolled
David Y Oh, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I am a woman who can have children and I had a positive pregnancy test recently.I have received an organ or tissue transplant from another person.I have or had lung inflammation treated with steroids.My kidney cancer has been confirmed to have clear cells.I am 18 years old or older.My recent tests show my organs are functioning well.My tumor can be biopsied and I agree to have it done.I am currently on medication for an infection.I have been diagnosed with HIV.I haven't had a heart attack or stroke in the last 6 months.I have an active TB infection.I have had a solid organ or bone marrow transplant.My high blood pressure is not well-managed despite taking medication.I am fully active or restricted in physically strenuous activity but can do light work.I am not eligible for surgery or targeted therapy for my condition.I have another cancer that is getting worse or was treated in the last 2 years.I have not had any serious wounds, ulcers, or bone fractures in the last 28 days.I have not experienced brain function issues in the last 6 months.I have previously received treatments targeting immune checkpoints.I have received systemic therapy for kidney cancer.My kidney cancer does not have clear cells.I have noticeable swelling in my abdomen.I have been treated for an autoimmune disease in the last 2 years.I am scheduled for CN and/or MET surgery.Your disease can be measured using a specific set of guidelines by the investigator.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.You have a severe allergic reaction (grade 3 or higher) to pembrolizumab or axitinib, or any of the ingredients in these medications.I haven't had cancer treatments like targeted therapy or radiation in the last 2 weeks.My cancer has spread beyond its original location.I agree to use birth control during and up to 120 days after the study.My cancer has spread to the bones but can't be measured by standard tests.I have active brain metastases or carcinomatous meningitis.I have had severe GI bleeding in the last 3 months.I have a history of hepatitis B or an active hepatitis C infection.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A (Pembrolizumab monotherapy)
- Group 2: Cohort B (Pembrolizumab + VEGF-TKI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.