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Tyrosine Kinase Inhibitor
Pembrolizumab +/− Axitinib for Renal Cell Carcinoma
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.
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.
Select...
I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has spread beyond its original location.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with >= 2-fold increase in the number of tumor-infiltrating immune cells (TIICs)
Secondary outcome measures
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 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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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
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 2
~2010
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,515 Previous Clinical Trials
15,244,383 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,899 Previous Clinical Trials
5,062,778 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree could Pembrolizumab be detrimental to one's health?
"Considering the Phase 2 status of this clinical trial, our team at Power has rated Pembrolizumab's safety as a 2 due to existing data indicating its security and lack thereof in terms of efficacy."
Answered by AI
In what types of conditions is Pembrolizumab customarily prescribed?
"Pembrolizumab is routinely administered to alleviate the symptoms of malignant neoplasms. In addition, it can be used in cases of unresectable melanoma, microsatellite instability high, and chemotherapy-induced disease progression."
Answered by AI
Can you elaborate on any prior experimentation conducted with Pembrolizumab?
"Currently, there are 1003 ongoing studies into pembrolizumab, with 125 of them being Phase 3 trials. Although Houston, Texas is a primary hub for such research efforts, 36703 different medical centres around the world are conducting such investigations."
Answered by AI
Is there a call for additional volunteers in this research endeavor?
"Affirmative. Clinicaltrials.gov data shows that this medical experiment, which was originally launched on February 9th of 2021, is currently recruiting participants. The target recruitment group size for the study is 84 individuals from a single clinical site."
Answered by AI
Could you provide an estimate of the number of participants enrolled in this clinical investigation?
"Affirmative. The information found on clinicaltrials.gov declares that the trial, originally made public on February 9th 2021, is still recruiting participants for a total of 84 across 1 site."
Answered by AI
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