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Cytokine
IL-2 + Pembrolizumab for Kidney Cancer
Phase 2
Waitlist Available
Led By Jad Cuahoud, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age over 18 on day of signing informed consent.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Must not have
Myocardial infarction, stroke, coronary artery bypass surgery, coronary stent, or unstable angina within one year.
Has known history of, or any evidence of active, non-infectious pneumonitis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying how well IL-2 and pembrolizumab work in treating patients with melanoma.
Who is the study for?
Adults over 18 with metastatic kidney cancer, specifically clear cell renal carcinoma, who can provide consent and have measurable disease. They must be in good physical condition (ECOG 0 or 1), have proper organ function, agree to use contraception, and not be pregnant. Excluded are those with certain heart conditions, active infections requiring systemic therapy, known psychiatric or substance abuse disorders that could affect participation, recent use of investigational drugs or therapies including anti-PD-1/L1/L2 agents or monoclonal antibodies.
What is being tested?
The trial is testing the combination of Interleukin-2 (Proleukin™) and Pembrolizumab (Keytruda™) for treating metastatic kidney cancer. The study aims to evaluate the effects when these two treatments are used together.
What are the potential side effects?
Possible side effects include immune-related reactions such as inflammation in various organs like the lungs (pneumonitis), liver problems, skin rashes; infusion reactions from the drug administration; fatigue; hormonal gland issues like thyroid dysfunction; and an increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have kidney cancer that has spread, with clear cell features.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't had a heart attack, stroke, or major heart surgery in the last year.
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I have a history of or currently have non-infectious lung inflammation.
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I have been diagnosed with HIV.
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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
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I have an active TB infection.
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I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.
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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.
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I am currently being treated for an infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR)
Secondary study objectives
Overall Survival (OS) of Intent to Treat (ITT) Population
Progression Free Survival (PFS)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab and Interleukin-2Experimental Treatment2 Interventions
Outpatient Intravenous (IV) infusion of Pembrolizumab and Inpatient IV infusion of Interleukin-2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interleukin-2
1994
Completed Phase 3
~690
Pembrolizumab
2017
Completed Phase 3
~3150
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
562 Previous Clinical Trials
144,821 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,010 Previous Clinical Trials
5,185,216 Total Patients Enrolled
Prometheus LaboratoriesIndustry Sponsor
26 Previous Clinical Trials
4,769 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control during and for 4 months after the study.I haven't had a heart attack, stroke, or major heart surgery in the last year.You have a solid tumor that can be measured using specific criteria.I have another cancer besides the one being studied, but it's not getting worse or needing treatment, except for certain skin cancers or cervical cancer that's been treated.I have a history of or currently have non-infectious lung inflammation.I have been diagnosed with HIV.I am willing to provide a tissue sample for the study.I've had 0 or 1 cancer treatments in the last year and no PD-1 or PD-L1 therapies.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have an active TB infection.I don't have active brain cancer spread or symptoms, and haven't used steroids in the last 7 days.You currently have active Hepatitis B or Hepatitis C.I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have not received a live vaccine within the last 30 days, except for the flu shot.I am over 18 years old.I am fully active or restricted in physically strenuous activity but can do light work.I've had a heart test within the last 3 months or my doctor says it's not needed.I haven't had cancer treatment in the last 2 weeks and have recovered from past treatments, except for mild neuropathy.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have not been in a clinical trial for a new treatment or device in the last 4 weeks.I agree to follow strict birth control measures or abstain from sex during and 120 days after the study.I have kidney cancer that has spread, with clear cell features.You need to have a lung function test done within the last 3 months before starting the study.My organs are functioning well.I am currently being treated for an infection.You are allergic to pembrolizumab or any of the ingredients in it.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab and Interleukin-2
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.
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