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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Overall Survival (OS) of Intent to Treat (ITT) Population
Progression Free Survival (PFS)
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
~700
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,465 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,544 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are involved in this research project?
"Unfortunately, this particular trial is not admitting patients at the moment. This study was originally posted on April 25th, 2017 and updated for the last time on November 10th, 2022. On the bright side, there are 431 other clinical trials related to renal cancer and 1057 studies involving Pembrolizumab that are currently looking for participants."
Answered by AI
Has Pembrolizumab been given the green light by the FDA?
"Pembrolizumab has received a score of 2 for safety. While there is some data supporting that it is safe, none of the research suggests that it is an effective medication."
Answered by AI
For what conditions is Pembrolizumab often given to patients?
"Pembrolizumab is an effective immunotherapy treatment for patients with malignant neoplasms, unresectable melanoma, and microsatellite instability high."
Answered by AI
Is it still possible to sign up for this research project?
"This study is not recruiting at the moment, according to the latest update on clinicaltrials.gov from November 10th, 2022. The trial was initially posted on April 25th, 2017. If you're looking for other studies, 431 trials are actively searching for patients with renal cancers while 1057 studies need participants who have Pembrolizumab."
Answered by AI
What other drugs has Pembrolizumab been tested against in previous clinical trials?
"At the moment, there are 1057 ongoing clinical studies involving pembrolizumab. Of those active trials, 127 are in Phase 3. Although many of the studies for pembrolizumab are based in Nashville, Tennessee, there are a total of 36428 locations running these kinds of trials."
Answered by AI
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