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Cytokine
IL-2 + Radiotherapy + Pembrolizumab for Refractory Cancers
Phase 1 & 2
Recruiting
Research Sponsored by Megan Daly, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of three years
Awards & highlights
Summary
This trial is testing a new combination therapy for cancer that includes immunotherapy, radiation, and a new drug. It is designed to find the best dose of the new drug and to see if the combination therapy is safe and works better than current treatments.
Eligible Conditions
- Non-Small Cell Lung Cancer
- Melanoma
- Kidney Cancer
- Head and Neck Squamous Cell Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of three years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Abscopal response rate
Secondary study objectives
Maximum tolerated dose (MTD)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab/IL-2/RadiotherapyExperimental Treatment3 Interventions
All patients will receive pembrolizumab and intralesional IL-2 in combination with hypofractionated radiotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IL-2
2007
Completed Phase 4
~1180
Pembrolizumab
2017
Completed Phase 2
~2070
Radiotherapy
2017
Completed Phase 3
~2610
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Who is running the clinical trial?
Megan Daly, MDLead Sponsor
3 Previous Clinical Trials
55 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,938 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a lung condition called pneumonitis that needed treatment with steroids in the past, or you currently have pneumonitis.You have been diagnosed with HIV.You currently have Hepatitis B or Hepatitis C.You have at least one specific area that can be measured to see if the treatment is working.You are expected to live for at least 6 more months.You have a current infection that needs treatment with medication throughout your whole body.You have severe side effects from a previous treatment with PD-1 or PD-L1 drugs that have not gone away.You have another type of cancer that is getting worse or needs treatment.You have metastases in your brain or have carcinomatous meningitis.You have an ongoing autoimmune disease that needed strong medication in the last 2 years.You have had a serious autoimmune disease in the past.Your blood pressure is at least 80 when the heart is pumping.You cannot tolerate the type of medication being used in the study.You have had active tuberculosis in the past.You have a condition that weakens your immune system, or you are taking strong medicines that suppress your immune system within 7 days before starting the trial treatment.You have a disease that is not under control.Your organs must be working well, as shown in Table 2. All required lab tests must be done within 10 days before starting the treatment.You can join the study if you have a history of hypothyroidism and are taking a stable dose of thyroid replacement hormone.Adults 18 years or older with confirmed advanced lung, skin, kidney, or head and neck cancer.You do not have any other current cancer.You have taken strong medications that lower your immune system in the past 4 weeks.You didn't get better from a certain type of cancer treatment, or you got better at first but then got worse again.You are physically able to do light activities or work.You have a tumor that can be safely treated with radiotherapy and injections.Women who could become pregnant need to have a negative pregnancy test within 72 hours before starting the study medication.You are allergic to pembrolizumab or any of the ingredients in it.You have received another type of cancer treatment within 4 weeks before the study, or you have not recovered from side effects of a previous treatment given more than 4 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab/IL-2/Radiotherapy
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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