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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 6 weeks of prior anti-PD-1 therapy with documented clinical or radiographic progression. Last anti-PD-1 therapy must be within 6 months of enrollment
Histologically-confirmed diagnosis of unresectable stage III or metastatic (stage IV) melanoma or renal cell carcinoma
Must not have
Has any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
Concurrent systemic steroid therapy with doses above physiologic level (more than 10 mg of prednisone daily)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years post treatment
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Summary
This trial is testing a combination of drugs to treat melanoma and renal cell carcinoma. Doctors will assess how well the patients respond after each course of treatment.
Who is the study for?
Adults with metastatic melanoma or renal cell carcinoma who've previously tried anti-PD-1 therapy without success. They must be in good physical condition, not pregnant, willing to use birth control, and have recovered from previous treatments' side effects. Exclusions include active infections, other recent cancers (except certain localized ones), uncontrolled hypertension, mental conditions preventing consent, and certain medical histories like autoimmune diseases.
What is being tested?
The trial is testing the combination of nivolumab (an anti-PD-1 drug) and high-dose IL-2 to see if they can work together to treat patients whose cancer didn't respond to just anti-PD-1 treatment alone. Patients will receive these drugs for up to three courses and their response will be measured using standard criteria.
What are the potential side effects?
Potential side effects may include immune system reactions leading to inflammation in various organs, fatigue, allergic responses specific to the drugs used (nivolumab or IL-2), as well as risks associated with high doses of IL-2 which could affect heart or lung function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had anti-PD-1 therapy for over 6 weeks and my cancer progressed after.
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My melanoma or kidney cancer cannot be removed by surgery and is advanced.
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I am 18 years old or older.
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I am a man who can father a child and will use birth control.
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My side effects from previous treatments are mild, except for hair loss or skin changes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am mentally and physically capable of participating in a clinical trial.
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I am taking more than 10 mg of prednisone daily.
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I haven't had a heart attack or stroke in the last 6 months.
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I have an active case of tuberculosis.
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I have not had major surgery within the last 4 weeks.
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I am currently on medication for an infection.
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I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years post treatment
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
Secondary study objectives
Drug Toxicity
Progression Free Survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1Treatment groups
Experimental Treatment
Group I: High Dose IL-2 and NivolumabExperimental Treatment1 Intervention
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Who is running the clinical trial?
Gregory DanielsLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had anti-PD-1 therapy for over 6 weeks and my cancer progressed after.I am mentally and physically capable of participating in a clinical trial.I am fully active or restricted in physically strenuous activity but can do light work.I am taking more than 10 mg of prednisone daily.I haven't had a heart attack or stroke in the last 6 months.I am not pregnant and agree to use two forms of birth control.My melanoma or kidney cancer cannot be removed by surgery and is advanced.I haven't had serious wounds, ulcers, or bone fractures in the last 28 days.I have an active case of tuberculosis.I haven't taken experimental drugs in the last 21 days and have recovered from their side effects, except for anti-PD-1 treatments.I have at least one tumor that can be measured and was confirmed by imaging recently.I have an autoimmune disease but am not on high-dose steroids.My kidney function is good as tested within the last 28 days.I have not had another cancer besides skin, cervical, bladder, or prostate cancer under surveillance in the last 5 years.I can understand and am willing to sign the consent form.I am 18 years old or older.Your blood counts should be normal within the last 28 days before starting the treatment.My liver is functioning well, as tested within the last 28 days.My heart and lungs are strong enough for intensive treatment.I have not had major surgery within the last 4 weeks.Your blood clotting should be normal within the last 28 days before starting the treatment.I have brain metastases but they are either treated, not causing symptoms, or I am receiving necessary radiation.My high blood pressure has not been controlled for over 4 weeks despite treatment.I am a man who can father a child and will use birth control.I am currently on medication for an infection.I am not pregnant or breastfeeding.You are allergic to nivolumab or IL-2.My side effects from previous treatments are mild, except for hair loss or skin changes.
Research Study Groups:
This trial has the following groups:- Group 1: High Dose IL-2 and Nivolumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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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