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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years post treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate
Secondary outcome measures
Drug Toxicity
Progression Free Survival
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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are IL-2 and Nivolumab novel treatments being trialed?
"747 studies are currently underway that involve IL-2 and Nivolumab. Of these, 82 have reached Phase 3. Basel, BE is where the majority of research takes place for this treatment; however, there are 40325 locations running trials globally."
Answered by AI
What are the risks associated with taking IL-2 and Nivolumab?
"Because this is a phase 2 trial, meaning that while there are some data supporting safety, none yet support efficacy, our team at Power estimates the safety of IL-2 and Nivolumab to be a 2."
Answered by AI
Have there been any other similar trials in the past?
"IL-2 and Nivolumab have been under research for a decade. In 2010, the first study was completed by Medarex. This initial study only involved 127 patients but it was enough to grant Phase 1 approval for IL-2 and Nivolumab as a drug combination. Presently, there are 747 different clinical trials being conducted in 2347 cities across 50 nations."
Answered by AI
What are IL-2 and Nivolumab most commonly used for?
"The IL-2 and Nivolumab treatment is most often used to fight cancerous neoplasms. However, it can also be used in the treatment of other conditions such as unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
Answered by AI
Can anyone sign up for this research project right now?
"That is correct, the online information hosted on clinicaltrials.gov affirms that this study is still recruiting patients. This research project was originally posted on 5/23/2019 and has been edited recently on 9/1/2021. The investigators are looking for 25 participants at a single site."
Answered by AI
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