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Cytokine
Anti-PD-1 + Aldesleukin for Melanoma and Kidney Cancer
Phase 2
Recruiting
Led By Stephanie L Goff, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have measurable disease (per RECIST v1.1 criteria), metastatic melanoma or renal cell cancer
Participants must have histologically or cytologically confirmed cancer falling into one of three specified cohorts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose through 30 days after last treatment
Awards & highlights
Study Summary
This trial is studying the combination of pembrolizumab and aldesleukin to see how well it works compared to pembrolizumab alone in treating participants with metastatic or advanced melanoma or renal cell carcinoma.
Who is the study for?
Adults over 18 with advanced melanoma or renal cell carcinoma can join this trial. They must not have HIV, hepatitis B/C, be pregnant, or breastfeeding. Participants need to have finished any previous cancer treatments at least four weeks prior and agree to use birth control. They should be in good health otherwise, without severe infections or immune system problems.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Aldesleukin and Pembrolizumab given through IV for metastatic melanoma and renal cell carcinoma. The treatment involves hospital stays during cycles and follow-ups for up to five years including physical exams, scans, blood tests.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used (Aldesleukin & Pembrolizumab), as well as risks associated with IV therapy such as infection at the injection site. Other common drug-related issues might involve fatigue, skin reactions, flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have melanoma or kidney cancer that can be measured for changes.
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My cancer type fits into one of the specified groups.
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I am fully active or can carry out light work.
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I am 18 years old or older.
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My organs and bone marrow work well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first dose through 30 days after last treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose through 30 days after last treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate in treatment refractory disease
Secondary outcome measures
Progression Free Survival
Response rate in treatment naive melanoma
Safety and tolerance
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1 - Pembro and IL-2Experimental Treatment2 Interventions
Course 1: pembrolizumab (200 mg IV) on Day 1 of each cycle with aldesleukin (600,000 IU/kg intravenous bolus every eight hours) continuing for up to 4 days (maximum 10 doses) for 2 cycles (each 21 days). Course 2: pembrolizumab (200 mg IV) on Day 1 of each cycle for 2 cycles (each 21 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
2012
Completed Phase 4
~1620
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,667 Previous Clinical Trials
40,926,054 Total Patients Enrolled
557 Trials studying Melanoma
193,112 Patients Enrolled for Melanoma
Stephanie L Goff, M.D.Principal InvestigatorNational Cancer Institute (NCI)
2 Previous Clinical Trials
53 Total Patients Enrolled
2 Trials studying Melanoma
53 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have melanoma or kidney cancer that can be measured for changes.You do not have hepatitis B or hepatitis C in your blood.You tested negative for HIV.My cancer type fits into one of the specified groups.You have a condition that weakens your immune system from birth.It has been over 4 weeks since my last systemic therapy.You had a serious allergic reaction to pembrolizumab or aldesleukin in the past.I am currently on steroid medication.I do not have any active infections, bleeding disorders, or serious illnesses that are not under control.You must have a test that shows you are not pregnant.I am fully active or can carry out light work.You have infections that can be dangerous because of a weakened immune system.If you have a history of heart problems, your heart's pumping ability (LVEF) should be at least 45%.I have had severe side effects from immunotherapy affecting my heart, lungs, gut, or liver.I have had heart surgery or symptoms due to poor blood flow.I have an autoimmune disease affecting a major organ.My lung function test shows less than or equal to 50% efficiency.I am 18 years old or older.My organs and bone marrow work well.
Research Study Groups:
This trial has the following groups:- Group 1: 1 - Pembro and IL-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.
Has Pembrolizumab received official government sanctioning?
"Given that this is a Phase 2 trial and there is only some data supporting safety, our team at Power has rated Pembrolizumab as being a 2 on our scale."
Answered by AI
How many research participants are in this study at most?
"That is correct, the online clinical trial registry does show that this study is actively looking for participants. The listing was created on August 18th, 2022 and edited November 17th, 2022. They are hoping to enroll 78 people total from 1 location."
Answered by AI
What is Pembrolizumab indicated to treat?
"Pembrolizumab is the standard of care for malignant neoplasms. This immunotherapy drug is also approved by major health organizations to treat unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Answered by AI
Are new participants currently being accepted for this research project?
"That is correct. The trial is currently ongoing, as indicated by the latest update being from November 17th, 20202. This particular study was originally posted on August 8th, 20202 and is seeking 78 individuals total from a single location."
Answered by AI
Could you please elaborate on Pembrolizumab's medical research history?
"Pembrolizumab is being investigated in 1057 active studies, the majority of which are Phase 3 clinical trials. The largest number of these trials for Pembrolizumab are based in Nashville, Tennessee; however, there are a total of 36419 locations running trials for this medication."
Answered by AI
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