Actively Recruiting
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-08
78
Participants Needed
1
Research Sites
471 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Aldesleukin is used to treat metastatic or advanced melanoma and renal cell carcinoma. Pembrolizumab is used to treat many cancers including melanoma. Researchers want to see if these drugs can be used together to produce better results in people with these types of cancer. Objective: To learn if the combination of pembrolizumab and aldesleukin can be used to treat metastatic or advanced melanoma and renal cell cancer. Eligibility: Adults aged 18 years or older who have metastatic or advanced melanoma or renal cell carcinoma. Design: Participants will be screened with: * Medical history * Physical exam * Electrocardiogram * Blood and urine tests * Ability to perform tasks of daily living * Imaging scans (CT, MRI, PET, and/or X-rays). They may get a contrast agent to enhance the images. * Photographs, if needed Some of these tests will be repeated during the study. Participants will receive the study drugs by IV (a plastic tube that is put into a vein) for 4 days. A second cycle of treatment will be given 21 days later. They will stay in the hospital for each of the cycles in the first course of treatment. After 2 months, their cancer will be evaluated. They may receive a second course of pembrolizumab alone on Days 1 and 21. They will not have to stay in the hospital for this course. About 30 days after treatment ends, participants will have a safety follow-up visit. Then they will have visits every 3 months for up to 1 year, and then every 6 months for up to 4 years. Follow-up can also be done by phone, email, and mail. If their cancer gets worse, they will stop having visits. Participation will last for 5 years.
CONDITIONS
Official Title
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older.
- Participants must have histologically or cytologically confirmed metastatic melanoma or renal cell carcinoma, with measurable disease.
- Participants must belong to one of the following groups: metastatic or advanced locoregional melanoma refractory to anti-PD-1 therapy; metastatic renal cell carcinoma refractory to at least one PD-1/PD-L1 therapy; or metastatic or advanced locoregional melanoma naive to anti-PD-1 therapy.
- Clinical performance status must be ECOG 0 or 1.
- Participants must be willing to use birth control from enrollment through four months after treatment.
- Participants must have a negative pregnancy test.
- Participants must be seronegative for HIV antibody.
- Participants must be seronegative for hepatitis B antigen and hepatitis C antibody; if hepatitis C antibody positive, they must test negative for HCV RNA.
- Participants must have adequate organ and marrow function based on specified blood counts and liver/kidney function tests.
- More than four weeks must have passed since any prior systemic therapy.
- Participants must be able to understand and willing to sign informed consent and Durable Power of Attorney forms.
- Participants must be co-enrolled on protocol 03-C-0277.
You will not qualify if you...
- Participants who are nursing.
- Participants receiving concurrent systemic steroid therapy.
- Participants with active systemic infections requiring treatment, coagulation disorders, or other major uncompensated medical illnesses.
- Participants with any form of primary immunodeficiency.
- Participants with a history of major organ autoimmune disease.
- Participants with Grade 3 or 4 major organ immune-related adverse events from anti-PD-1/PD-L1 monotherapy.
- Participants with concurrent opportunistic infections.
- Participants with a history of severe hypersensitivity to pembrolizumab or aldesleukin.
- Participants with a history of coronary revascularization or ischemic symptoms.
- Participants with left ventricular ejection fraction (LVEF) ≤ 45% if cardiac evaluation is indicated.
- Participants with forced expiratory volume in 1 second (FEV1) ≤ 50% if pulmonary evaluation is indicated.
- Participants currently receiving other investigational agents.
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI SB Immunotherapy Recruitment Center
CONTACT
S
Stephanie L Goff, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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