RecruitingPhase 2NCT05155033

Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma


Sponsor

National Cancer Institute (NCI)

Enrollment

78 participants

Start Date

Aug 18, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study is testing whether combining the immunotherapy drug pembrolizumab (anti-PD-1) with aldesleukin (IL-2, an immune-boosting protein) can help treat metastatic melanoma or metastatic clear cell renal cell carcinoma (kidney cancer) that has stopped responding to immunotherapy alone. **You may be eligible if...** - You are 18 or older with confirmed metastatic melanoma or metastatic kidney cancer (clear cell type) - Your cancer has progressed on prior immunotherapy, OR you have melanoma and have never received immunotherapy - You have measurable disease on scans - You are in good health (ECOG performance status 0 or 1) - Your blood counts and organ function meet required minimums - You are HIV-negative and hepatitis B/C-negative (or cured of hepatitis C) - You are enrolled or will co-enroll in a companion NIH protocol **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are on systemic steroid therapy - You have a history of severe immune-related side effects from prior immunotherapy (Grade 3–4) - You have an active serious infection, primary immune deficiency, or major autoimmune disease - You have had coronary artery procedures or a history of heart problems requiring cardiac evaluation - You are receiving another investigational treatment Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DRUGPembrolizumab

Pembrolizumab 200 mg IV over approximately 30 minutes on Day 1 of cycles 1 and 2 during Courses 1 and 2.

DRUGAldesleukin

Aldesleukin (IL-2) administration \[600,000 IU/kg IV bolus every 8 hours continuing for up to 4 days (maximum 10 doses)\] starting on Day 1 of cycles 1 and 2 during Course 1.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05155033


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