OncoMatch/Clinical Trials/NCT05155033
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Is NCT05155033 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Aldesleukin for metastatic melanoma.
Treatment: Pembrolizumab · Aldesleukin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Renal Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy
refractory to anti-PD-1 therapy
Must have received: PD-1/PD-L1 based therapy
refractory to at least one line of PD1/PDL1 based therapy
Lab requirements
Blood counts
ANC > 1000/mm^3 without the support of filgrastim; WBC >= 3000/mm^3; Platelet count >= 100,000/mm^3; Hemoglobin > 8.0 g/dL (Subject may be transfused to reach this cut-off)
Kidney function
Serum creatinine <= 1.6 mg/dL
Liver function
Serum ALT/AST <= 5.0 x ULN; Total bilirubin <= 2.0 mg/dL, except in participants with Gilbert s Syndrome, who must have a total bilirubin < 3.0 mg/dL.
Participants must have adequate organ and marrow function as defined below: * ANC > 1000/mm^3 without the support of filgrastim * WBC >= 3000/mm^3 * Platelet count >= 100,000/mm^3 * Hemoglobin > 8.0 g/d (Subject may be transfused to reach this cut-off) * Serum ALT/AST <= 5.0 x ULN * Serum creatinine <= 1.6 mg/dL * Total bilirubin <= 2.0 mg/dL, except in participants with Gilbert s Syndrome, who must have a total bilirubin < 3.0 mg/dL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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