Combination Pembrolizumab and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
This study is looking at whether combining two drugs, pembrolizumab and aldesleukin, can be an effective treatment for people with metastatic melanoma or renal cell carcinoma (a type of kidney cancer). Pembrolizumab is an immunotherapy that helps your immune system fight cancer, and aldesleukin is a drug that also stimulates the immune system. Researchers want to see if using these drugs together can lead to better outcomes, especially for those whose cancer has not responded to previous treatments. You may be able to join if you are an adult with metastatic or advanced melanoma or renal cell carcinoma that has not responded to prior anti-PD-1 based therapies.
- Study design
- This is an interventional study with a planned enrollment of 78 participants. It is designed to evaluate the objective response rate to the combination treatment.
- What's involved
- You will undergo screening tests including a medical history, physical exam, ECG, blood and urine tests, and imaging scans. Treatment involves receiving pembrolizumab and aldesleukin on specific days during cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your response to treatment will be measured at 8 weeks after the first course, then after the second course, every 3 months for one year, and every 6 months for up to five years.
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NCT05155033
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~78 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:PembrolizumabAldesleukin
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response rate in treatment refractory disease
Measured over 8 weeks after Course 1 Cycle 1 then after Course 2, every 3 months x 3 (up to one year), every 6 months x 8 (up to five years)
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Stephanie L Goff, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participants must have histologically or cytologically confirmed cancer that falls into one of three cohorts: (1) metastatic melanoma or advanced locoregional melanoma not amenable to curative surgical resection and refractory to anti-PD-1 therapy; (2) metastatic renal cell carcinoma (clear cell histology) refractory to at least one line of PD1/PDL1 based therapy; (3) metastatic or advanced locoregional melanoma not amenable to curative surgical resection and naive to anti-PD-1 therapy.
Participants must have measurable disease (per RECIST v1.1 criteria), metastatic melanoma or renal cell cancer.
Age \>=18 years of age.
Clinical performance status of ECOG 0 or 1.
Willing to practice birth control from the time of enrollment on this study and for four months after treatment.
Must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.
Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)
Seronegative for hepatitis B antigen and for hepatitis C antibody. If hepatitis C antibody test is positive, then participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
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.
More than four weeks must have elapsed since completion of any prior systemic therapy at the time of enrollment.
Ability of subject to understand and the willingness to sign a written informed consent document.
Willing to sign a Durable Power of Attorney Form.
Subject must be co-enrolled on protocol 03-C-0277
Exclusion
Participant is nursing because of the potentially dangerous effects of the treatment on the fetus or infant.
Concurrent systemic steroid therapy.
Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).
History of major organ autoimmune disease.
Grade 3 or 4 major organ irAEs following treatment with anti-PD-1/PD-L1 monotherapy, including but not limited to myocarditis, pneumonitis, colitis, and hepatotoxicity.
Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
History of severe immediate hypersensitivity reaction to pembrolizumab or aldesleukin.
History of coronary revascularization or ischemic symptoms.
For select participants with a clinical history prompting cardiac evaluation: last known LVEF \<= 45%.
For select participants with a clinical history prompting pulmonary evaluation: known FEV1 \<= 50%.
Participant is receiving any other investigational agents.
What this trial measures
- Response rate in treatment refractory disease8 weeks after Course 1 Cycle 1 then after Course 2, every 3 months x 3 (up to one year), every 6 months x 8 (up to five years)
Determine the rate of objective response (using RECIST v1.1 criteria)