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

Introduction

• Org Study ID: 10000354
• NTC ID: NCT05155033
• Lead Sponsor Name: National Cancer Institute (NCI)
• Status: RECRUITING

Conditions

• Clear Cell Renal Cell Carcinoma

Brief 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 Criteria

* INCLUSION CRITERIA:
* 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