Phase II Study of Pembrolizumab and Aldesleukin for Treating Advanced Melanoma and Kidney Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05155033

Provider View

This clinical trial is exploring whether combining two drugs, pembrolizumab and aldesleukin, can improve treatment outcomes for adults with advanced melanoma or kidney cancer that has spread.

Patient Parameters

Program Overview

This study aims to find out if using pembrolizumab and aldesleukin together can help treat advanced melanoma and kidney cancer that has spread. Pembrolizumab is already used for treating melanoma, and aldesleukin is used for both melanoma and kidney cancer. Researchers want to see if combining these drugs can lead to better results for patients.

Description

This study involves two main treatment courses. Each course includes two cycles of treatment, with each cycle lasting 21 days. In the first course, participants will receive pembrolizumab through an IV on the first day, followed by aldesleukin given every eight hours for up to 10 doses, depending on tolerance. A second cycle will start about three weeks later. After two months, participants will be evaluated to see how their cancer is responding. If the cancer has not progressed, they may receive a second course of pembrolizumab alone. Participants will be monitored regularly for up to five years to track their progress and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with advanced melanoma or kidney cancer that has spread.
  • Must have cancer that can be measured by scans.
  • Must be in good overall health, with a performance status score of 0 or 1.
  • Must agree to use birth control during the study and for four months after treatment.
  • Women must have a negative pregnancy test before starting treatment.
  • Must test negative for HIV, hepatitis B, and hepatitis C, or have these conditions under control.
  • Must have adequate blood cell counts and organ function as indicated by specific tests.
  • Must have completed any previous cancer treatments at least four weeks before starting the study.
  • Must understand the study and agree to sign informed consent.
  • Must be willing to sign a Durable Power of Attorney Form.
  • Must be co-enrolled in a related study protocol (03-C-0277).

Exclusion Criteria

  • Women who are breastfeeding due to potential risks to the baby.
  • Currently taking systemic steroids or other immunosuppressive medications.
  • Have active infections that require treatment or other serious medical conditions.
  • Have primary immunodeficiency disorders.
  • Have a history of severe autoimmune diseases affecting major organs.
  • Have had severe side effects from previous treatments with similar drugs.
  • Have a history of severe allergic reactions to pembrolizumab or aldesleukin.
  • Have a history of heart problems or low heart function.
  • Have significant lung problems, such as very low lung function.
  • Are participating in another clinical trial or taking investigational drugs.

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