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RECRUITING
NCT06391099
NA

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Sponsor: Ohio State University Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

This phase I trial studies how well a ketogenic dietary intervention works to improve response to immunotherapy in patients with melanoma and kidney cancer that has spread from where it first started (primary site) to other places in the body (metastatic). A ketogenic diet (KD) means eating fewer carbohydrates and more fats. The purpose is to use ketones (normal breakdown from fat) instead of glucose (sugar) as an energy source. Researchers want to see whether a ketogenic diet can improve tumor response in patients receiving immune checkpoint inhibitors (ICI). ICI are newer treatment options that help the immune system better fight some cancers. Following a KD may improve tumor response in patients with metastatic melanoma and metastatic kidney cancer treated with ICI.

Official title: Phase I Study of the Safety and Feasibility of a Ketogenic Dietary Intervention to Improve Response to Immunotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-11-17

Completion Date

2027-12-31

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

OTHER

Best Practice

Undergo standard of care diet

PROCEDURE

Biospecimen Collection

Undergo blood and stool sample collection

PROCEDURE

Computed Tomography

Under CT

OTHER

Dietary Intervention

Undergo ketogenic diet

OTHER

Educational Activity

Receive coaching support

OTHER

Glucose Measurement

Undergo blood glucose testing

OTHER

Ketone Measurement

Undergo ketone measurement

OTHER

Questionnaire Administration

Ancillary studies

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States