RecruitingNot ApplicableNCT06391099

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

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

Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

60 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Clinical Stage IV Cutaneous Melanoma AJCC v8 Metastatic Renal Cell Carcinoma Stage IV Renal Cell Cancer AJCC v8 Metastatic Cutaneous Melanoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether following a ketogenic diet (a very low-carb, high-fat diet) while receiving immunotherapy drugs can improve how well the treatment works for people with advanced melanoma (skin cancer) or kidney cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with metastatic melanoma or metastatic kidney cancer (including cases with brain metastases) - You are starting or currently receiving first-line immunotherapy (such as nivolumab, pembrolizumab, or ipilimumab) - You are willing and able to follow a ketogenic diet **You may NOT be eligible if...** - You have Type 1 diabetes or Type 2 diabetes managed with insulin - You are clinically underweight (BMI below 18.5) - You are already eating a low-carb diet - You have another active cancer (other than the one being treated) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBest Practice

Undergo standard of care diet

PROCEDUREBiospecimen Collection

Undergo blood and stool sample collection

PROCEDUREComputed Tomography

Under CT

OTHERDietary Intervention

Undergo ketogenic diet

OTHEREducational Activity

Receive coaching support

OTHERGlucose Measurement

Undergo blood glucose testing

OTHERKetone Measurement

Undergo ketone measurement

OTHERQuestionnaire Administration

Ancillary studies

Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT06391099

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