NCT06391099

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the safety and feasibility of establishing a ketogenic dietary intervention trial with longitudinal biospecimen collection in the Ohio State University Comprehensive Cancer Center (OSUCCC) cutaneous and genitourinary oncology clinics. EXPLORATORY OBJECTIVE: I. To assess whether the microbiome (binary, high versus \[vs\] low diversity) mediates the relationship between time in ketosis (days with peripheral blood beta-hydroxybutyric acid \[BHB\] \> 0.5 mM) and tumor size over the course of treatment. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo a ketogenic dietary intervention with personalized coaching from a dietician about the KD, which includes extensive educational and ongoing support on the KD and continuous ketone monitoring by talking to a dietician directly, with the ability to text a dietician at any time and expect a response within 12 hours over 24weeks. Patients also undergo daily blood glucose and ketone monitoring, undergo computed tomography (CT), undergo blood sample collection and may undergo stool sample collection on the study. ARM II: Patients follow a standard of care diet on the study.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-17
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-04-30
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States