Actively Recruiting
Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-03-19
60
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females age 18 years or older
- Confirmed diagnosis of metastatic melanoma or metastatic renal cell carcinoma
- Receiving first-line treatment with combination nivolumab and ipilimumab or single agent PD-1 inhibitors such as nivolumab or pembrolizumab
- Scheduled for imaging every 6 to 12 weeks as per standard care guidelines
- Able to read, understand, and provide written informed consent
- Willing to provide stool samples for research
- Willing to participate in a ketogenic diet
You will not qualify if you...
- Younger than 18 years
- Unable or unwilling to provide consent
- Have type 1 diabetes or type 2 diabetes requiring insulin
- Clinically underweight with body mass index less than 18.5 at treatment start
- Have an active cancer other than treated and cured basal or squamous cell skin cancer or disease-free cancer for 5 years or more
- Currently consuming or have consumed a low-carbohydrate or ketogenic diet in the last 6 months
- Known to be pregnant
- Currently participating in another clinical trial involving active anti-cancer therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here