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

Description

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

Clinical Stage IV Cutaneous Melanoma AJCC V8, Metastatic Cutaneous Melanoma, Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC V8

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Clinical Stage IV Cutaneous Melanoma AJCC V8
Intervention / Treatment

-

Contacts and Locations

Columbus

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Males and females, age \>= 18 years
  • * Clinical site A will include patients with confirmed diagnosis of metastatic melanoma (including those with brain metastases) receiving first line treatment with combination nivolumab and ipilimumab or single agent ipilimumab, nivolumab, pembrolizumab
  • * Clinical site B will include patients with confirmed diagnosis of metastatic renal cell carcinoma (RCC) (including those with brain metastases) receiving first line treatment with combination nivolumab and ipilimumab or single agent PD-1 inhibitor (e.g., nivolumab, pembrolizumab)
  • * Scheduled for imaging every 6 to 12 weeks for metastatic melanoma (MM) and mRCC as is standard of care per National Comprehensive Cancer Network (NCCN) guidelines
  • * Able to read, understand, and provide written informed consent
  • * Willing to provide stool specimen for research studies as outlined in the timeline
  • * Willing to participate in a ketogenic diet (KD)
  • * Individuals \< 18 years of age
  • * Unable or unwilling to provide consent
  • * Patients with type 1 diabetes mellitus or type 2 diabetes using insulin
  • * Patients who are clinically underweight (body mass index \[BMI\] \< 18.5) at the start of treatment
  • * Other active malignancy (other than adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or any other cancer from which the patient has been disease free \>=5 years)
  • * Currently consuming a low-carbohydrate (\< 130 g/day) or ketogenic diet or done so in the last 6-months
  • * Women who are known to be pregnant are excluded. However no additional pregnancy testing out of what would be recommended prior to initiating anti-cancer therapy will be performed solely for this study
  • * Patients currently participating in an interventional or therapeutic clinical trial involving the use of active anti-cancer therapy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ohio State University Comprehensive Cancer Center,

Marium Husain, MD, MPH, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

2026-12-31