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

NCT06391099 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

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

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

Sponsors & Collaborators

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Marium Husain, MD, MPH · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06391099 on ClinicalTrials.gov