RECRUITING

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

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Conditions

Clinical Stage IV Cutaneous Melanoma AJCC V8Metastatic Cutaneous MelanomaMetastatic Renal Cell CarcinomaStage IV Renal Cell Cancer AJCC V8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2025-02-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06391099

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females, age \>= 18 years
  2. * 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
  3. * 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)
  4. * 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
  5. * Able to read, understand, and provide written informed consent
  6. * Willing to provide stool specimen for research studies as outlined in the timeline
  7. * Willing to participate in a ketogenic diet (KD)
  1. * Individuals \< 18 years of age
  2. * Unable or unwilling to provide consent
  3. * Patients with type 1 diabetes mellitus or type 2 diabetes using insulin
  4. * Patients who are clinically underweight (body mass index \[BMI\] \< 18.5) at the start of treatment
  5. * 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)
  6. * Currently consuming a low-carbohydrate (\< 130 g/day) or ketogenic diet or done so in the last 6-months
  7. * 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
  8. * Patients currently participating in an interventional or therapeutic clinical trial involving the use of active anti-cancer therapy

Contacts and Locations

Study Contact

The Ohio State Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-02-01
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

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