Clinical Stage IV Cutaneous Melanoma AJCC v8NCT06391099

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

A study testing Best Practice, Biospecimen Collection and Computed Tomography in people with Clinical Stage IV Cutaneous Melanoma AJCC v8 and Metastatic Cutaneous Melanoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Renal Cell Carcinoma
What is being tested?: Best Practice, Biospecimen Collection and Computed Tomography
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 17 Nov 2025to 31 Dec 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210

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About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

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:

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
Being tested: Best Practice, Biospecimen Collection, Computed Tomography, Dietary Intervention, Educational Activity
Medical subject headings: Melanoma, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Best PracticeOther
Also called standard of care, standard therapy
Undergo standard of care diet
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood and stool sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Under CT
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Undergo ketogenic diet
Educational ActivityOther
Receive coaching support
Glucose MeasurementOther
Also called GLUC, Glucose
Undergo blood glucose testing
Ketone MeasurementOther
Also called Ketones
Undergo ketone measurement
Questionnaire AdministrationOther
Ancillary studies

Study groups in NCT06391099
Study group	Role	What they receive
Arm I (Ketogenic diet)	Experimental	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 CT, undergo blood sample collection and may undergo stool sample collection on the study. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Dietary Intervention; Other: Educational Activity; Other: Glucose Measurement; Other: Ketone Measurement; Other: Questionnaire Administration
Arm II (usual caare)	Active comparator	Patients follow a standard of care diet on the study. Receives: Other: Best Practice

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of adverse events
Will be assessed by immune-related adverse events (irAEs), serious adverse events (SAEs), Treatment Emergent Adverse Events (TEAEs), clinical laboratory, vital signs, physical examinations. Will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, which also includes irAEs. Grade 3, 4 and 5 toxicities will be reported as adverse events.
Measured: Up to 1 year
Adherence (feasibility measure)
Adherence will be defined as > 80% of days in ketosis and compliant as collecting all gut microbiome specimens. Diet adherence and progress will be assessed daily using at-home whole capillary blood glucose and continuous ketone monitoring devices
Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Nov 202531 Dec 2027

First posted30 Apr 2024
Study start17 Nov 2025
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Why it stopped: pending amendment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Clinical Stage IV Cutaneous Melanoma AJCC v8Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06391099
Sponsor's protocol ID: OSU-21335
Other IDs: NCI-2024-01894
Status last verified: May 2026
First submitted: 25 Apr 2024
Last updated: 26 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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