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

NCT06391099 | Recruiting DMC

• 2 other identifiers: OSU-21335NCI-2024-01894
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Up to 1 year

Study Arms (2)

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.

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.

Other: Best Practice

Interventions

Best Practice OTHER

Undergo standard of care diet

Also known as: standard of care, standard therapy

Arm II (usual caare)

Biospecimen Collection PROCEDURE

Undergo blood and stool sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (Ketogenic diet)

Computed Tomography PROCEDURE

Under CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Arm I (Ketogenic diet)

Dietary Intervention OTHER

Undergo ketogenic diet

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Arm I (Ketogenic diet)

Educational Activity OTHER

Receive coaching support

Arm I (Ketogenic diet)

Glucose Measurement OTHER

Undergo blood glucose testing

Also known as: GLUC, Glucose

Arm I (Ketogenic diet)

Ketone Measurement OTHER

Undergo ketone measurement

Also known as: Ketones

Arm I (Ketogenic diet)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Ketogenic diet)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Melanoma; Carcinoma, Renal Cell

Interventions

Practice Guidelines as Topic; Standard of Care; Specimen Handling; Diet Therapy; Glucose; Ketones

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Nutrition Therapy; Therapeutics; Hexoses; Monosaccharides; Sugars; Carbohydrates; Organic Chemicals

Study Officials

• Marium Husain, MD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: November 17, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)