Ketogenic diet to enhance immunotherapy response in advanced melanoma and kidney cancer
Phase I Study of the Safety and Feasibility of a Ketogenic Dietary Intervention to Improve Response to Immunotherapy
This study tests if following a ketogenic diet can help people with advanced melanoma and kidney cancer respond better to immunotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | nivolumab, ipilimumab, pembrolizumab, immunotherapy |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06391099 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a ketogenic dietary intervention in improving the response to immunotherapy for patients with metastatic melanoma and metastatic kidney cancer. Participants will be randomized into two groups: one following a ketogenic diet with personalized coaching and monitoring, and the other adhering to a standard diet. The study aims to assess the safety and feasibility of this dietary approach while also exploring the relationship between the microbiome and tumor response. Patients will undergo regular monitoring and assessments throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed metastatic melanoma or metastatic renal cell carcinoma receiving first-line immunotherapy.
Not a fit: Patients who are not eligible include those under 18 years old or those unable to adhere to a ketogenic diet.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of immunotherapy in patients with advanced melanoma and kidney cancer.
How similar studies have performed: While the use of dietary interventions in cancer treatment is an emerging field, this specific approach combining a ketogenic diet with immunotherapy is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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) Exclusion Criteria: * 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
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Marium Husain, MD, MPH — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.