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

Launched by OHIO STATE UNIVERSITY COMPREHENSIVE CANCER CENTER · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how a special diet, called a ketogenic diet, might help patients with advanced melanoma and kidney cancer respond better to immunotherapy treatments. The ketogenic diet focuses on eating fewer carbohydrates (like bread and pasta) and more fats (like nuts and oils), which changes the way the body gets energy, potentially making it easier for the immune system to fight cancer. Researchers are interested in seeing if this diet can improve how well tumors respond to newer treatments that help boost the immune system's ability to attack cancer cells.

To participate in the trial, you need to be at least 18 years old and have a confirmed diagnosis of metastatic melanoma or metastatic kidney cancer. You should also be starting first-line immunotherapy treatment. Participants will follow the ketogenic diet and may need to provide stool samples for research analysis. The study is currently recruiting participants, and if you meet the eligibility criteria, you could play an important role in helping researchers learn more about this potential treatment approach.

Gender

ALL

Eligibility 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