Single-Center Trial on Ketogenic Diet and Immunotherapy in Advanced Cancer This Study Evaluates the Safety and Effects of a Ketogenic Diet (KD) Combined With Immunotherapy in Adults With Advanced Melanoma, cSCC, or RCC.

Launched by RABIN MEDICAL CENTER · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a ketogenic diet (a high-fat, low-carb diet) when combined with immunotherapy in adults with advanced skin cancer, specifically melanoma, cutaneous squamous cell carcinoma (cSCC), or renal cell carcinoma (RCC). The goal is to see if this diet can help improve the immune system’s response to treatment, as not all patients benefit equally from current immunotherapy options.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of one of the targeted cancers, currently receiving specific immunotherapy treatments. Participants will be divided into two groups: one will follow the ketogenic diet for ten weeks, while the other will maintain a standard diet. Throughout the study, they will receive support from a dietitian, monitor their food intake, and undergo regular health checks. This trial not only aims to improve treatment outcomes but also hopes to provide new insights into how diet can play a role in cancer care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • • Males and females, age \>= 18 years
• • Patients with a histologically confirmed melanoma or cSCC or RCC receiving first line treatment with combination nivolumab and ipilimumab /relatlimab or single agent ipilimumab, nivolumab, pembrolizumab, Cemiplimab.
• • Able to read, understand, and provide written informed consent
• • Willing and able to complete all study-specific procedures and visits
• • Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• * Blood tests:
• • Creatinine (Cr) \< 1.5 mg/dL.
• • Magnesium normal range ( 1.5 -2,6 mg/dL)
• • Liver function tests (LFTs) 2.5x upper limit of normal (ULN).
• • Neutrophils ≥ 1,000/mm3, platelets ≥ 50,000/mm3, Hb\>8 g/dL
• • Women of childbearing potential must have a negative β-HCG pregnancy test documented within 1 week of registration.
• Exclusion Criteria:
• • • Individuals \< 18 years of age
• • Unable or unwilling to provide consent
• • 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 \>=2 years)
• • Currently consuming a low-carbohydrate (\< 130 g/day) or KD or done so in the last 6-months
• • Patients currently participating in an interventional or therapeutic clinical trial involving the use of active anti-cancer therapy.
• • Active autoimmune diseases requiring active Immune suppressive medications
• • Systemic steroid therapy, excluding for replacement due to adrenal insufficiency
• • Major surgery within last 3 months
• • BMI \<18 or \>35
• • Medical contraindications to the intervention diet as determined by the treating physician.
• • Self-reported major dietary restrictions related to the intervention such as irritable bowel syndrome (IBS).
• • Patients with a history or active eating disorder
• • Uncontrolled Diabetes mellitus or patients receiving insulin
• • Known diagnosis of HIV
• • Known active hepatitis B or hepatitis C
• • Known inborn errors of lipid metabolism
• • Sever or uncontrolled Hyperlipidemia (total cholesterol over 400 mg / dL, low-density lipoprotein (LDL) above 300 mg / dL, triglycerides over 500 mg / dl.).
• • Pregnant or lactating.
• • Patients who have undergone a transplant