Clinical Trial Finder

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

PRIMARY OBJECTIVE:

• I. 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:

• I. 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.

Arms

Experimental: Arm I (Ketogenic diet)

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.

Active Comparator: Arm II (usual caare)

Patients follow a standard of care diet on the study.

Interventions

Other: - Best Practice

Undergo standard of care diet

Procedure: - Biospecimen Collection

Undergo blood and stool sample collection

Procedure: - Computed Tomography

Under CT

Other: - Dietary Intervention

Undergo ketogenic diet

Other: - Educational Activity

Receive coaching support

Other: - Glucose Measurement

Undergo blood glucose testing

Other: - Ketone Measurement

Undergo ketone measurement

Other: - Questionnaire Administration

Ancillary studies