Clinical trial NCT06391099: Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer
Official title: Phase I Study of the Safety and Feasibility of a Ketogenic Dietary Intervention to Improve Response to Immunotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Cutaneous Melanoma
Metastatic Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 1 year
measure: Adherence (feasibility measure)
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Marium Husain, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: