Status:
WITHDRAWN
Time Restricted Eating (TRE) in Metastatic Head and Neck Squamous Cell Cancer (mHNSCC) or Unresectable or Metastatic Renal Cell Carcinoma (RCC)
Lead Sponsor:
Duke University
Conditions:
Metastatic Head-and-neck Squamous-cell Carcinoma
Unresectable Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate whether Time Restricted Eating (TRE) can improve responses in participants with metastatic head and neck squamous cell cancer (mHNSCC) or unresectable/metastat...
Eligibility Criteria
Inclusion
- HNSCC Cohort
- Histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell cancer that is not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy) and initiating standard of care immune checkpoint blocker- (Nivolumab, pembrolizumab, Atezolizumab, Avelumab or Durvalumab with or without chemotherapy), for the first time.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Age ≥18 years, able to understand and voluntarily consent.
Exclusion
- BMI \< 18.5.
- Diabetes mellitus, pregnancy, any eating disorder including anorexia nervosa or bulimia.
- Ongoing or active infection requiring iv antibiotics, autoimmune disease requiring systemic steroids greater than prednisone 60 mg equivalent, symptomatic congestive heart failure, unstable angina pectoris, insulin use, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who have known leptomeningeal metastases or untreated or symptomatic brain metastases. Eligible patients must be neurologically asymptomatic and not requiring steroids.
- Has received prior therapy with any anti-PD-1, anti-PDL-1 in a metastatic setting.
- Patients for whom fasting is medically contraindicated
- RCC Cohort
- Inclusion Criteria:
- Histologically or cytologically confirmed unresectable/metastatic clear cell renal cell carcinoma that is not amenable to local therapy with curative intent (surgery, radiation therapy, cryoablation, etc.,) and initiating standard of care systemic therapy consisting of immune checkpoint blockade (e.g. ipilimumab/nivolumab, cabozantinib/nivolumab, lenvatinib/pembrolizumab, or axitinib/pembrolizumab) for the first time.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as outlined in RECIST version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Age ≥18 years, able to understand and voluntarily consent.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06603155
Start Date
November 1 2025
End Date
June 1 2026
Last Update
December 19 2025
Active Locations (1)
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1
Duke Cancer Center
Durham, North Carolina, United States, 27705