Metastatic Head-and-neck Squamous-cell CarcinomaNCT06603155
Time Restricted Eating (TRE) in Metastatic Head and Neck Squamous Cell Cancer (mHNSCC) or Unresectable or Metastatic Renal Cell Carcinoma (RCC)
A study testing Time restricted eating (TRE) in people with Metastatic Head-and-neck Squamous-cell Carcinoma and Unresectable Renal Cell Carcinoma, run by Duke University at 1 site in United States.
Trial 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/metastatic renal cell carcinoma (RCC) receiving Immune Checkpoint Blockers (ICB) by changing the gut microbiome (the bacteria… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Head-and-neck Squamous-cell Carcinoma, Unresectable Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
- What is being tested?
- Time restricted eating (TRE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Show all 13Show fewer
- RCC Cohort
- 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
- Patients for whom fasting is medically contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2, Single Arm Study to Evaluate the Efficacy of Time Restricted Eating (TRE) on Immunotherapy Treatment Outcomes in Patients With Metastatic Head and Neck Squamous Cell Cancer (mHNSCC) or Unresectable or Metastatic Renal Cell Carcinoma (RCC)
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/metastatic renal cell carcinoma (RCC) receiving Immune Checkpoint Blockers (ICB) by changing the gut microbiome (the bacteria and other microorganisms living in individual's bodies). A particular focus of this study is to compare the outcomes of African American participants when compared to the rest of the participant population. TRE is a form of intermittent fasting where food and drink intake is limited to a specific time window during the day. The information learned from this study may help researchers develop new strategies to improve outcomes in patients with mHNSCC and RCC in the future.
Participants will be asked to complete a dietary survey at baseline and week 9 and provide a baseline stool and blood sample. Two weeks before beginning ICB and after participants completed the baseline assessments, they will begin TRE. TRE will be defined as limiting food and drink intake to a 10 hour window during each day and fasting for 14 hours at night. Participants will be asked to complete a daily food log to document the times they eat and drink. On day 1 of ICB and weeks 3, 6, 9, 26, and 52 after ICB, participants will be asked to collect a blood sample and a toxicity assessment will be performed. On day 1 of ICB and weeks 9, 26, and 52 of ICB, participants will be asked to provide a stool sample. Participants will also undergo tumor imaging throughout the study as part of their standard of care assessments. If a participant's disease progresses after ICB, they will repeat all study assessments and be withdrawn from the study.
- Conditions
- Metastatic Head-and-neck Squamous-cell Carcinoma, Unresectable Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
- Being tested
- Time restricted eating (TRE)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eating (TRE)Behavioural
TRE is defined as limiting daily food intake to 10 hour period with a nightly fasting period of 14 hours.
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Eating (TRE) for mHNSCC participants | Experimental | Not described Receives: Behavioral: Time restricted eating (TRE) |
| Time Restricted Eating (TRE) for RCC participants | Experimental | Not described Receives: Behavioral: Time restricted eating (TRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median progression free survival (PFS) for HNSCC cohort only
Time from enrollment to radiographic disease progression as per RECIST 1.1 or death from any cause
Measured: 1 Year
Time restricted eating (TRE) associated change in gut microbiome
Microbiome changes in stool
Measured: Baseline, Day 1, Week 9, Week 26 and Week 52
Time restricted eating (TRE) associated change in metabolome
Metabolomics in blood
Measured: Baseline, Day 1, Week 9, Week 26 and Week 52
Time restricted eating (TRE) associated change in IGF1
IGF1 level in blood
Measured: Baseline, Day 1, Week 9, Week 26 and Week 52
Time restricted eating (TRE) associated change in immune repertoire
Comprehensive analysis of effector T cells and suppressor T cell populations in PBMC, plasma cytokines will be carried out
Measured: Baseline, Day 1, Week 9, Week 26 and Week 52
Response to immune checkpoint blocker (ICB) at first response assessment
Radiographic response as per RECIST 1.1
Measured: Week 9
Secondary outcomes (4)
1-year immune related adverse events (irAE) rate
1 year rate of irAE, as per CTCAE v.5
Measured: 1 Year
Feasibility of Time restricted eating (TRE) in African American HNSCC participants on immune checkpoint blocker (ICB)
Number of African American participants who were compliant, which is defined as 14 hr TRE daily for 5 days per week, for 9 out of first 12 weeks (70%)
Measured: Through Week 52
1-year immune related adverse events (irAE) rate in African American participants
1 year rate of irAE, as per CTCAE v.5 in African American participants
Measured: 1 year
Median progression free survival (PFS) for RCC cohort only
Time from enrollment to radiographic disease progression as per RECIST 1.1 or death from any cause
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startNov 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: Changing priorities of portfolio
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Head-and-neck Squamous-cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel George, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603155
- Sponsor's protocol ID
- Pro00115641
- Status last verified
- Dec 2025
- First submitted
- 17 Sep 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Single Arm Study to Evaluate the Efficacy of Time Restricted Eating (TRE) on Immunotherapy Treatment Outcomes in Patients With Metastatic Head and Neck Squamous Cell Cancer (mHNSCC) or Unresectable or Metastatic Renal Cell Carcinoma (RCC)
- ClinicalTrials.gov ID
- NCT06603155
- Acronym / sponsor ID
- Pro00115641
- Conditions
- Metastatic Head-and-neck Squamous-cell Carcinoma, Unresectable Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changing priorities of portfolio
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/metastatic renal cell carcinoma (RCC) receiving Immune Checkpoint Blockers (ICB) by changing the gut microbiome (the bacteria and other microorganisms living in individual's bodies). A particular focus of this study is to compare the outcomes of African American participants when compared to the rest of the participant population. TRE is a form of intermittent fasting where food and drink intake is limited to a specific time window during the day. The information learned from this study may help researchers develop new strategies to improve outcomes in patients with mHNSCC and RCC in the future.
Participants will be asked to complete a dietary survey at baseline and week 9 and provide a baseline stool and blood sample. Two weeks before beginning ICB and after participants completed the baseline assessments, they will begin TRE. TRE will be defined as limiting food and drink intake to a 10 hour window during each day and fasting for 14 hours at night. Participants will be asked to complete a daily food log to document the times they eat and drink. On day 1 of ICB and weeks 3, 6, 9, 26, and 52 after ICB, participants will be asked to collect a blood sample and a toxicity assessment will be performed. On day 1 of ICB and weeks 9, 26, and 52 of ICB, participants will be asked to provide a stool sample. Participants will also undergo tumor imaging throughout the study as part of their standard of care assessments. If a participant's disease progresses after ICB, they will repeat all study assessments and be withdrawn from the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Eating (TRE) for mHNSCC participants | Experimental | Behavioral: Time restricted eating (TRE) |
| Time Restricted Eating (TRE) for RCC participants | Experimental | Behavioral: Time restricted eating (TRE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted eating (TRE)TRE is defined as limiting daily food intake to 10 hour period with a nightly fasting period of 14 hours. | Behavioural | Time Restricted Eating (TRE) for RCC participants, Time Restricted Eating (TRE) for mHNSCC participants |
Primary outcome
Median progression free survival (PFS) for HNSCC cohort only
Time frame: 1 Year
Time from enrollment to radiographic disease progression as per RECIST 1.1 or death from any cause
Time restricted eating (TRE) associated change in gut microbiome
Time frame: Baseline, Day 1, Week 9, Week 26 and Week 52
Microbiome changes in stool
Time restricted eating (TRE) associated change in metabolome
Time frame: Baseline, Day 1, Week 9, Week 26 and Week 52
Metabolomics in blood
Time restricted eating (TRE) associated change in IGF1
Time frame: Baseline, Day 1, Week 9, Week 26 and Week 52
IGF1 level in blood
Time restricted eating (TRE) associated change in immune repertoire
Time frame: Baseline, Day 1, Week 9, Week 26 and Week 52
Comprehensive analysis of effector T cells and suppressor T cell populations in PBMC, plasma cytokines will be carried out
Response to immune checkpoint blocker (ICB) at first response assessment
Time frame: Week 9
Radiographic response as per RECIST 1.1
4 secondary outcomes
1-year immune related adverse events (irAE) rate
Time frame: 1 Year
Feasibility of Time restricted eating (TRE) in African American HNSCC participants on immune checkpoint blocker (ICB)
Time frame: Through Week 52
1-year immune related adverse events (irAE) rate in African American participants
Time frame: 1 year
Median progression free survival (PFS) for RCC cohort only
Time frame: 1 Year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Metastatic Head-and-neck Squamous-cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel George, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating (TRE) in people with Metastatic Head-and-neck Squamous-cell Carcinoma and Unresectable Renal Cell Carcinoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median progression free survival (PFS) for HNSCC cohort only (time frame: 1 Year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.