Head and Neck NeoplasmsEarly Phase 1NCT04188951
HFHS-1801-A Pilot Study of Immunotherapy As Consolidation Therapy for Patients with Recurrent Head and Neck Cancer
A Early Phase 1 study testing Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] in people with Head and Neck Neoplasms, run by Henry Ford Health System at 1 site in United States.
Trial summary
The study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2019to 8 May 2024
- Phase
- Early Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years or older, of either gender, with the ability to consent to participation in the study.
- Patients must have a history of squamous cell carcinoma of the head and neck involving any sub-site in the head and neck area except nasopharynx, paranasal sinuses, and salivary gland tumors.
- All patients must have recurred following definitive therapy with any combination of surgery, radiation, and/or chemotherapy.
- All patients must have undergone salvage surgery in an attempt to excise all recurrent disease.
- Salvage radiation therapy must not be an option available to the patient.
- Patients must have high risk features such extra nodal invasion, positive margins, perineural invasion or vascular embolism.
Who cannot join
- Patients with macroscopic residual disease
- Patient is eligible for radiation therapy.
- Performance status more than 2.
- Contraindications for immunotherapy, autoimmune disease, allergy to medication, steroid use at baseline.
- Patients with other previous cancers excluding CIN, DCIS, non-melanoma skin cancers
- Patients previously treated with immunotherapy <12months prior
- Patients with synchronous cancers "not included in the inclusion criteria"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HFHS-1801-A Pilot Study of Immunotherapy As Consolidation Therapy for Patients with Recurrent Head and Neck Cancer High Risk Pathologic Features Following Surgical Salvage and Are Not Eligible for Post-operative Radiation Therapy
The study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.
Read the detailed description
Approximately 30-40% of patients treated with a curative intent for locally advanced squamous cell carcinoma of the head and neck cancer will experience an isolated loco-regional recurrence or a second primary tumor in the previously radiated tissues1-5. Patients with recurrent head and neck cancer frequently recur locally and are still amenable for curative interventions. The current recommendations for treatment of these recurrent and second primary tumors includes surgical resection whenever possible as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy.
Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Many trials underway at the present time explore the use of immunotherapy in earlier stages of head and neck cancer than the ones already studied. However, patients undergoing salvage therapy are understudied and no major cooperative group or industry trial is addressing this group of patients.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
- Keywords
- Recurrent Head and Neck Cancer, Recurrent Head and Neck Neoplasms
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]Drug
Patients will receive 17 cycles of pembrolizumab via IV infusion of 200 mg over a period of 30 minutes, every 3 weeks starting no later than 90 days from the date of salvage head and neck therapy.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] | Other | Not described Receives: Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence at 1 year, will be measured by RECIST 1.1 as the primary measure for assessment of tumor, date of disease progression, and as a basis for all protocol guidelines related to disease status (e.g., discontinuation of study treatment).
Primary objective
Measured: 1 year
Secondary outcomes (3)
Determine the feasibility of immunotherapy for head and neck cancer following salvage surgery to produce preliminary data for 15 patients regarding efficacy. All side effects and symptoms will be assessed by CTCAE v5.0.
Study endpoint
Measured: 1 year
Rate of completion of all planned therapy. All drug related toxicities will be graded by CTCAE v5.0.
Study endpoint
Measured: through study completion, an average of 1 year
Toxicity rates measured by laboratory assessments and all adverse events and serious adverse events will be assessed by CTCAE v5.0.
Study endpoint
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start4 Oct 2019
- Primary completion15 Jun 2023
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haythem Ali, M.D., Henry Ford Health System
- Investigators
- Haythem Ali, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188951
- Sponsor's protocol ID
- HFHS-1801
- Status last verified
- Dec 2022
- First submitted
- 31 Oct 2019
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study is to obtain pilot data. The data may be shared with other researchers. Participants will sign a research HIPAA authorization to release their data. All participants will be assigned a study specific ID number.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HFHS-1801-A Pilot Study of Immunotherapy As Consolidation Therapy for Patients with Recurrent Head and Neck Cancer High Risk Pathologic Features Following Surgical Salvage and Are Not Eligible for Post-operative Radiation Therapy
- ClinicalTrials.gov ID
- NCT04188951
- Acronym / sponsor ID
- HFHS-1801
- Conditions
- Head and Neck Neoplasms
- Keywords
- Recurrent Head and Neck Cancer, Recurrent Head and Neck Neoplasms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 4 Oct 2019 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 6 Dec 2019 (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 study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.
Detailed description
Approximately 30-40% of patients treated with a curative intent for locally advanced squamous cell carcinoma of the head and neck cancer will experience an isolated loco-regional recurrence or a second primary tumor in the previously radiated tissues1-5. Patients with recurrent head and neck cancer frequently recur locally and are still amenable for curative interventions. The current recommendations for treatment of these recurrent and second primary tumors includes surgical resection whenever possible as this has been shown to have a significantly better outcome as compared to patients treated non-surgically with radiation therapy with or without concurrent chemotherapy.
Immunotherapy is expected to be more effective with smaller amounts of disease and application of therapy when disease burden is minimal is expected to yield improved outcomes. Many trials underway at the present time explore the use of immunotherapy in earlier stages of head and neck cancer than the ones already studied. However, patients undergoing salvage therapy are understudied and no major cooperative group or industry trial is addressing this group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] | Other | Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be 18 years or older, of either gender, with the ability to consent to participation in the study.
- Patients must have a history of squamous cell carcinoma of the head and neck involving any sub-site in the head and neck area except nasopharynx, paranasal sinuses, and salivary gland tumors.
- All patients must have recurred following definitive therapy with any combination of surgery, radiation, and/or chemotherapy.
- All patients must have undergone salvage surgery in an attempt to excise all recurrent disease.
- Salvage radiation therapy must not be an option available to the patient.
Key exclusion criteria (7 listed)
- Patients with macroscopic residual disease
- Patient is eligible for radiation therapy.
- Performance status more than 2.
- Contraindications for immunotherapy, autoimmune disease, allergy to medication, steroid use at baseline.
- Patients with other previous cancers excluding CIN, DCIS, non-melanoma skin cancers
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 |
|---|---|---|
| Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]Patients will receive 17 cycles of pembrolizumab via IV infusion of 200 mg over a period of 30 minutes, every 3 weeks starting no later than 90 days from the date of salvage head and neck therapy. | Drug | Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] |
Primary outcome
Rate of recurrence at 1 year, will be measured by RECIST 1.1 as the primary measure for assessment of tumor, date of disease progression, and as a basis for all protocol guidelines related to disease status (e.g., discontinuation of study treatment).
Time frame: 1 year
Primary objective
3 secondary outcomes
Determine the feasibility of immunotherapy for head and neck cancer following salvage surgery to produce preliminary data for 15 patients regarding efficacy. All side effects and symptoms will be assessed by CTCAE v5.0.
Time frame: 1 year
Rate of completion of all planned therapy. All drug related toxicities will be graded by CTCAE v5.0.
Time frame: through study completion, an average of 1 year
Toxicity rates measured by laboratory assessments and all adverse events and serious adverse events will be assessed by CTCAE v5.0.
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Yes. This study is to obtain pilot data. The data may be shared with other researchers. Participants will sign a research HIPAA authorization to release their data. All participants will be assigned a study specific ID number.
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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.
Haythem Ali, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] in people with Head and Neck Neoplasms, run by Henry Ford Health System 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 4 Dec 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of recurrence at 1 year, will be measured by RECIST 1.1 as the primary measure for assessment of tumor, date of disease progression, and as a basis for all protocol guidelines related to disease status (e.g., discontinuation of study treatment). (time frame: 1 year). 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 4 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.