Metastatic Head and Neck Squamous Cell CarcinomaPhase 2POPPYNCT03813836
Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC
A Phase 2 study testing Pembrolizumab in people with Metastatic Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, run by University College, London at 12 sites in United Kingdom.
Trial summary
A single-arm phase II trial to assess the efficacy and safety profile of pembrolizumab in patients with performance status of 2 with recurrent or metastatic squamous cell carcinoma of the head and neck. Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months 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, Recurrent Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- 5 Jul 2019to 31 Jan 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 confirmed locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies
- Measurable disease evaluated by RECIST criteria version 1.1
- WHO performance status of 2
- Life expectancy >12 weeks
- Aged ≥18 years of age
- Adequate bone marrow function
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- Adequate renal function
- Adequate liver function
- Willing to use highly effective contraception for the duration of trial treatment and for 120 days after completion of treatment
- Able to give informed consent, indicating that the patient has been informed of and understands the experimental nature of the study, possible risks and benefits, trial procedures, and alternative options
- Willing and able to comply with the protocol for the duration of the study, including the treatment plan, investigations required and follow up visits
Who cannot join
- Patients with undifferentiated nasopharyngeal or sino-nasal cancers
- Disease suitable for treatment with curative intent
- Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent
- Any investigational agents within 4 weeks prior to registration
- Anti-cancer monoclonal antibody therapy within 4 weeks prior to registration
- Chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to registration
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- Patients with concurrent or previous malignancy that could compromise assessment of the primary or secondary endpoints of the trial
- Women who are pregnant or breast feeding
- Grade 3 or 4 peripheral neuropathy
- Any serious and/or unstable pre-existing medical, psychiatric or other condition that, in the treating clinician's judgment, could interfere with patient safety or obtaining informed consent
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active hepatitis B or C infection
- Immunocompromised patients (e.g. known HIV positive status)
- Prior organ transplantation including allogenic stem-cell transplantation
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids, or current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy
- Received a live vaccine within 30 days prior to registration
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
- Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent.
- Current use of immunosuppressive medication (exceptions apply) Refer to section 7.2 for full list of eligibility criteria
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites
Aberdeen Royal Infirmary (NHS Grampian)
Aberdeen
Bristol Haematology and Oncology Centre (University Hospital Bristol NHS Foundation Trust)
Bristol
Western General Hospital (NHS Lothian)
Edinburgh
East Suffolk and North Essex NHS Foundation Trust
Ipswich
Guy's and St Thomas' NHS Foundation Trust
London
University College London Hospital
London
The Christie NHS Foundation Trust
Manchester
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral
East and North Hertfordshire NHS Trust
Northwood
Queens Hospital (Barking, Havering and Redbridge University Hospitals NHS Trust)
Romford
Musgrove Park Hospital (Somerset NHS Foundation Trust)
Taunton
Royal Cornwall Hospital Trust
Truro
About this study
Official title: A Phase II Trial to Assess the Efficacy and Safety Profile of Pembrolizumab in Patients With Performance Status 2 With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
A single-arm phase II trial to assess the efficacy and safety profile of pembrolizumab in patients with performance status of 2 with recurrent or metastatic squamous cell carcinoma of the head and neck. Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
- Conditions
- Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
- Being tested
- Pembrolizumab
- Keywords
- Head and Neck Cancer, Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Pembrolizumab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
| Study group | Role | What they receive |
|---|---|---|
| pembrolizumab + best supportive care | Experimental | Best supportive care and pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate at 24 weeks assessed using iRECIST
Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST
Measured: 24 weeks after registration
Secondary outcomes (8)
Disease control rate assessed using iRECIST
Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST
Measured: 12 months after registration
Best Response Rate- measured using the change from baseline tumour size. Assessed using iRECIST.
Best Response Rate, defined as proportion of patients who have a CR or PR as their best response, measured using the change from baseline tumour size, assessed using iRECIST
Measured: 6 months after registration
Clinical Benefit Rate -defined as patient's best response rate lasting at least 18 weeks
Clinical Benefit Rate, defined as proportion patients who have achieved CR, PR or SD as their best response lasting at least 18 weeks
Measured: From start of treatment to 30 months post start of treatment
Duration of Response- defined as the time from first documented evidence of CR or PR until disease progression or death.
Duration of Response, defined as the time from first documented evidence of CR or PR until disease progression or death
Measured: From start of treatment to 30 months post start of treatment
Time to Progression -defined as time from registration to the first documented disease progression
Time to Progression, defined as time from registration to the first documented disease progression
Measured: From registration to 30 months post start of treatment
Progression Free Survival defined as the time from registration to the first documented disease progression or death due to any cause, whichever occurs first.
Progression Free Survival, defined as the time from registration to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: From registration to 30 months post start of treatment
Overall Survival- defined as the time from registration to death due to any cause.
Overall Survival, defined as the time from registration to death due to any cause.
Measured: From registration to 30 months post start of treatment
Frequency and severity of adverse events- throughout the patient's treatment and until 6 months after completion of trial treatment.
Frequency and severity of adverse events
Measured: From date of registration until 6 months after completion of trial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start5 Jul 2019
- Primary completion10 Jan 2024
- Study completion31 Jan 2026 (estimated)
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 University College, LondonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Martin Forster, FRCP PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813836
- Sponsor's protocol ID
- UCL/17/0396
- Acronym
- POPPY
- Status last verified
- Nov 2024
- First submitted
- 15 Jan 2019
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Assess the Efficacy and Safety Profile of Pembrolizumab in Patients With Performance Status 2 With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT03813836
- Acronym / sponsor ID
- POPPY / UCL/17/0396
- Conditions
- Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and Neck Cancer, Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Pembrolizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 23 Jan 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.
A single-arm phase II trial to assess the efficacy and safety profile of pembrolizumab in patients with performance status of 2 with recurrent or metastatic squamous cell carcinoma of the head and neck. Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pembrolizumab + best supportive care | Experimental | Drug: PembrolizumabBest supportive care and pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies
- Measurable disease evaluated by RECIST criteria version 1.1
- WHO performance status of 2
- Life expectancy >12 weeks
- Aged ≥18 years of age
Key exclusion criteria (20 listed)
- Patients with undifferentiated nasopharyngeal or sino-nasal cancers
- Disease suitable for treatment with curative intent
- Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent
- Any investigational agents within 4 weeks prior to registration
- Anti-cancer monoclonal antibody therapy within 4 weeks prior to registration
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 |
|---|---|---|
| PembrolizumabAlso: KeytrudaPatients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months | Drug | pembrolizumab + best supportive care |
Primary outcome
Disease control rate at 24 weeks assessed using iRECIST
Time frame: 24 weeks after registration
Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST
8 secondary outcomes
Disease control rate assessed using iRECIST
Time frame: 12 months after registration
Best Response Rate- measured using the change from baseline tumour size. Assessed using iRECIST.
Time frame: 6 months after registration
Clinical Benefit Rate -defined as patient's best response rate lasting at least 18 weeks
Time frame: From start of treatment to 30 months post start of treatment
Duration of Response- defined as the time from first documented evidence of CR or PR until disease progression or death.
Time frame: From start of treatment to 30 months post start of treatment
Time to Progression -defined as time from registration to the first documented disease progression
Time frame: From registration to 30 months post start of treatment
Progression Free Survival defined as the time from registration to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: From registration to 30 months post start of treatment
Overall Survival- defined as the time from registration to death due to any cause.
Time frame: From registration to 30 months post start of treatment
Frequency and severity of adverse events- throughout the patient's treatment and until 6 months after completion of trial treatment.
Time frame: From date of registration until 6 months after completion of trial treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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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.
Martin Forster, FRCP PhD principal investigator
University College, London
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Metastatic Head and Neck Squamous Cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, run by University College, London at 12 sites in United Kingdom.
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 11 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Disease control rate at 24 weeks assessed using iRECIST (time frame: 24 weeks after registration). 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 12 Nov 2024.