Squamous Cell Carcinoma of the Head and NeckPhase 1PEACHNCT02819752
PEmbrolizumab Combined With Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck
A Phase 1 study testing Pembrolizumab, Radiotherapy and Chemotherapy in people with Squamous Cell Carcinoma of the Head and Neck and Squamous Cell Carcinoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to establish whether the combination of pembrolizumab (MK-3475) and conventional cisplatin-based chemoradiotherapy is tolerable and results in acceptable levels of acute and late toxicity in patients with stage IV LA-SCCHN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma
- What is being tested?
- Pembrolizumab, Radiotherapy and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jul 2017to 28 Nov 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have treatment naive and histologically confirmed high-/intermediate-risk LA-SCCHN
- Be willing and able to provide written informed consent for the trial.
- Be > or = 18 years of age on day of signing informed consent.
- Have measurable disease based on RECIST 1.1.
- Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumour lesion.
- Have a performance status of 0 or 1 on the ECOG Performance Scale.
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- Be fit for definitive platin-based chemoradiation therapy.
- Demonstrate adequate organ function as defined in table 1, all screening labs should be performed within 10 days of confirmation of study eligibility.
- Female patient of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to confirmation of study eligibility. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female patient s of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 6.7.2). Patient s of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Male patient s should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Who cannot join
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Has received prior radiotherapy to the head and neck region.
- Has a 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.
- Has had a prior monoclonal antibody, chemotherapy, targeted small molecule therapy, or radiation therapy.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patient s with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
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- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patient s with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Patient s with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has active tuberculosis.
- Has known hypersensitivity to pembrolizumab or any of its excipients.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- Has received a live vaccine within 30 days prior to the first dose of trial treatment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Marsden Hospital NHS Foundation Trust
London, SW3 6JJ
About this study
Official title: Phase I Dose-escalation Study of PEmbrolizumab (MK3475) Anti-PD1 Immune Checkpoint Inhibitor Combined With Radical Chemoradiotherapy in Patients With Stage IV Squamous Cell Carcinoma of the Head and Neck
This study aims to establish whether the combination of pembrolizumab (MK-3475) and conventional cisplatin-based chemoradiotherapy is tolerable and results in acceptable levels of acute and late toxicity in patients with stage IV LA-SCCHN. In particular, the study will provide data on the levels of mucosal and cutaneous toxicity within the radiation fields, as these are the primary acute toxicities associated with this treatment regimen. In addition, toxicity outside the radiation portals (which may theoretically be exacerbated by radiation) will be studied. However, all toxicity will be monitored. This study will also give an indication of the activity of pembrolizumab in LA-SCCHN because we are deliberately selecting a group of patients with high- and intermediate-risk disease who have a significant chance of experiencing loco-regional or systemic failure.
Read the detailed description
This will be a single centre phase 1 dose-escalation study to confirm the safety of combining pembrolizumab with standard platin-based chemoradiotherapy in patients with stage IV high- and intermediate-risk locally-advanced squamous cell carcinoma of the head and neck (LA-SCCHN). 6-36 patients (18 HPV+ve and 18 HPV-ve) will be recruited in a standard 3+3 dose-escalation trial design with an expansion cohort at the maximum tolerated dose (or 200 mg, if no DLT is defined). A pre-loading dose of 100 or 200mg (dependent on dosing level) of pembrolizumab will be given once the patient has completed the screening period. Patients will then return 2 weeks later to begin cycle 1 of a regimen of pembrolizumab 3 weekly at a dose of 100 or 200mg (dependent on dosing level) for a total of 7 cycles (3 during chemoradiotherapy and 4 after chemoradiotherapy).
Parallel studies in HPV-ve and HPV +ve disease will be conducted (note these patients may have different patterns of co-morbidity and, hence, different treatment-related toxicities). The primary endpoint of the study will be safety and tolerability. Dose-limiting acute toxicity will be assessed during administration of study drug according to CTCAEv4.0. The maximum tolerated dose of study drug (or 200 mg in the absence of DLT) will be used in a subsequent randomised phase 2 study comparing standard-of-care therapy with standard-of-care therapy plus study drug.
- Being tested
- Pembrolizumab, Radiotherapy, Chemotherapy
- Keywords
- squamous cell carcinoma, squamous cell carcinoma of the head and neck
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called MK-3475/pembrolizumab (KEYTRUDA®)
Pembrolizumab
RadiotherapyRadiation
Also called 70 Gy in 35 fractions
Radiotherapy - Standard Treatment
ChemotherapyDrug
Also called Cisplatin 100 mg/m2 or Carboplatin Area under the curve (AUC) = 5) on days 1, 22, 43
Chemotherapy - Standard Treatment
| Study group | Role | What they receive |
|---|---|---|
| HPV-ve stage IVA/IVB SCCHN | Experimental | Pembrolizumab and Chemoradiotherapy Receives: Drug: Pembrolizumab; Radiation: Radiotherapy; Drug: Chemotherapy |
| HPV+ve stage IVA/IVB SCCHN | Experimental | Pembrolizumab and Chemoradiotherapy Receives: Drug: Pembrolizumab; Radiation: Radiotherapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Patients With Dose Limiting Toxicities (DLT).
To establish the maximum tolerated dose that can safely be combined with platin-based chemoradiotherapy in patients with HPV-ve and HPV+ve LA-SCCHN.
Measured: Six weeks after the completion of chemoradiotherapy
Acute Toxicity as Measured During Treatment by CTCAE v4.0
Count and percentage of patients with any CTCAE graded toxicity from start of trial treatment until 6 weeks following end of treatment
Measured: Up until 6 weeks after the end of chemoradiotherapy (week 14 of the study)
Secondary outcomes (4)
Percentage of Progression Free Survival at 6, 12 and 24 Months Post Treatment Start.
Calculated as percentage of evaluable patients alive and disease free at each time point.
Measured: Six months, one year and two years
Percentage of Overall Survival at 6, 12 and 24 Months
Calculated as percentage of evaluable patients alive at each time point
Measured: Six months, one year and two years
Percentage of Patients With Clinical Benefit (CR/PR/SD) Using RECIST at 6, 12 and 24 Months
Calculated as percentage of evaluable patients with clinical benefit (CR/PR/SD) using RECIST at 6, 12 and 24 months
Measured: Six months, one year and two years
Percentage of Patients With Any Grade 1 Plus RTOG Toxicities
Calculated as percentage of patients with any grade 1 toxicities from start of treatment up to 52 weeks from the end of radiotherapy.
Measured: 52 weeks from the end of radiation therapy (week 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start12 Jul 2017
- Primary completion28 Nov 2019
- Study completion28 Nov 2019
Why it stopped: funding pulled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel studies in HPV-ve and HPV +ve disease will be conducted (note these patients may have different patterns of co-morbidity and, hence, different treatment-related toxicities). Both the HPV-ve and HPV+ve arms will run simultaneously.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Kevin Harrington, CTU, Study director, Consultant Clinical Oncologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819752
- Sponsor's protocol ID
- CCR4325
- Acronym
- PEACH
- Status last verified
- Mar 2026
- First submitted
- 22 Jun 2016
- Last updated
- 9 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-escalation Study of PEmbrolizumab (MK3475) Anti-PD1 Immune Checkpoint Inhibitor Combined With Radical Chemoradiotherapy in Patients With Stage IV Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT02819752
- Acronym / sponsor ID
- PEACH / CCR4325
- Keywords
- squamous cell carcinoma, squamous cell carcinoma of the head and neck
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding pulled
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom, Merck Sharp & Dohme LLC
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 28 Nov 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Posted 18 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to establish whether the combination of pembrolizumab (MK-3475) and conventional cisplatin-based chemoradiotherapy is tolerable and results in acceptable levels of acute and late toxicity in patients with stage IV LA-SCCHN. In particular, the study will provide data on the levels of mucosal and cutaneous toxicity within the radiation fields, as these are the primary acute toxicities associated with this treatment regimen. In addition, toxicity outside the radiation portals (which may theoretically be exacerbated by radiation) will be studied. However, all toxicity will be monitored. This study will also give an indication of the activity of pembrolizumab in LA-SCCHN because we are deliberately selecting a group of patients with high- and intermediate-risk disease who have a significant chance of experiencing loco-regional or systemic failure.
Detailed description
This will be a single centre phase 1 dose-escalation study to confirm the safety of combining pembrolizumab with standard platin-based chemoradiotherapy in patients with stage IV high- and intermediate-risk locally-advanced squamous cell carcinoma of the head and neck (LA-SCCHN). 6-36 patients (18 HPV+ve and 18 HPV-ve) will be recruited in a standard 3+3 dose-escalation trial design with an expansion cohort at the maximum tolerated dose (or 200 mg, if no DLT is defined). A pre-loading dose of 100 or 200mg (dependent on dosing level) of pembrolizumab will be given once the patient has completed the screening period. Patients will then return 2 weeks later to begin cycle 1 of a regimen of pembrolizumab 3 weekly at a dose of 100 or 200mg (dependent on dosing level) for a total of 7 cycles (3 during chemoradiotherapy and 4 after chemoradiotherapy).
Parallel studies in HPV-ve and HPV +ve disease will be conducted (note these patients may have different patterns of co-morbidity and, hence, different treatment-related toxicities). The primary endpoint of the study will be safety and tolerability. Dose-limiting acute toxicity will be assessed during administration of study drug according to CTCAEv4.0. The maximum tolerated dose of study drug (or 200 mg in the absence of DLT) will be used in a subsequent randomised phase 2 study comparing standard-of-care therapy with standard-of-care therapy plus study drug.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel studies in HPV-ve and HPV +ve disease will be conducted (note these patients may have different patterns of co-morbidity and, hence, different treatment-related toxicities). Both the HPV-ve and HPV+ve arms will run simultaneously.
| Arm | Type | Receives |
|---|---|---|
| HPV-ve stage IVA/IVB SCCHN | Experimental | Drug: Pembrolizumab, Radiation: Radiotherapy, Drug: ChemotherapyPembrolizumab and Chemoradiotherapy |
| HPV+ve stage IVA/IVB SCCHN | Experimental | Drug: Pembrolizumab, Radiation: Radiotherapy, Drug: ChemotherapyPembrolizumab and Chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have treatment naive and histologically confirmed high-/intermediate-risk LA-SCCHN
- Be willing and able to provide written informed consent for the trial.
- Be > or = 18 years of age on day of signing informed consent.
- Have measurable disease based on RECIST 1.1.
- Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumour lesion.
Key exclusion criteria (18 listed)
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
- Has received prior radiotherapy to the head and neck region.
- Has a 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.
- Has had a prior monoclonal antibody, chemotherapy, targeted small molecule therapy, or radiation therapy.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
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: MK-3475/pembrolizumab (KEYTRUDA®)Pembrolizumab | Drug | HPV+ve stage IVA/IVB SCCHN, HPV-ve stage IVA/IVB SCCHN |
| RadiotherapyAlso: 70 Gy in 35 fractionsRadiotherapy - Standard Treatment | Radiation | HPV+ve stage IVA/IVB SCCHN, HPV-ve stage IVA/IVB SCCHN |
| ChemotherapyAlso: Cisplatin 100 mg/m2 or Carboplatin Area under the curve (AUC) = 5) on days 1, 22, 43Chemotherapy - Standard Treatment | Drug | HPV+ve stage IVA/IVB SCCHN, HPV-ve stage IVA/IVB SCCHN |
Primary outcome
Number and Percentage of Patients With Dose Limiting Toxicities (DLT).
Time frame: Six weeks after the completion of chemoradiotherapy
To establish the maximum tolerated dose that can safely be combined with platin-based chemoradiotherapy in patients with HPV-ve and HPV+ve LA-SCCHN.
Acute Toxicity as Measured During Treatment by CTCAE v4.0
Time frame: Up until 6 weeks after the end of chemoradiotherapy (week 14 of the study)
Count and percentage of patients with any CTCAE graded toxicity from start of trial treatment until 6 weeks following end of treatment
4 secondary outcomes
Percentage of Progression Free Survival at 6, 12 and 24 Months Post Treatment Start.
Time frame: Six months, one year and two years
Percentage of Overall Survival at 6, 12 and 24 Months
Time frame: Six months, one year and two years
Percentage of Patients With Clinical Benefit (CR/PR/SD) Using RECIST at 6, 12 and 24 Months
Time frame: Six months, one year and two years
Percentage of Patients With Any Grade 1 Plus RTOG Toxicities
Time frame: 52 weeks from the end of radiation therapy (week 7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Prof Kevin Harrington, CTU study director
Consultant Clinical Oncologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pembrolizumab, Radiotherapy and Chemotherapy in people with Squamous Cell Carcinoma of the Head and Neck and Squamous Cell Carcinoma, run by Royal Marsden NHS Foundation Trust at 1 site 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 18 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: stopped early, as of the sponsor's last update on 9 Apr 2026. 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number and Percentage of Patients With Dose Limiting Toxicities (DLT). (time frame: Six weeks after the completion of chemoradiotherapy). The study lists 2 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 9 Apr 2026.