Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
Chief Investigator:
Martin Forster
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
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.

POPPY is a single-arm phase II trial which aims to evaluate the safety and anti-tumour activity of pembrolizumab in patients with recurrent or metastatic head and neck squamous cell cancer and a performance status of 2.

Patients will receive pembrolizumab 200 mg every 3 weeks, in addition to best supportive care. Treatment will continue for a maximum of 24 months.

This will be a multicentre trial in 10-15 UK sites.

Trial rationale: There is compelling preclinical and early clinical data supporting a potential role for pembrolizumab in HNSCC. However, there is incomplete understanding as to the most accurate predictors of activity in HNSCC. Preliminary clinical data suggest an association between PD-L1 expression and response rates but anti-tumour activity has been seen in tumours across all expression levels.

Many patients with HNSCC have impaired performance status, excluding them from many new therapies, including PD-1 inhibitors, as most clinical trials are restricted to patients with performance status of 0 or 1. All the studies reported with PD-1 inhibitors to date have been in patients of PS 0-1.

The activity of anti-tumour pembrolizumab within this patient population will be evaluated for the first time within this study.

PD-1 inhibitors are well tolerated with a favourable toxicity profile but there are very limited safety data in patients with poor PS. This study is also designed to evaluate the safety profile of pembrolizumab, along with preliminary anti-tumour activity data within this patient population.

Overall Aim: To evaluate the safety and anti-tumour activity of pembrolizumab in patients with recurrent or metastatic Head and Neck Squamous Cell Cancer and a performance status of 2.

Target accrual: 65 patients

Definition of end of trial: 30 months after the final patient starts treatment, or death of all patients, whichever is sooner.


Patients will receive best supportive care + Pembrolizumab 200 mg every 3 weeks, administered as a 30 minute IV infusion.   Patients will remain on treatment for a maximum of 24 months, if pembrolizumab is tolerated and there is no evidence of disease progression.

Key inclusion/exclusion criteria:

Inclusion criteria:

1. Histologically confirmed recurrent or metastatic squamous cellcarcinoma of the head and neck that is considered incurable by local therapies

2. Measurable disease evaluated by RECIST criteria version 1.1

3. WHO performance status of 2

4. Life expectancy >12 weeks

5. Aged ≥18 years of age

6. Adequate bone marrow function

7. Adequate renal function

8. Adequate liver function

9. Willing to use contraception for the duration of trial treatment and for 120 days after completion of treatment

10. Willing to have tissue biopsy if disease is accessible

11. 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

12. Willing and able to comply with the protocol for the duration of the study, including the treatment plan, investigations required and follow up visits

Exclusion criteria:

1. Patients with undifferentiated nasopharyngeal or sino-nasalcancers

2. Disease suitable for treatment with curative intent

3. Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent

4. Any investigational agents within 4 weeks prior to registration

5. Anti-cancer monoclonal antibody therapy within 4 weeks prior to registration

6. Chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to registration

7. Patients with concurrent or previous malignancy that could compromise assessment of the primary or secondary endpoints of the trial

8. Women who are pregnant or breast feeding

9. Grade 3 or 4 peripheral neuropathy

10. 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

11. Active central nervous system (CNS) metastases and/or carcinomatous meningitis

12. Known hepatitis B or C infection

13. Immunocompromised patients (e.g. known HIV positive status)

14. Prior organ transplantation including allogenic stem-cell transplantation

15. History of (non-infectious) pneumonitis that required steroids, or current pneumonitis

16. Active infection requiring systemic therapy

17. Received a live vaccine within 30 days prior to registration

18. Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior tot he first dose of trial treatment

19. Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent

20. Current use of immunosuppressive medication (exceptions apply)

Duration of recruitment: 24 months

Primary Endpoint

• Disease control rate at 24 weeks after registration, assessed using RECIST v1.1

Secondary Endpoints

• Disease control rate at 12 months, defined as a complete response, partial response or stable disease

• Best Response Rate, measured using the change from baseline tumour size, assessed using iRECIST

• Clinical benefit rate, defined as a complete response, partial response or stable disease, for at least 18 weeks from start of treatment

• Duration of response

• Time to progression (TTP)

• Progression free survival (PFS)

• Overall survival (OS)

• Frequency and severity of adverse events, recorded continuously in relation to each treatment cycle and graded using CTCAE criteria

 • Treatment related dose delays or treatment discontinuation due to toxicity

Exploratory biological studies: To explore the relationship between possible predictive biomarkers and response to pembrolizumab in blood, archival tumour tissue and where available, fresh tumour biopsies (e.g. immunecheckpoint expression, genetic variation, circulating biomarkers) 

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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