Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
Head and Neck Cancer, Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Pembrolizumab
Brief 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
Interventions
DRUGPembrolizumab
Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
Sponsors
Merck Sharp & Dohme LLC
University College, London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed locally advanced, recurrent or metastatic squamous cell carcinoma 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 highly effective contraception for the duration of trial treatment and for 120 days after completion of treatment 10. 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 11. 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-nasal cancers 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. Active 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/interstitial lung disease that required steroids, or current pneumonitis/interstitial lung disease 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 to the 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) Refer to section 7.2 for full list of eligibility criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate at 24 weeks assessed using iRECIST | 24 weeks after registration | Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Response Rate- measured using the change from baseline tumour size. Assessed using iRECIST. | 6 months after registration | 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 |
| Clinical Benefit Rate -defined as patient's best response rate lasting at least 18 weeks | From start of treatment to 30 months post start of treatment | Clinical Benefit Rate, defined as proportion patients who have achieved CR, PR or SD as their best response lasting at least 18 weeks |
| Duration of Response- defined as the time from first documented evidence of CR or PR until disease progression or death. | 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 |
| Disease control rate assessed using iRECIST | 12 months after registration | Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST |
| Progression Free Survival defined as the time from registration to the first documented disease progression or death due to any cause, whichever occurs first. | 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. |
| Overall Survival- defined as the time from registration to death due to any cause. | From registration to 30 months post start of treatment | Overall Survival, defined as the time from registration to death due to any cause. |
| Frequency and severity of adverse events- throughout the patient's treatment and until 6 months after completion of trial treatment. | From date of registration until 6 months after completion of trial treatment | Frequency and severity of adverse events |
| Time to Progression -defined as time from registration to the first documented disease progression | From registration to 30 months post start of treatment | Time to Progression, defined as time from registration to the first documented disease progression |
Countries
United Kingdom
Outcome results
None listed