Clinical trial NCT03813836: Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
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
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2019-01-23
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Disease control rate at 24 weeks assessed using iRECIST
timeFrame: 24 weeks after registration
Secondary outcomes:
measure: Disease control rate assessed using iRECIST
timeFrame: 12 months after registration
measure: Best Response Rate- measured using the change from baseline tumour size. Assessed using iRECIST.
timeFrame: 6 months after registration
measure: Clinical Benefit Rate -defined as patient's best response rate lasting at least 18 weeks
timeFrame: From start of treatment to 30 months post start of treatment
measure: Duration of Response- defined as the time from first documented evidence of CR or PR until disease progression or death.
timeFrame: From start of treatment to 30 months post start of treatment
measure: Time to Progression -defined as time from registration to the first documented disease progression
timeFrame: From registration to 30 months post start of treatment
measure: Progression Free Survival defined as the time from registration to the first documented disease progression or death due to any cause, whichever occurs first.
timeFrame: From registration to 30 months post start of treatment
measure: Overall Survival- defined as the time from registration to death due to any cause.
timeFrame: From registration to 30 months post start of treatment
measure: Frequency and severity of adverse events- throughout the patient's treatment and until 6 months after completion of trial treatment.
timeFrame: From date of registration until 6 months after completion of trial treatment
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary (NHS Grampian)
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre (University Hospital Bristol NHS Foundation Trust)
city: Edinburgh
country: United Kingdom
facility: Western General Hospital (NHS Lothian)
city: Ipswich
country: United Kingdom
facility: East Suffolk and North Essex NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Northwood
country: United Kingdom
facility: East and North Hertfordshire NHS Trust
city: Romford
country: United Kingdom
facility: Queens Hospital (Barking, Havering and Redbridge University Hospitals NHS Trust)
city: Taunton
country: United Kingdom
facility: Musgrove Park Hospital (Somerset NHS Foundation Trust)
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital Trust
city: Wirral
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
Study officials:
affiliation: University College, London
name: Martin Forster, FRCP PhD
role: PRINCIPAL_INVESTIGATOR
References: