Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC
NCT ID: NCT03813836
Last Updated: 2024-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
63 participants
INTERVENTIONAL
2019-07-05
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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pembrolizumab + best supportive care
Best supportive care and pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
Pembrolizumab
Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
Interventions
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Pembrolizumab
Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
University College, London
OTHER
Responsible Party
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Principal Investigators
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Martin Forster, FRCP PhD
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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Aberdeen Royal Infirmary (NHS Grampian)
Aberdeen, , United Kingdom
Bristol Haematology and Oncology Centre (University Hospital Bristol NHS Foundation Trust)
Bristol, , United Kingdom
Western General Hospital (NHS Lothian)
Edinburgh, , United Kingdom
East Suffolk and North Essex NHS Foundation Trust
Ipswich, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
University College London Hospital
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, , United Kingdom
East and North Hertfordshire NHS Trust
Northwood, , United Kingdom
Queens Hospital (Barking, Havering and Redbridge University Hospitals NHS Trust)
Romford, , United Kingdom
Musgrove Park Hospital (Somerset NHS Foundation Trust)
Taunton, , United Kingdom
Royal Cornwall Hospital Trust
Truro, , United Kingdom
Countries
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Other Identifiers
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UCL/17/0396
Identifier Type: -
Identifier Source: org_study_id
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