Status:
ACTIVE_NOT_RECRUITING
Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC
Lead Sponsor:
University College, London
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Metastatic Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 nec...
Eligibility Criteria
Inclusion
- Histologically confirmed locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck that is considered incurable by local therapies
- Measurable disease evaluated by RECIST criteria version 1.1
- WHO performance status of 2
- Life expectancy \>12 weeks
- Aged ≥18 years of age
- Adequate bone marrow function
- Adequate renal function
- Adequate liver function
- Willing to use highly effective contraception for the duration of trial treatment and for 120 days after completion of treatment
- 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
- 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
- Patients with undifferentiated nasopharyngeal or sino-nasal cancers
- Disease suitable for treatment with curative intent
- Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent
- Any investigational agents within 4 weeks prior to registration
- Anti-cancer monoclonal antibody therapy within 4 weeks prior to registration
- Chemotherapy, targeted small molecule therapy, or radiotherapy within 2 weeks prior to registration
- Patients with concurrent or previous malignancy that could compromise assessment of the primary or secondary endpoints of the trial
- Women who are pregnant or breast feeding
- Grade 3 or 4 peripheral neuropathy
- 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
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active hepatitis B or C infection
- Immunocompromised patients (e.g. known HIV positive status)
- Prior organ transplantation including allogenic stem-cell transplantation
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids, or current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy
- Received a live vaccine within 30 days prior to registration
- 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
- Active autoimmune disease that might deteriorate when receiving an immune-stimulatory agent.
- Current use of immunosuppressive medication (exceptions apply) Refer to section 7.2 for full list of eligibility criteria
Key Trial Info
Start Date :
July 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2026
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03813836
Start Date
July 5 2019
End Date
January 31 2026
Last Update
November 12 2024
Active Locations (12)
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1
Aberdeen Royal Infirmary (NHS Grampian)
Aberdeen, United Kingdom
2
Bristol Haematology and Oncology Centre (University Hospital Bristol NHS Foundation Trust)
Bristol, United Kingdom
3
Western General Hospital (NHS Lothian)
Edinburgh, United Kingdom
4
East Suffolk and North Essex NHS Foundation Trust
Ipswich, United Kingdom