Phase II Trial of Pembrolizumab in Recurrent or Metastatic HNSCC

NCT03813836 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: UCL/17/0396
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 12

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

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

Outcome Measures

Primary Outcomes (1)

• Disease control rate at 24 weeks assessed using iRECIST

  Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST

  24 weeks after registration

Secondary Outcomes (8)

• Disease control rate assessed using iRECIST

  12 months after registration

• Best Response Rate- measured using the change from baseline tumour size. Assessed using iRECIST.

  6 months after registration

• 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

• 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

• Time to Progression -defined as time from registration to the first documented disease progression

  From registration to 30 months post start of treatment

Study Arms (1)

pembrolizumab + best supportive care

EXPERIMENTAL

Best supportive care and pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months

Also known as: Keytruda

pembrolizumab + best supportive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (12)

Aberdeen Royal Infirmary (NHS Grampian)

Aberdeen, United Kingdom

Location

Bristol Haematology and Oncology Centre (University Hospital Bristol NHS Foundation Trust)

Bristol, United Kingdom

Location

Western General Hospital (NHS Lothian)

Edinburgh, United Kingdom

Location

East Suffolk and North Essex NHS Foundation Trust

Ipswich, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

University College London Hospital

London, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, United Kingdom

Location

The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, United Kingdom

Location

East and North Hertfordshire NHS Trust

Northwood, United Kingdom

Location

Queens Hospital (Barking, Havering and Redbridge University Hospitals NHS Trust)

Romford, United Kingdom

Location

Musgrove Park Hospital (Somerset NHS Foundation Trust)

Taunton, United Kingdom

Location

Royal Cornwall Hospital Trust

Truro, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Study Officials

• Martin Forster, FRCP PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 23, 2019
• Study Start: July 5, 2019
• Primary Completion: January 10, 2024
• Study Completion: January 31, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

GB (12)