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

University College, London12 sites in 1 country63 target enrollmentJuly 5, 2019

ConditionsMetastatic Head and Neck Squamous Cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma

InterventionsPembrolizumab

DrugsPembrolizumab

Overview

Phase: Phase 2
Intervention: Pembrolizumab
Conditions: Metastatic Head and Neck Squamous Cell Carcinoma
Sponsor: University College, London
Enrollment: 63
Locations: 12
Primary Endpoint: Disease control rate at 24 weeks assessed using iRECIST
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

July 5, 2019

End Date

January 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University College, London

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Arms & Interventions

pembrolizumab + best supportive care

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

Intervention: Pembrolizumab

Outcomes

Primary Outcomes

Disease control rate at 24 weeks assessed using iRECIST

Time Frame: 24 weeks after registration

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

Secondary Outcomes

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)
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)
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)
Overall Survival- defined as the time from registration to death due to any cause.(From registration to 30 months post start of treatment)
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)